67 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code PNJ·August 6, 2019
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code PNJ·August 6, 2019
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 14, 2017
Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 14, 2017
Bedside PICC CDS Convenience Kit
FDA Recall
Terminated
·Medline Industries Inc·Product code OEZ·October 27, 2021
Neuro Convenience Kit
FDA Recall
Terminated
·Medline Industries Inc·Product code OJG·October 27, 2021
Major Vascular CDS Convenience Kit
FDA Recall
Terminated
·Medline Industries Inc·Product code LRO·October 27, 2021
Venous Access Pack-LF Convenience Kit
FDA Recall
Terminated
·Medline Industries Inc·Product code OFF·October 27, 2021
EVLP Convenience Pack/Kit
FDA Recall
Terminated
·Medline Industries Inc·Product code LRO·October 27, 2021
Outlook Pump Set w/150 ml Burette w/15um Filter & Inj Site, Check Valve, 2 Inj Sites, 120 in V7421M
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 24, 2009
Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeline Inj Sites, 120 in NF3115M
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 24, 2009
Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 24, 2009
Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 24, 2009
Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Safesite Inj Sites, Check Valve 120 in SS3115M
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 24, 2009
Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, B/C Valve, 2 Ultrasite Inj Sites, 120 in US3121M
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·November 24, 2009
Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk)
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·June 30, 2008
Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff 87 in. Item/Catalog number 375113. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk)
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FPA·June 30, 2008
Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FRN·June 30, 2008
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·July 16, 2014
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 3, 2014