Medical device recalls reported in 2016

← Newer · Older →

Reported	Recall	Class	Product	Firm
2016-11-23	Z-0510-2017	Class II	BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY	ICU Medical, Inc.
2016-11-23	Z-0511-2017	Class II	TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY	ICU Medical, Inc.
2016-11-23	Z-0512-2017	Class II	MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR	ICU Medical, Inc.
2016-11-23	Z-0513-2017	Class II	QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST	ICU Medical, Inc.
2016-11-23	Z-0514-2017	Class II	MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP	ICU Medical, Inc.
2016-11-23	Z-0515-2017	Class II	Neonate Kit With 30 ml Flush Device For Driscoll Foundation For…	ICU Medical, Inc.
2016-11-23	Z-0516-2017	Class II	Cath Lab Kit w/3 Port "ON" Manifold	ICU Medical, Inc.
2016-11-23	Z-0517-2017	Class II	PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP	ICU Medical, Inc.
2016-11-23	Z-0518-2017	Class II	CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP	ICU Medical, Inc.
2016-11-23	Z-0519-2017	Class II	CATH LAB KIT	ICU Medical, Inc.
2016-11-23	Z-0520-2017	Class II	CATH LAB KIT w/3 PORT ''ON'' MANIFOLD	ICU Medical, Inc.
2016-11-23	Z-0521-2017	Class II	SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG	ICU Medical, Inc.
2016-11-23	Z-0522-2017	Class II	PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED	ICU Medical, Inc.
2016-11-23	Z-0523-2017	Class II	QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP	ICU Medical, Inc.
2016-11-23	Z-0524-2017	Class II	TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV	ICU Medical, Inc.
2016-11-23	Z-0525-2017	Class II	TRANSDUCER KIT FOR MEDICAL CTR	ICU Medical, Inc.
2016-11-23	Z-0526-2017	Class II	TRIPLE	ICU Medical, Inc.
2016-11-23	Z-0527-2017	Class II	SINGLE	ICU Medical, Inc.
2016-11-23	Z-0528-2017	Class II	Cath Lab Kit w/Waste Bag	ICU Medical, Inc.
2016-11-23	Z-0529-2017	Class II	Cath Lab Kit w/03 ml Intraflo	ICU Medical, Inc.
2016-11-23	Z-0530-2017	Class II	CATH LAB KIT w/3 PORT "OFF" MANIFOLD	ICU Medical, Inc.
2016-11-23	Z-0531-2017	Class II	CATH LAB KIT w/4 PORT "ON" MANIFOLD	ICU Medical, Inc.
2016-11-23	Z-0532-2017	Class II	4 PORT "OFF" MANIFOLD	ICU Medical, Inc.
2016-11-23	Z-0533-2017	Class II	2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT	ICU Medical, Inc.
2016-11-23	Z-0534-2017	Class II	Cath Lab Kit w/03 ml Squeeze Flush	ICU Medical, Inc.
2016-11-23	Z-0535-2017	Class II	DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET	ICU Medical, Inc.
2016-11-23	Z-0536-2017	Class II	Quad Kit W/03ML Flush Device	ICU Medical, Inc.
2016-11-23	Z-0537-2017	Class II	CARDIAC KIT WITH 03 ml FLUSH DEVICE	ICU Medical, Inc.
2016-11-23	Z-0538-2017	Class II	Transpac¿ 4 kit w/72" Macrodrip¿ Admin Set	ICU Medical, Inc.
2016-11-23	Z-0539-2017	Class II	5 Port "OFF" Manifold w/TRANSPAC¿ IV	ICU Medical, Inc.
2016-11-23	Z-0540-2017	Class II	Cath Lab Kit w/Waste Bag System	ICU Medical, Inc.
2016-11-23	Z-0541-2017	Class II	Right Heart Cath Lab Kit w/2 Port "OFF" Manifold	ICU Medical, Inc.
2016-11-23	Z-0542-2017	Class II	TP4 Monitoring Kit w/84" Safeset" Reservoir	ICU Medical, Inc.
2016-11-23	Z-0543-2017	Class II	Trifurcated Monitoring Kit w/84" Safeset" Reservoir	ICU Medical, Inc.
2016-11-23	Z-0544-2017	Class II	Transpac¿ w/Safeset Reservoir	ICU Medical, Inc.
2016-11-23	Z-0545-2017	Class II	TRANSPAC¿ IV TRIFURCATED MONITORING KIT 72"	ICU Medical, Inc.
2016-11-23	Z-0546-2017	Class II	Transpac¿ IV Monitoring Kit w/ Safeset Reservoir	ICU Medical, Inc.
2016-11-23	Z-0547-2017	Class II	Transpac¿ IV Monitoring Kit w/Safeset 72" Pressure Tubing	ICU Medical, Inc.
2016-11-23	Z-0548-2017	Class II	Monitoring Kit w/TP4	ICU Medical, Inc.
2016-11-23	Z-0549-2017	Class II	TRANSPAC¿ IV MONITORING KIT	ICU Medical, Inc.
2016-11-23	Z-0550-2017	Class II	Transpac¿ IV Monitoring Kit	ICU Medical, Inc.
2016-11-23	Z-0551-2017	Class II	TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT	ICU Medical, Inc.
2016-11-23	Z-0552-2017	Class II	Transpac¿ IV Monitoring Kit	ICU Medical, Inc.
2016-11-23	Z-0553-2017	Class II	Transpac¿ IV Monitoring Kit w/Safeset 84" Arterial Pressure Tubing	ICU Medical, Inc.
2016-11-23	Z-0554-2017	Class II	Monitoring Kit w/TP4	ICU Medical, Inc.
2016-11-23	Z-0555-2017	Class II	Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip	ICU Medical, Inc.
2016-11-23	Z-0556-2017	Class II	Bifurcated Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device	ICU Medical, Inc.
2016-11-23	Z-0557-2017	Class II	Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device	ICU Medical, Inc.
2016-11-23	Z-0558-2017	Class II	Transpac¿ IV Monitoring Kit w/Safeset" Blood Sampling Port and 03 ml…	ICU Medical, Inc.
2016-11-23	Z-0559-2017	Class II	Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device	ICU Medical, Inc.
2016-11-23	Z-0560-2017	Class II	Transpac¿ IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device	ICU Medical, Inc.
2016-11-23	Z-0561-2017	Class II	Transpac¿ IV Monitoring Kit	ICU Medical, Inc.
2016-11-23	Z-0562-2017	Class II	Transpac¿ IV Monitoring Kit w/Arterial 84" Safeset" Reservoir	ICU Medical, Inc.
2016-11-23	Z-0563-2017	Class II	Transpac¿ IV Disposable Transducer w/Stopcocks w/o Cap and Covers	ICU Medical, Inc.
2016-11-23	Z-0564-2017	Class II	Transpac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG	ICU Medical, Inc.
2016-11-23	Z-0565-2017	Class II	Transpac¿ IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir	ICU Medical, Inc.
2016-11-23	Z-0566-2017	Class II	Transpac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush…	ICU Medical, Inc.
2016-11-23	Z-0567-2017	Class II	Transpac¿ IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze…	ICU Medical, Inc.
2016-11-23	Z-0568-2017	Class II	Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling…	ICU Medical, Inc.
2016-11-23	Z-0569-2017	Class II	Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device	ICU Medical, Inc.
2016-11-23	Z-0570-2017	Class II	Cath Lab Kit w/3 Port "ON" Manifold	ICU Medical, Inc.
2016-11-23	Z-0571-2017	Class II	Cath Lab Left Heart Kit w/3 Port Manifold "OFF"	ICU Medical, Inc.
2016-11-23	Z-0572-2017	Class II	4 Port "ON" Manifold	ICU Medical, Inc.
2016-11-23	Z-0573-2017	Class II	Expression MR IBP DPT Kit	ICU Medical, Inc.
2016-11-23	Z-0574-2017	Class II	CATH LAB KIT W/3 PORT "ON" MANIFOLD	ICU Medical, Inc.
2016-11-23	Z-0575-2017	Class II	LEFT HEART KIT	ICU Medical, Inc.
2016-11-23	Z-0576-2017	Class II	Atrium Medical 8 Fr Trocar catheter	Atrium Medical Corporation
2016-11-23	Z-0577-2017	Class II	Atrium Medical 10 Fr Trocar catheter	Atrium Medical Corporation
2016-11-23	Z-0578-2017	Class II	Atrium Medical 12 Fr Trocar catheter	Atrium Medical Corporation
2016-11-23	Z-0579-2017	Class II	Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to…	Atrium Medical Corporation
2016-11-23	Z-0580-2017	Class II	Atrium Medical 20 Fr Trocar catheter	Atrium Medical Corporation
2016-11-23	Z-0581-2017	Class II	Atrium Medical 24 Fr Trocar catheter	Atrium Medical Corporation
2016-11-23	Z-0582-2017	Class II	Atrium Medical 28 Fr Trocar catheter	Atrium Medical Corporation
2016-11-23	Z-0583-2017	Class II	Atrium Medical 32 Fr Trocar catheter	Atrium Medical Corporation
2016-11-23	Z-0584-2017	Class III	RF MultiGen¿	Stryker Instruments Div. of Stryker Corporation
2016-11-23	Z-0585-2017	Class II	C-Max" Cutting Loop Electrodes	C.R. Bard, Inc.
2016-11-23	Z-0586-2017	Class II	Version 1	Roche Diabetes Care, Inc.
2016-11-23	Z-0587-2017	Class II	FlexLab	Inpeco S.A.
2016-11-23	Z-0588-2017	Class II	Alere Triage Total 5 Control Level 1	Alere San Diego, Inc.
2016-11-23	Z-0589-2017	Class II	Advia Chemistry Calibrator For in vitro diagnostic use in the…	Siemens Healthcare Diagnostics, Inc.
2016-11-23	Z-0590-2017	Class II	Aptio Automation Modules	Siemens Healthcare Diagnostics, Inc.
2016-11-23	Z-0591-2017	Class II	FlexLab Automation Modules	Siemens Healthcare Diagnostics, Inc.
2016-11-23	Z-0592-2017	Class II	Arsenal Spinal Fixation System	Alphatec Spine, Inc.
2016-11-23	Z-0593-2017	Class III	Brilliance iCT Computed Tomography X-ray system	Philips Medical Systems (Cleveland) Inc
2016-11-23	Z-0594-2017	Class III	Brilliance ICT SP Computed Tomography X-ray system	Philips Medical Systems (Cleveland) Inc
2016-11-23	Z-0595-2017	Class III	Ingenuity CT Computed Tomography X-ray system	Philips Medical Systems (Cleveland) Inc
2016-11-23	Z-0596-2017	Class III	Ingenuity Core 128 Computed Tomography X-ray system	Philips Medical Systems (Cleveland) Inc
2016-11-23	Z-0597-2017	Class III	Ingenuity Core Computed Tomography X-ray system	Philips Medical Systems (Cleveland) Inc
2016-11-23	Z-0598-2017	Class III	IQon Spectral CT Computed Tomography X-ray system	Philips Medical Systems (Cleveland) Inc
2016-11-23	Z-0599-2017	Class II	Merge PACS software	Merge Healthcare, Inc.
2016-11-23	Z-0600-2017	Class II	Magic3 Antibacterial Hydrophilic Intermittent Catheter	C.R. Bard, Inc.
2016-11-23	Z-0601-2017	Class II	Artis Q	Siemens Medical Solutions USA, Inc
2016-11-23	Z-0602-2017	Class II	Artis zee/zeego	Siemens Medical Solutions USA, Inc
2016-11-23	Z-0603-2017	Class II	AXIOM Artis	Siemens Medical Solutions USA, Inc
2016-11-23	Z-0604-2017	Class II	SOMATOM Definition AS	Siemens Medical Solutions USA, Inc
2016-11-23	Z-0605-2017	Class II	SOMATOM Definition Flash	Siemens Medical Solutions USA, Inc
2016-11-23	Z-0606-2017	Class II	SOMATOM Definition AS	Siemens Medical Solutions USA, Inc
2016-11-23	Z-0607-2017	Class II	SOMATOM Definition Edge	Siemens Medical Solutions USA, Inc
2016-11-23	Z-0608-2017	Class II	SOMATOM Definition Flash	Siemens Medical Solutions USA, Inc
2016-11-23	Z-0609-2017	Class II	Model 208-70-110	Trilliant Surgical Ltd.
2016-11-23	Z-0610-2017	Class III	OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS…	OMNI LIFE SCIENCE
2016-11-23	Z-0611-2017	Class II	iConnect Access software	Merge Healthcare, Inc.
2016-11-23	Z-0612-2017	Class II	ADVIA Centaur CA 19-9 Assay	Siemens Healthcare Diagnostics, Inc
2016-11-23	Z-0613-2017	Class II	ADVIA Centaur CA 19-9 Assay	Siemens Healthcare Diagnostics, Inc
2016-11-16	Z-0307-2017	Class I	Pipeline Embolization Device	Micro Therapeutics Inc, Dba Ev3 Neurovascular
2016-11-16	Z-0308-2017	Class I	Alligator Retrieval Device The device is intended for use in the…	Micro Therapeutics Inc, Dba Ev3 Neurovascular
2016-11-16	Z-0309-2017	Class I	Marathon Flow Directed Micro Catheter	Micro Therapeutics Inc, Dba Ev3 Neurovascular
2016-11-16	Z-0310-2017	Class I	X-Celerator Hydrophilic Exchange Guidewire Catalog No	Micro Therapeutics Inc, Dba Ev3 Neurovascular
2016-11-16	Z-0328-2017	Class I	FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is…	SentreHeart Inc
2016-11-16	Z-0361-2017	Class II	Symbiq One Channel Infuser	Hospira Inc.
2016-11-16	Z-0362-2017	Class II	Symbiq Two Channel Infuser	Hospira Inc.
2016-11-16	Z-0363-2017	Class II	X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation…	C.R. Bard, Inc.
2016-11-16	Z-0364-2017	Class II	Covidien Devon Light Glove packaged in sterile surgical kits…	Covidien LLC
2016-11-16	Z-0365-2017	Class II	Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers…	Covidien LLC
2016-11-16	Z-0366-2017	Class II	Professional Hospital Supply	Covidien LLC
2016-11-16	Z-0368-2017	Class II	Zimmer¿ Air Dermatome II Handpiece Loaner	Zimmer Surgical Inc
2016-11-16	Z-0369-2017	Class II	TBS iNsight Version v	Medimaps Group
2016-11-16	Z-0370-2017	Class II	GAMBRO Capillary Dialyzer	Baxter Healthcare Corp.
2016-11-16	Z-0371-2017	Class II	The surgical table is a stand alone unit	Schaerer Medical USA Inc
2016-11-16	Z-0372-2017	Class II	Replacement floor locking cylinders for the Schaerer model 7300…	Schaerer Medical USA Inc
2016-11-16	Z-0373-2017	Class II	SOMATOM Definition AS system	Siemens Medical Solutions USA, Inc
2016-11-16	Z-0374-2017	Class II	SOMATOM Definition Flash system	Siemens Medical Solutions USA, Inc
2016-11-16	Z-0377-2017	Class II	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip…	AtriCure, Inc.
2016-11-16	Z-0378-2017	Class II	LFIT Anatomic V40 Femoral Head	Stryker Howmedica Osteonics Corp.
2016-11-16	Z-0379-2017	Class II	ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used…	Abbott Laboratories
2016-11-16	Z-0380-2017	Class II	Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic…	Stryker Sustainability Solutions
2016-11-16	Z-0387-2017	Class II	Roche COBAS INTEGRA c111 Analyzer	Roche Diagnostics Operations, Inc.
2016-11-16	Z-0388-2017	Class II	SB Knife -Electrosurgical Knife	Akita Sumitomo Bakelite Co., Ltd.
2016-11-16	Z-0389-2017	Class II	SB	Akita Sumitomo Bakelite Co., Ltd.
2016-11-16	Z-0390-2017	Class II	Accessory Adapter Part number 600525A0 Product Usage: designed for…	Maquet Medical Systems USA
2016-11-16	Z-0391-2017	Class II	OR Table	Trumpf Medical Systems, Inc.
2016-11-16	Z-0392-2017	Class II	ReShape Integrated Dual Balloon System	Reshape Medical Inc
2016-11-16	Z-0393-2017	Class II	NRG Transseptal Needle and NRG RF Transseptal Kit	Baylis Medical Corp *
2016-11-16	Z-0394-2017	Class II	catalog # 405612 BD Spinal Anesthesia Tray 22G x 3	Becton Dickinson & Company
2016-11-09	Z-0086-2017	Class II	15 g R	Epimed International, Inc.
2016-11-09	Z-0321-2017	Class II	TD60 display Telemetry Transmitter	Mindray DS USA, Inc. dba Mindray North America
2016-11-09	Z-0322-2017	Class II	Visualase Visualization Stylets PN 020-2301	Medtronic Navigation, Inc.
2016-11-09	Z-0323-2017	Class II	Visualase Body Accessory Kit PN 020-3000	Medtronic Navigation, Inc.
2016-11-09	Z-0324-2017	Class II	Reprocessed Pressure Tourniquet Cuff	Stryker Sustainability Solutions
2016-11-09	Z-0325-2017	Class II	Empowr PS Knee System Box Cut Guide	Encore Medical, Lp
2016-11-09	Z-0326-2017	Class II	Product Number 3102071 Ceiling Bracket	Hill-Rom, Inc.
2016-11-09	Z-0327-2017	Class II	Affected Pain Control Tray Component	B. Braun Medical, Inc.
2016-11-09	Z-0329-2017	Class II	Glucose Tolerance Beverage- Orange 50 gram Concentration	Azer Scientific, Inc.
2016-11-09	Z-0330-2017	Class II	Fruit Punch Glucose	Azer Scientific, Inc.
2016-11-09	Z-0331-2017	Class II	HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow…	Arrow International Inc
2016-11-09	Z-0332-2017	Class II	Xhibit Central Station	Spacelabs Healthcare Inc
2016-11-09	Z-0333-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0334-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0335-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0336-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0337-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0338-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0339-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0340-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0341-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0342-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0343-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0344-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0345-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0346-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0347-2017	Class II	Guider Softip XF	Stryker Neurovascular
2016-11-09	Z-0348-2017	Class II	Heater Cooler Unit Usage: The Heater-Cooler Unit	Maquet Cardiovascular Us Sales, Llc
2016-11-09	Z-0349-2017	Class II	Model 055: Thermophore Classic	Battle Creek Equipment Co.
2016-11-09	Z-0350-2017	Class II	TANDEM	Smith & Nephew, Inc.
2016-11-09	Z-0351-2017	Class II	TANDEM	Smith & Nephew, Inc.
2016-11-09	Z-0352-2017	Class II	Rigid Suction Canister 3000 CC and 2000 CC	Medline Industries Inc
2016-11-09	Z-0353-2017	Class II	Symbiq One Channel Infuser	Hospira Inc.
2016-11-09	Z-0354-2017	Class II	Symbiq Two Channel Infuser	Hospira Inc.
2016-11-09	Z-0355-2017	Class II	Infusion Set	Unomedical As
2016-11-09	Z-0356-2017	Class II	Contact Detach	Unomedical As
2016-11-09	Z-0357-2017	Class II	AC TenderLink 13/30 10 pcs	Unomedical As
2016-11-09	Z-0358-2017	Class II	Comfort 5+5 Pack w/110cm Tube & 17mm Cann	Unomedical As
2016-11-09	Z-0359-2017	Class II	Silhouette Paradigm 13mm	Unomedical As
2016-11-09	Z-0360-2017	Class II	SureT G29 6mm	Unomedical As
2016-11-02	Z-0094-2017	Class II	Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P:…	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0095-2017	Class II	cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product…	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0096-2017	Class II	cobas 6000 Series system c6000	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0097-2017	Class II	cobas 8000 Modular Analyzer Series c8000	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0098-2017	Class II	Modular Pre Analytics	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0099-2017	Class II	URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage:…	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0100-2017	Class II	Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0101-2017	Class II	cobas p 701 Post-Analytical Unit calculator/data processing module	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0102-2017	Class II	cobas p 501 Post-Analytical Unit calculator/data processing module	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0103-2017	Class II	VS II Aliquoter System calculator/data processing module	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0104-2017	Class II	RSD 800A Aliquoting System calculator/data processing module	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0105-2017	Class II	RSD 800 Sorting System calculator/data processing module	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0106-2017	Class II	cobas p 612 Pre-Analytical Instrument calculator/data processing…	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0107-2017	Class II	cobas p 512 Pre-Analytical Instrument calculator/data processing…	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0108-2017	Class II	cobas p 471 centrifuge unit calculator/data processing module	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0109-2017	Class II	cobas p 312 Pre-Analytical System calculator/data processing module	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0110-2017	Class II	cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage:…	Roche Diagnostics Operations, Inc.
2016-11-02	Z-0114-2017	Class II	VIA 27 Microcatheter	Sequent Medical Inc
2016-11-02	Z-0115-2017	Class I	Fortify VR	St Jude Medical Inc.
2016-11-02	Z-0116-2017	Class I	Unify	St Jude Medical Inc.
2016-11-02	Z-0117-2017	Class I	Quadra Assura	St Jude Medical Inc.
2016-11-02	Z-0297-2017	Class II	The PAXWIRE Occlusion Balloon System consists of an occlusion catheter	AccessClosure, Inc., A Cardinal Health Company
2016-11-02	Z-0298-2017	Class II	Neptune Plus	TZ Medical, Inc.
2016-11-02	Z-0299-2017	Class II	Keystone Dental PrimaConnex¿ Straight Implant TC	Keystone Dental Inc
2016-11-02	Z-0300-2017	Class II	enGen Laboratory Automation System	Ortho-Clinical Diagnostics
2016-11-02	Z-0301-2017	Class II	FemTouch delivery system includes the FemTouch Kit	Lumenis Limited

← Newer · Older →