| Reported | Recall | Class | Product | Firm |
|---|
| 2014-09-10 | Z-2457-2014 | Class I | CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free | Customed, Inc |
| 2014-09-10 | Z-2458-2014 | Class I | KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: | Customed, Inc |
| 2014-09-10 | Z-2459-2014 | Class I | 08 PAD PACK II | Customed, Inc |
| 2014-09-10 | Z-2460-2014 | Class I | BASIC PACK IV | Customed, Inc |
| 2014-09-10 | Z-2461-2014 | Class I | BASIC PACK 1 | Customed, Inc |
| 2014-09-10 | Z-2462-2014 | Class I | ARTHROSCOPY PACK I | Customed, Inc |
| 2014-09-10 | Z-2463-2014 | Class I | C | Customed, Inc |
| 2014-09-10 | Z-2464-2014 | Class I | MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: | Customed, Inc |
| 2014-09-10 | Z-2465-2014 | Class I | CYSTOSCOPY PACK Ill | Customed, Inc |
| 2014-09-10 | Z-2466-2014 | Class I | LAPAROSCOPY ABO PACK | Customed, Inc |
| 2014-09-10 | Z-2467-2014 | Class I | LAPAROSCOPY PACK I | Customed, Inc |
| 2014-09-10 | Z-2468-2014 | Class I | LAPAROTOMY PACK 1 | Customed, Inc |
| 2014-09-10 | Z-2469-2014 | Class I | TRANSVERSE LAPAROTOMY PACK | Customed, Inc |
| 2014-09-10 | Z-2470-2014 | Class I | LAPAROTOMY PACK Ill | Customed, Inc |
| 2014-09-10 | Z-2471-2014 | Class I | EENT PACK I CUSTOMED CONTENT: | Customed, Inc |
| 2014-09-10 | Z-2472-2014 | Class I | ORTHOPEDIC PACK I | Customed, Inc |
| 2014-09-10 | Z-2473-2014 | Class I | ORTHOPEDIC PACK Ill | Customed, Inc |
| 2014-09-10 | Z-2474-2014 | Class I | Urology Pack | Customed, Inc |
| 2014-09-10 | Z-2475-2014 | Class I | Minor Pack 900-2511 | Customed, Inc |
| 2014-09-10 | Z-2476-2014 | Class I | Laparotomy Pack | Customed, Inc |
| 2014-09-10 | Z-2477-2014 | Class I | Gown Cool Impervious XLGE Breathable Customed | Customed, Inc |
| 2014-09-10 | Z-2478-2014 | Class I | Arthroscopy Pack | Customed, Inc |
| 2014-09-10 | Z-2479-2014 | Class I | Hip & Knee replacement pack | Customed, Inc |
| 2014-09-10 | Z-2480-2014 | Class I | Extremity Pack | Customed, Inc |
| 2014-09-10 | Z-2481-2014 | Class I | Shoulder Pack | Customed, Inc |
| 2014-09-10 | Z-2482-2014 | Class I | Open Heart Pack | Customed, Inc |
| 2014-09-10 | Z-2483-2014 | Class I | LAP Abdom w/pouch Customed code 900-2619 | Customed, Inc |
| 2014-09-10 | Z-2484-2014 | Class I | HIP PACK I | Customed, Inc |
| 2014-09-10 | Z-2485-2014 | Class I | Universal Pack II | Customed, Inc |
| 2014-09-10 | Z-2486-2014 | Class I | Shoulder pack | Customed, Inc |
| 2014-09-10 | Z-2487-2014 | Class I | Plastic Pack Customed | Customed, Inc |
| 2014-09-10 | Z-2488-2014 | Class I | Face Pack MRT | Customed, Inc |
| 2014-09-10 | Z-2489-2014 | Class I | Liposuction Pack MRT | Customed, Inc |
| 2014-09-10 | Z-2490-2014 | Class I | Tummy Pack MRT | Customed, Inc |
| 2014-09-10 | Z-2491-2014 | Class I | Breast Pack MRT | Customed, Inc |
| 2014-09-10 | Z-2492-2014 | Class I | Breast Implant Pack | Customed, Inc |
| 2014-09-10 | Z-2493-2014 | Class I | Tummy Tuck and Liposuction Pack | Customed, Inc |
| 2014-09-10 | Z-2494-2014 | Class I | Liposuction Pack | Customed, Inc |
| 2014-09-10 | Z-2495-2014 | Class I | Breast Augmentation Pack | Customed, Inc |
| 2014-09-10 | Z-2496-2014 | Class I | Tummy Tuck Pack | Customed, Inc |
| 2014-09-10 | Z-2497-2014 | Class I | Bandeja para Debridacion | Customed, Inc |
| 2014-09-10 | Z-2498-2014 | Class I | Endovascular Pack | Customed, Inc |
| 2014-09-10 | Z-2499-2014 | Class I | Knee Arthroscopy Pack | Customed, Inc |
| 2014-09-10 | Z-2500-2014 | Class I | Shoulder Arthroscopy Pack | Customed, Inc |
| 2014-09-10 | Z-2501-2014 | Class I | Gown Surgical Soft SMS Non Reinforced | Customed, Inc |
| 2014-09-10 | Z-2502-2014 | Class I | REEMPLAZO DE RODILLA Y CADERA CONTENTS: | Customed, Inc |
| 2014-09-10 | Z-2503-2014 | Class I | MINOR PACK CONTENTS: | Customed, Inc |
| 2014-09-10 | Z-2504-2014 | Class I | NEURO SPINE PACK | Customed, Inc |
| 2014-09-10 | Z-2505-2014 | Class I | SHOULDER PACK CODE 900-2766 CONTENTS: | Customed, Inc |
| 2014-09-10 | Z-2506-2014 | Class I | LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: | Customed, Inc |
| 2014-09-10 | Z-2507-2014 | Class I | ORTHOPEDIC PACK BASIC CODE 900-2830 | Customed, Inc |
| 2014-09-10 | Z-2508-2014 | Class I | CYSTO TUR PACK BASIC CODE 900-2899 | Customed, Inc |
| 2014-09-10 | Z-2509-2014 | Class I | ORTHOPEDIC IMPLANT PACK CUSTOMED USA | Customed, Inc |
| 2014-09-10 | Z-2510-2014 | Class I | BASIC COSMETIC SURG | Customed, Inc |
| 2014-09-10 | Z-2511-2014 | Class I | ACDFPACK SURGICAL CENTER | Customed, Inc |
| 2014-09-10 | Z-2512-2014 | Class I | TLIF PACK SURGICAL CENTER | Customed, Inc |
| 2014-09-10 | Z-2513-2014 | Class I | Obstetrical Surgical pack | Customed, Inc |
| 2014-09-10 | Z-2514-2014 | Class I | Drape Sheet | Customed, Inc |
| 2014-09-10 | Z-2515-2014 | Class I | Hair Restoration Pack- | Customed, Inc |
| 2014-09-10 | Z-2516-2014 | Class I | Basic Pack FPSC Florham Pack | Customed, Inc |
| 2014-09-10 | Z-2517-2014 | Class I | Chole Cystectomy All Endo System | Customed, Inc |
| 2014-09-10 | Z-2518-2014 | Class I | Tummy Tuck Pack-BOD | Customed, Inc |
| 2014-09-10 | Z-2519-2014 | Class I | Face Pack- BOD | Customed, Inc |
| 2014-09-10 | Z-2520-2014 | Class I | Liposuction Pack BOD | Customed, Inc |
| 2014-09-10 | Z-2521-2014 | Class I | Breast Pack BOD | Customed, Inc |
| 2014-09-10 | Z-2522-2014 | Class I | Face Lift | Customed, Inc |
| 2014-09-10 | Z-2523-2014 | Class I | General Cosmetic Pack FCSC | Customed, Inc |
| 2014-09-10 | Z-2524-2014 | Class I | Tummy Tuck Pack- FJG | Customed, Inc |
| 2014-09-10 | Z-2525-2014 | Class I | Liposuction Pack FJG | Customed, Inc |
| 2014-09-10 | Z-2526-2014 | Class I | Face Pack FJG | Customed, Inc |
| 2014-09-10 | Z-2527-2014 | Class I | Breast Pack- FJG | Customed, Inc |
| 2014-09-10 | Z-2528-2014 | Class I | Laparoscopy pack | Customed, Inc |
| 2014-09-10 | Z-2529-2014 | Class I | Gown Impervious | Customed, Inc |
| 2014-09-10 | Z-2530-2014 | Class I | Breast pack TPSC | Customed, Inc |
| 2014-09-10 | Z-2531-2014 | Class I | Open Heart Tray | Customed, Inc |
| 2014-09-10 | Z-2532-2014 | Class I | Cirugia Cardiovascular Case Cart | Customed, Inc |
| 2014-09-10 | Z-2533-2014 | Class I | LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A | Customed, Inc |
| 2014-09-10 | Z-2534-2014 | Class I | Lithotomy Pack III | Customed, Inc |
| 2014-09-10 | Z-2560-2014 | Class II | ACL Sleeve Installation Tool Sizes: 6mm | OrthoPediatrics Corp |
| 2014-09-10 | Z-2561-2014 | Class II | Siemens EasyLink Informatics System V4 | Siemens Healthcare Diagnostics, Inc. |
| 2014-09-10 | Z-2562-2014 | Class II | Affinity¿ Four Birthing Bed | Hill-Rom, Inc. |
| 2014-09-10 | Z-2563-2014 | Class II | Roche cobas IT 1000 Product Usage: Intended Use: An electronic device… | Roche Diagnostics Operations, Inc. |
| 2014-09-10 | Z-2564-2014 | Class II | Hitachi Echelon Oval MRI system is a diagnostic imaging device | Hitachi Medical Systems America Inc |
| 2014-09-10 | Z-2565-2014 | Class II | Medsolutions4U Multi-Function Electrodes to be used with… | Bio-Detek, Inc. |
| 2014-09-10 | Z-2566-2014 | Class II | Biomet Microfixation Temporomandibular Joint | Biomet Microfixation, LLC |
| 2014-09-10 | Z-2568-2014 | Class III | LINEAR 7 | Datascope Corporation |
| 2014-09-10 | Z-2571-2014 | Class II | V5Ms Transesophageal transducers | Siemens Medical Solutions USA, Inc. |
| 2014-09-10 | Z-2572-2014 | Class II | Ellipse Implantable Cardioverter Defibrillators | St Jude Medical Cardiac Rhythm Management Division |
| 2014-09-10 | Z-2573-2014 | Class II | STREAMLINE CT CERVICO-THORACIC SYSTEM | PIONEER SURGICAL TECHNOLOGY, INC. |
| 2014-09-10 | Z-2574-2014 | Class II | FOCAL Sim Workstation | Elekta, Inc. |
| 2014-09-10 | Z-2575-2014 | Class II | PERSONA The Personalized Knee System Constrained Tibial Articular… | Zimmer, Inc. |
| 2014-09-10 | Z-2576-2014 | Class II | PERSONA The Personalized Knee System Constrained Posterior Stabilized… | Zimmer, Inc. |
| 2014-09-10 | Z-2577-2014 | Class II | PERSONA The Personalized Knee System CR Tibial Articular Surface… | Zimmer, Inc. |
| 2014-09-10 | Z-2578-2014 | Class II | PERSONA The Personalized Knee System Tibial Articular Surface… | Zimmer, Inc. |
| 2014-09-10 | Z-2579-2014 | Class II | PERSONA The Personalized Knee System PS Tibial Articular Surface… | Zimmer, Inc. |
| 2014-09-10 | Z-2580-2014 | Class II | PERSONA" The Personalized Knee System UC Tibial Articular Surface… | Zimmer, Inc. |
| 2014-09-10 | Z-2581-2014 | Class II | Monaco The Monaco system is used to make treatment plans for patients… | Elekta, Inc. |
| 2014-09-10 | Z-2582-2014 | Class II | Natural-Knee System Patella Bushings | Zimmer, Inc. |
| 2014-09-10 | Z-2583-2014 | Class II | Natural-Knee System Patella Bushings | Zimmer, Inc. |
| 2014-09-10 | Z-2584-2014 | Class II | Natural-Knee System Patella Bushings Orthopedic surgical instrument | Zimmer, Inc. |
| 2014-09-10 | Z-2585-2014 | Class II | Natural-Knee System Patella Bushings Orthopedic surgical instrument | Zimmer, Inc. |
| 2014-09-10 | Z-2586-2014 | Class II | ARIATELE TELEMETRY TRANSMITTER | Spacelabs Healthcare Inc |
| 2014-09-10 | Z-2588-2014 | Class II | GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE… | Galt Medical Corporation |
| 2014-09-10 | Z-2589-2014 | Class II | GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex | Galt Medical Corporation |
| 2014-09-10 | Z-2590-2014 | Class II | iTRACK250A Canaloplasty Microcatheter Kit | Ellex iScience, Inc. |
| 2014-09-10 | Z-2591-2014 | Class II | EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer… | Mentor Texas, LP. |
| 2014-09-10 | Z-2592-2014 | Class II | Split Cath III Trays | Medical Components, Inc dba MedComp |
| 2014-09-03 | Z-2243-2014 | Class I | CloverSnare 4-Loop Vascular Retrieval Snare | Cook Inc. |
| 2014-09-03 | Z-2536-2014 | Class I | 4001PS Neonatal/Paed | Smiths Medical ASD, Inc. |
| 2014-09-03 | Z-2537-2014 | Class I | H4001S Neonatal/Paed | Smiths Medical ASD, Inc. |
| 2014-09-03 | Z-2538-2014 | Class I | H4002PS Neonatal/Paed | Smiths Medical ASD, Inc. |
| 2014-09-03 | Z-2539-2014 | Class I | H4002S Neonatal/Paed | Smiths Medical ASD, Inc. |
| 2014-09-03 | Z-2540-2014 | Class I | H4051 Endo Tube Holder | Smiths Medical ASD, Inc. |
| 2014-09-03 | Z-2541-2014 | Class I | H4052 Endo Tube Holder | Smiths Medical ASD, Inc. |
| 2014-09-03 | Z-2542-2014 | Class II | BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin | Becton Dickinson & Company |
| 2014-09-03 | Z-2543-2014 | Class II | Zimmer PERSONA Distal Valgus Alignment Guide | Zimmer, Inc. |
| 2014-09-03 | Z-2544-2014 | Class II | Medtronic MiniMed Paradigm Insulin Infusion Pumps | Medtronic MiniMed Inc. |
| 2014-09-03 | Z-2545-2014 | Class II | Zimmer Gender Solution Patello-Femoral Joint | Zimmer, Inc. |
| 2014-09-03 | Z-2546-2014 | Class II | Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS… | Zimmer, Inc. |
| 2014-09-03 | Z-2547-2014 | Class II | Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO… | Zimmer, Inc. |
| 2014-09-03 | Z-2548-2014 | Class II | Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA | Zimmer, Inc. |
| 2014-09-03 | Z-2549-2014 | Class II | Trauma Large Screws: CANN BONE SCREW 7 | Zimmer, Inc. |
| 2014-09-03 | Z-2550-2014 | Class II | Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT… | Zimmer, Inc. |
| 2014-09-03 | Z-2551-2014 | Class II | Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP… | Zimmer, Inc. |
| 2014-09-03 | Z-2552-2014 | Class II | Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM… | Zimmer, Inc. |
| 2014-09-03 | Z-2553-2014 | Class II | Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic… | Siemens Healthcare Diagnostics, Inc. |
| 2014-09-03 | Z-2554-2014 | Class II | CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor | Curbell Medical, Inc. |
| 2014-09-03 | Z-2555-2014 | Class II | The Thermedx Fluid Management System is designed to provide… | Thermedx LLC |
| 2014-09-03 | Z-2556-2014 | Class II | Cordis EMPIRA NC RX PTCA Dilatation Catheter | Cordis Corporation |
| 2014-09-03 | Z-2557-2014 | Class II | Cordis EMPIRA RX PTCA Dilatation Catheter | Cordis Corporation |
| 2014-09-03 | Z-2558-2014 | Class II | CollectEVAC | Civco Medical Instruments Inc |
| 2014-09-03 | Z-2559-2014 | Class III | Verigene CYP2C19 Nucleic Acid Test | Nanosphere, Inc. |
| 2014-08-27 | Z-2148-2014 | Class I | DePuy Synthes Craniomaxillofacial Distraction System | Synthes, Inc. |
| 2014-08-27 | Z-2192-2014 | Class I | Gel-E Donut | Childrens Medical Ventures |
| 2014-08-27 | Z-2238-2014 | Class II | Siemens Dimension Chemistry Wash | Siemens Healthcare Diagnostics, Inc. |
| 2014-08-27 | Z-2239-2014 | Class II | TomoTherapy Treatment System | TomoTherapy Incorporated |
| 2014-08-27 | Z-2240-2014 | Class II | TomoTherapy Treatment System | TomoTherapy Incorporated |
| 2014-08-27 | Z-2241-2014 | Class II | Apex Arc Hip Stem | Omnilife Science Inc. |
| 2014-08-27 | Z-2242-2014 | Class II | Vanguard 360 Femoral Boss Reamer | Biomet, Inc. |
| 2014-08-27 | Z-2244-2014 | Class II | Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded… | Zimmer, Inc. |
| 2014-08-27 | Z-2245-2014 | Class II | Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw… | Zimmer, Inc. |
| 2014-08-27 | Z-2246-2014 | Class II | 6 | Zimmer, Inc. |
| 2014-08-27 | Z-2247-2014 | Class II | 6 | Zimmer, Inc. |
| 2014-08-27 | Z-2248-2014 | Class II | 6 | Zimmer, Inc. |
| 2014-08-27 | Z-2249-2014 | Class II | 6 | Zimmer, Inc. |
| 2014-08-27 | Z-2250-2014 | Class II | 4 | Zimmer, Inc. |
| 2014-08-27 | Z-2251-2014 | Class II | 4 | Zimmer, Inc. |
| 2014-08-27 | Z-2252-2014 | Class II | Philips IntelliSpace PACS 4 | Philips Healthcare Informatics, Inc. |
| 2014-08-27 | Z-2253-2014 | Class II | Pivot Bipolar Cup 22x42/43-51/53mm | Ortho Development Corporation |
| 2014-08-27 | Z-2254-2014 | Class II | Patella 38mm | Ortho Development Corporation |
| 2014-08-27 | Z-2255-2014 | Class II | PS Tibial Insert | Ortho Development Corporation |
| 2014-08-27 | Z-2256-2014 | Class II | Tibila Insert UC | Ortho Development Corporation |
| 2014-08-27 | Z-2257-2014 | Class II | Tibila Insert CK | Ortho Development Corporation |
| 2014-08-27 | Z-2258-2014 | Class II | TRIGEN | Smith & Nephew, Inc. |
| 2014-08-27 | Z-2259-2014 | Class II | Medtronic | Medtronic Neuromodulation |
| 2014-08-27 | Z-2260-2014 | Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE | Angiodynamics, Inc. |
| 2014-08-27 | Z-2261-2014 | Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE | Angiodynamics, Inc. |
| 2014-08-27 | Z-2262-2014 | Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE | Angiodynamics, Inc. |
| 2014-08-27 | Z-2263-2014 | Class II | WaterLase iPlus Dental Laser System | Biolase Technology Inc |
| 2014-08-27 | Z-2264-2014 | Class II | All brochures printed before November 20 | Hyperion Medical |
| 2014-08-27 | Z-2265-2014 | Class II | Synthes 3 | Synthes, Inc. |
| 2014-08-27 | Z-2266-2014 | Class II | Gelweave | Vascutek, Ltd. |
| 2014-08-27 | Z-2267-2014 | Class II | IntelePACS software versions 3-8-1 to 4-9-1 | Intelerad Medical Systems |
| 2014-08-27 | Z-2268-2014 | Class II | Blood pressure | Ansar Group, Inc. Dba Ansar Medical Technologies, Inc |
| 2014-08-27 | Z-2269-2014 | Class II | Gyrus ACMI Falope-Ring Dilator | Gyrus Medical, Inc |
| 2014-08-27 | Z-2270-2014 | Class II | Philips IP5 Information Portal The Expression Information Portal | Invivo Corporation |
| 2014-08-27 | Z-2271-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2272-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2273-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2274-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2275-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2276-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2277-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2278-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2279-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2280-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2281-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2282-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2283-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2284-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2285-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2286-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2287-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design | AMO Puerto Rico Manufacturing, Inc. |
| 2014-08-27 | Z-2288-2014 | Class II | PERSONA | Zimmer, Inc. |
| 2014-08-27 | Z-2289-2014 | Class II | PERSONA | Zimmer, Inc. |
| 2014-08-27 | Z-2290-2014 | Class II | PENTAX Upper/Lower G | Pentax Medical Company |
| 2014-08-27 | Z-2291-2014 | Class II | GE Healthcare | GE Healthcare, LLC |
| 2014-08-27 | Z-2293-2014 | Class II | CAP Change Kit w/MicroClave Clear | ICU Medical, Inc. |
| 2014-08-27 | Z-2294-2014 | Class II | Cap Change Kit with MicroClave Clear Connector | ICU Medical, Inc. |
| 2014-08-27 | Z-2295-2014 | Class II | Port Access Kit with MicroClave Clear Connector | ICU Medical, Inc. |
| 2014-08-27 | Z-2296-2014 | Class II | Persona | Zimmer, Inc. |
| 2014-08-27 | Z-2297-2014 | Class II | Persona | Zimmer, Inc. |
| 2014-08-27 | Z-2298-2014 | Class II | Persona | Zimmer, Inc. |
| 2014-08-27 | Z-2299-2014 | Class II | Persona | Zimmer, Inc. |
| 2014-08-27 | Z-2300-2014 | Class II | Persona | Zimmer, Inc. |
| 2014-08-27 | Z-2301-2014 | Class II | Persona | Zimmer, Inc. |
| 2014-08-27 | Z-2535-2014 | Class II | Philips IntelliSpace ECG Management System | Philips Medical Systems, Inc. |
| 2014-08-20 | Z-2120-2014 | Class II | GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser… | Nidek Inc |
| 2014-08-20 | Z-2135-2014 | Class I | Enhancement Medical expression | Enhancement Medical, LLC |
| 2014-08-20 | Z-2155-2014 | Class I | CSI Cardiovascular Systems | Cardiovascular Systems, Inc. |