28 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OnGuard2 Chemfort Closed Administration (CADM)
FDA 510(k)
FDA Class 2
·General Hospital
TWINFIX
FDA UDI
Smith & Nephew, Inc.·03596010532190·TWINFIX 3.5 MM TITANIUM SUTURE
...
LUPINE PANACRYL
FDA UDI
DEPUY MITEK, LLC·10886705001057·LUPINE LOOP PLUS ANCHOR w/PANACRYL PLA Absorbab...
Zavation
FDA UDI
Zavation LLC·00842166132351·Ti3Z CIF 13mmx15mmx7mm -7 deg
ZAVATION
FDA UDI
Zavation LLC·00842166104440·CIF 13x15, 7 deg, -07
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319707401·Freeman Rake Retractor 2" (5cm), 4 sharp prongs...
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522107070·
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
FDA 510(k)
FDA Class 2
·Cardiovascular
CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 23, 2012
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 23, 2012
PINNACLE 100 ACET CUP 54MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·December 6, 2012
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·October 23, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 12, 2011
UNIFY ASSURA CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013
TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·August 7, 2020
TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·August 20, 2020
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 27, 2024
Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·January 27, 2012
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·September 28, 2022