| Reported | Recall | Class | Product | Firm |
|---|
| 2018-06-27 | Z-2239-2018 | Class II | BEAD TIP GD WIRE 3 | Zimmer Biomet, Inc. |
| 2018-06-27 | Z-2240-2018 | Class II | 3 | Zimmer Biomet, Inc. |
| 2018-06-27 | Z-2241-2018 | Class II | RECON DRILL 6MM X 439MM | Zimmer Biomet, Inc. |
| 2018-06-27 | Z-2242-2018 | Class II | 3 | Zimmer Biomet, Inc. |
| 2018-06-27 | Z-2243-2018 | Class II | CritiCore Automated Urine Output and Temperature Monitor | C.R. Bard, Inc. |
| 2018-06-27 | Z-2244-2018 | Class II | Farabeuf Clamp for 3 | Stryker GmbH |
| 2018-06-27 | Z-2245-2018 | Class II | Part no | Synthes (USA) Products LLC |
| 2018-06-27 | Z-2246-2018 | Class II | Part no | Synthes (USA) Products LLC |
| 2018-06-27 | Z-2247-2018 | Class II | Part no | Synthes (USA) Products LLC |
| 2018-06-27 | Z-2248-2018 | Class II | Biograph mCT Systems: | Siemens Medical Solutions USA, Inc. |
| 2018-06-27 | Z-2249-2018 | Class II | Drainer | Vascular Solutions, Inc. |
| 2018-06-27 | Z-2250-2018 | Class II | Fabius GS Premium Anesthesia Machine | Draeger Medical, Inc. |
| 2018-06-27 | Z-2251-2018 | Class II | Fabius GS Tiro Anesthesia Machine | Draeger Medical, Inc. |
| 2018-06-27 | Z-2252-2018 | Class II | Fabius GS MRI Anesthesia Machine | Draeger Medical, Inc. |
| 2018-06-27 | Z-2253-2018 | Class II | Apollo Anesthesia Machine | Draeger Medical, Inc. |
| 2018-06-27 | Z-2254-2018 | Class II | Perseus A500 Anesthesia Machine | Draeger Medical, Inc. |
| 2018-06-27 | Z-2255-2018 | Class II | VNS Therapy Programmer | Cyberonics, Inc |
| 2018-06-27 | Z-2256-2018 | Class II | C2 CryoBalloon Focal Catheter | PENTAX of America Inc |
| 2018-06-27 | Z-2257-2018 | Class III | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The… | Quantimetrix Corporation |
| 2018-06-27 | Z-2258-2018 | Class II | The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an… | Becton Dickinson & Company |
| 2018-06-27 | Z-2259-2018 | Class II | The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an… | Becton Dickinson & Company |
| 2018-06-27 | Z-2260-2018 | Class II | The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an… | Becton Dickinson & Company |
| 2018-06-27 | Z-2261-2018 | Class II | P28 JAWS Nitinol Staple System kits are designed for use in an… | Paragon 28, Inc. |
| 2018-06-27 | Z-2262-2018 | Class II | Nitinol Staple | TriMed Inc. |
| 2018-06-27 | Z-2263-2018 | Class II | Nitinol Staple | TriMed Inc. |
| 2018-06-27 | Z-2264-2018 | Class II | Nitinol Staple | TriMed Inc. |
| 2018-06-27 | Z-2265-2018 | Class II | Nitinol Staple | TriMed Inc. |
| 2018-06-27 | Z-2266-2018 | Class II | CARESCAPE R860 ventilators with software version 10SP05 Product… | Datex-Ohmeda, Inc. |
| 2018-06-27 | Z-2267-2018 | Class II | Birmingham Hip Resurfacing Femoral Head: | Smith & Nephew, Inc. |
| 2018-06-27 | Z-2268-2018 | Class II | Birmingham Hip Resurfacing Acetabular Cup with Impactor: | Smith & Nephew, Inc. |
| 2018-06-27 | Z-2269-2018 | Class II | Olympus JF-140F duodenoscopes | Olympus Corporation of the Americas |
| 2018-06-27 | Z-2270-2018 | Class II | Olympus JF-160F duodenoscopes | Olympus Corporation of the Americas |
| 2018-06-27 | Z-2271-2018 | Class II | Cryovalve | CryoLife, Inc. |
| 2018-06-27 | Z-2272-2018 | Class II | Cryopatch SG Pulmonary Human Cardiac Branch | CryoLife, Inc. |
| 2018-06-20 | Z-2058-2018 | Class II | Cell Observer SD | Zeiss, Carl Inc |
| 2018-06-20 | Z-2060-2018 | Class II | Sonialvision Safire II | Shimadzu Medical Systems |
| 2018-06-20 | Z-2136-2018 | Class II | cobas e 801 immunoassay analyzer | Roche Diagnostics Corporation |
| 2018-06-20 | Z-2137-2018 | Class II | remel SUPERPACK CS/ 500 SEG/FLASK | Thermo Fisher |
| 2018-06-20 | Z-2138-2018 | Class II | 12C | Ion Beam Applications S.A. |
| 2018-06-20 | Z-2139-2018 | Class II | Proteus ONE and Proteus Plus | Ion Beam Applications S.A. |
| 2018-06-20 | Z-2140-2018 | Class III | lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls | Alere San Diego Inc. DBA Immunalysis Corporation |
| 2018-06-20 | Z-2141-2018 | Class II | IntelliVue MX40 Patient Monitor | Philips Electronics North America Corporation |
| 2018-06-20 | Z-2142-2018 | Class II | IntelliVue MX40 Patient Monitor | Philips Electronics North America Corporation |
| 2018-06-20 | Z-2143-2018 | Class II | IntelliVue MX40 Patient Monitor | Philips Electronics North America Corporation |
| 2018-06-20 | Z-2144-2018 | Class II | IntelliVue MX40 Patient Monitor | Philips Electronics North America Corporation |
| 2018-06-20 | Z-2145-2018 | Class II | STAT-Check MANUAL RESUSCITATOR / VENTILATOR | Sun Med, LLC |
| 2018-06-20 | Z-2146-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2147-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2148-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2149-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2150-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2151-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5 | Sun Med, LLC |
| 2018-06-20 | Z-2152-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2153-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2154-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2155-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2156-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2157-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2158-2018 | Class II | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK | Sun Med, LLC |
| 2018-06-20 | Z-2159-2018 | Class II | Aortic Arterial Cannula 20 Fr | Maquet Cardiopulmonary Ag |
| 2018-06-20 | Z-2160-2018 | Class II | Aortic Arterial Cannula 22 Fr | Maquet Cardiopulmonary Ag |
| 2018-06-20 | Z-2161-2018 | Class II | Aortic Arterial Cannula 24 Fr | Maquet Cardiopulmonary Ag |
| 2018-06-20 | Z-2162-2018 | Class II | Prima Plus ¿4 | Keystone Dental Inc |
| 2018-06-20 | Z-2163-2018 | Class II | smith&nephew GENESIS | Smith & Nephew, Inc. |
| 2018-06-20 | Z-2164-2018 | Class II | The VITEK 2 Gram-Positive identification card | BioMerieux SA |
| 2018-06-20 | Z-2165-2018 | Class II | The VITEK 2 Neisseria-Haemophilus identification card | BioMerieux SA |
| 2018-06-20 | Z-2166-2018 | Class II | The VITEK¿ 2 Anaerobic and Corynebacteria identification card | BioMerieux SA |
| 2018-06-20 | Z-2167-2018 | Class II | The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use… | BioMerieux SA |
| 2018-06-20 | Z-2168-2018 | Class II | The VITEK 2 Gram Negative Susceptibility Card is intended for use… | BioMerieux SA |
| 2018-06-20 | Z-2169-2018 | Class II | VIDAS TOXO IgG Avidity is an automated qualitative test for use on… | BioMerieux SA |
| 2018-06-20 | Z-2170-2018 | Class II | The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram… | BioMerieux SA |
| 2018-06-20 | Z-2171-2018 | Class II | Color Gram 2 | BioMerieux SA |
| 2018-06-20 | Z-2172-2018 | Class II | Oxidase Reagent | BioMerieux SA |
| 2018-06-20 | Z-2173-2018 | Class II | Proteus 235 The PTS is a medical device designed to produce and… | Ion Beam Applications S.A. |
| 2018-06-20 | Z-2174-2018 | Class II | Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351 | Philips Medical Systems (Cleveland) Inc |
| 2018-06-20 | Z-2175-2018 | Class II | Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741 | Philips Medical Systems (Cleveland) Inc |
| 2018-06-20 | Z-2176-2018 | Class II | Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741 | Philips Medical Systems (Cleveland) Inc |
| 2018-06-20 | Z-2177-2018 | Class II | Biomet Modular Primary Tibial Tray Implants | Zimmer Biomet, Inc. |
| 2018-06-20 | Z-2178-2018 | Class II | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB | Datascope Corporation |
| 2018-06-20 | Z-2179-2018 | Class II | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC… | Datascope Corporation |
| 2018-06-20 | Z-2180-2018 | Class II | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB | Datascope Corporation |
| 2018-06-20 | Z-2181-2018 | Class II | Dimension Gentamicin Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. |
| 2018-06-20 | Z-2182-2018 | Class II | Dimension Vista Gentamicin Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. |
| 2018-06-20 | Z-2183-2018 | Class II | Vanguard Knee System PS Tibial Bearing | Zimmer Biomet, Inc. |
| 2018-06-20 | Z-2184-2018 | Class II | CellaVision DM Software versions 6 | Cellavision AB |
| 2018-06-20 | Z-2185-2018 | Class II | Accu-Chek Aviva Plus Test Strip | Roche Diabetes Care, Inc. |
| 2018-06-20 | Z-2186-2018 | Class II | Accu-Chek Performa Test Strip | Roche Diabetes Care, Inc. |
| 2018-06-20 | Z-2187-2018 | Class II | Accu-Chek Inform II Test Strip | Roche Diabetes Care, Inc. |
| 2018-06-20 | Z-2188-2018 | Class II | XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2189-2018 | Class II | Bio-Stable 5F SL-55CM IR-145 Kit Valved PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2190-2018 | Class II | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2191-2018 | Class II | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2192-2018 | Class II | Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2193-2018 | Class II | Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2194-2018 | Class II | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2195-2018 | Class II | Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2196-2018 | Class II | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2197-2018 | Class II | Microintroducer Kit | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2198-2018 | Class II | BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two… | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2199-2018 | Class II | BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2200-2018 | Class II | RS TANDEM 5F DL XPP | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2201-2018 | Class II | RS 5F DL XPP | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2202-2018 | Class II | RS | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2203-2018 | Class II | RS 5F DL BIOFLO PICC | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2204-2018 | Class II | RS TANDEM 5F DL BIOFLO PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2205-2018 | Class II | RS 5F DL BIOFLO PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2206-2018 | Class II | TANDEM 5F DL BIOFLO PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2207-2018 | Class II | 5F DL BIOFLO PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2208-2018 | Class II | RS 5F DL BIOFLO PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2209-2018 | Class II | RS 5F DL BIOFLO PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2210-2018 | Class II | 5F DL BIOFLO PICC | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2211-2018 | Class II | RS 5F DL BIOFLO PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2212-2018 | Class II | RS TANDEM 5F DL XCELA PICC PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2213-2018 | Class II | RS 5F DL XPP KIT | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2214-2018 | Class II | RS 5F DL BIOFLO PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2215-2018 | Class II | RS TANDEM 5F DL BIOFLO PASV | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2216-2018 | Class II | RS TANDEM 5F DL BIOFLO PICC | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2217-2018 | Class II | CAN 5F DL BIOFLO PASV PICC NURSING TRAY | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2218-2018 | Class II | CAN 5F SINGLE XCELA PICC | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2219-2018 | Class II | CAN 5F DUAL XCELA PICC | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2220-2018 | Class II | Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2221-2018 | Class II | BioFlo PICC | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2222-2018 | Class II | BioFlo PICC | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2223-2018 | Class II | BioFlo PICC | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2224-2018 | Class II | BioFlo PICC | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2225-2018 | Class II | RS 5F DL XCELA PICC | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 2018-06-20 | Z-2226-2018 | Class II | Part #: SAM XT-M | The Seaberg Company Inc |
| 2018-06-20 | Z-2227-2018 | Class II | Part #: SAM XT-C | The Seaberg Company Inc |
| 2018-06-20 | Z-2228-2018 | Class II | Part #: SAM XT-C | The Seaberg Company Inc |
| 2018-06-20 | Z-2229-2018 | Class II | DermaPro Waterproof Silicone Tape | Safe N Simple, LLC |
| 2018-06-13 | Z-1614-2018 | Class II | 11-VI Incorporated Laser diode component Non-certified laser diode… | Ii - Vi Incorporated |
| 2018-06-13 | Z-1884-2018 | Class II | Santajoy Ornament & Giftware Co | SANTA JOY ORNAMENT & GIFTWARE CO |
| 2018-06-13 | Z-2046-2018 | Class I | Draeger Jaundice Meter JM-103 The device is intended for use in… | Draeger Medical Systems, Inc. |
| 2018-06-13 | Z-2047-2018 | Class I | Draeger Jaundice Meter JM-105 The device is intended for use in… | Draeger Medical Systems, Inc. |
| 2018-06-13 | Z-2050-2018 | Class II | nordicBrainEx 2 | NordicNeuroLab AS |
| 2018-06-13 | Z-2051-2018 | Class II | Restoris MCK Onlay Insert Extractor | Mako Surgical Corporation |
| 2018-06-13 | Z-2052-2018 | Class II | Hobbs Bronchial Cytology Brushes | Hobbs Medical, Inc. |
| 2018-06-13 | Z-2053-2018 | Class II | ADVIA Centaur BNP | Siemens Healthcare Diagnostics, Inc. |
| 2018-06-13 | Z-2054-2018 | Class II | ADVIA Centaur TSH3-Ultra | Siemens Healthcare Diagnostics, Inc. |
| 2018-06-13 | Z-2055-2018 | Class II | BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3 | Becton Dickinson & Company |
| 2018-06-13 | Z-2056-2018 | Class II | BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5 | Becton Dickinson & Company |
| 2018-06-13 | Z-2057-2018 | Class II | 3910-090-800 ASSY | Stryker Corporation |
| 2018-06-13 | Z-2059-2018 | Class II | RX Imola | Randox Laboratories |
| 2018-06-13 | Z-2061-2018 | Class II | nordicICE v 2 | NordicNeuroLab AS |
| 2018-06-13 | Z-2062-2018 | Class II | ADVIA Chemistry Urea Nitrogen Reagent | Siemens Healthcare Diagnostics, Inc. |
| 2018-06-13 | Z-2063-2018 | Class II | TL-HEX TruLok Hexapod System | Orthofix Srl |
| 2018-06-13 | Z-2064-2018 | Class II | Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter | C.R. Bard, Inc. |
| 2018-06-13 | Z-2065-2018 | Class II | ST-AIA PACK AFP | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2066-2018 | Class II | ST-AIA PACK CEA | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2067-2018 | Class II | ST-AIA PACK PA | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2068-2018 | Class II | ST-AIA PACK PAP | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2069-2018 | Class II | ST-AIA PACK CA 19-9 | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2070-2018 | Class II | ST-AIA PACK 27 | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2071-2018 | Class II | ST-AIA PACK CK-MB | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2072-2018 | Class II | ST-AIA PACK Myoglobin | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2073-2018 | Class II | ST-AIA PACK cTnI 2nd Gen | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2074-2018 | Class II | ST-AIA PACK C-Peptide | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2075-2018 | Class II | ST-AIA PACK C-Peptide II | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2076-2018 | Class II | ST-AIA PACK IRI | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2077-2018 | Class II | AIA-PACK TSH 3rd Generation | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2078-2018 | Class II | ST-AIA PACK TT3 | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2079-2018 | Class II | ST-AIA PACK T4 | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2080-2018 | Class II | ST-AIA PACK FT3 | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2081-2018 | Class II | ST-AIA PACK FT4 | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2082-2018 | Class II | ST-AIA PACK TU | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2083-2018 | Class II | ST-AIA PACK ¿HCG | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2084-2018 | Class II | ST-AIA PACK HCG | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2085-2018 | Class II | ST-AIA DHEA-S | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2086-2018 | Class II | ST-AIA PACK FSH | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2087-2018 | Class II | ST-AIA PACK Prolactin | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2088-2018 | Class II | ST-AIA PACK Estradiol | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2089-2018 | Class II | ST-AIA PACK hsE2 | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2090-2018 | Class II | ST-AIA PACK LH II | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2091-2018 | Class II | ST-AIA PACK Prog II | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2092-2018 | Class II | ST-AIA PACK SHBG | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2093-2018 | Class II | ST-AIA PACK Testosterone | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2094-2018 | Class II | ST-AIA PACK Cort | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2095-2018 | Class II | ST-AIA PACK HGH | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2096-2018 | Class II | ST-AIA PACK Fer | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2097-2018 | Class II | ST-AIA PACK IGE II | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2098-2018 | Class II | ST-AIA PACK BMG | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2099-2018 | Class II | ST-AIA PACK Cystatin C | Tosoh Bioscience Inc |
| 2018-06-13 | Z-2100-2018 | Class II | VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit | VGI Medical, LLC |
| 2018-06-13 | Z-2101-2018 | Class II | Centricity PACS-IW with Universal Viewer Product Usage: Usage:… | GE Healthcare |
| 2018-06-13 | Z-2102-2018 | Class II | Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW… | GE Healthcare |
| 2018-06-13 | Z-2103-2018 | Class II | fMRI Hardware System | NordicNeuroLab AS |
| 2018-06-13 | Z-2104-2018 | Class III | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET | Datascope Corporation |
| 2018-06-13 | Z-2105-2018 | Class III | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801… | Datascope Corporation |
| 2018-06-13 | Z-2106-2018 | Class III | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack… | Datascope Corporation |
| 2018-06-13 | Z-2107-2018 | Class II | MicroAire SmartRelease Endoscopic System | MicroAire Surgical Instruments, LLC |
| 2018-06-13 | Z-2108-2018 | Class II | ROSA | MEDTECH SAS |
| 2018-06-13 | Z-2109-2018 | Class II | 12C | Ion Beam Applications S.A. |
| 2018-06-13 | Z-2110-2018 | Class II | NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis | Fresenius Medical Care Renal Therapies Group, LLC |
| 2018-06-13 | Z-2111-2018 | Class II | Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is… | CareFusion 303, Inc. |
| 2018-06-13 | Z-2112-2018 | Class II | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation |
| 2018-06-13 | Z-2113-2018 | Class II | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation |
| 2018-06-13 | Z-2114-2018 | Class II | Bivona¿ Tracheostomy Tube Tracheostomy Tubes | Smiths Medical ASD Inc. |
| 2018-06-13 | Z-2115-2018 | Class II | Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio… | Invivo Corporation |
| 2018-06-13 | Z-2116-2018 | Class II | Rival Reduce Kit Locking and Non-Locking Screw D 2 | Orthofix, Inc |
| 2018-06-13 | Z-2117-2018 | Class II | Rival View Kit Locking and Non-Locking Screw D 2 | Orthofix, Inc |