32 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493929641·AVANOS* Universal Block Trays
Halyard
FDA UDI
Avanos Medical, Inc.·10680651929645·HYH,UBLOCK,UBT,-,-,10
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515025172·Koerte Ret, 8 prong, sharp, 9 1/2"
Free-Lock®
FDA UDI
Zimmer, Inc.·00889024035447·
Free-Lock®
FDA UDI
Zimmer, Inc.·00889024035430·
BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·April 11, 2019
AIR OPTIX AQUA
FDA Adverse Event
Injury
·CIBA VISION JOHORE SDN, BHD·Product code LPM·July 22, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 21, 2013
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·September 30, 2008
VANGUARD PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·June 11, 2024
UNKNOWN VANGUARD FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 11, 2024
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·April 15, 2019
OT VITA ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 14, 2012
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant.
FDA Recall
Terminated
·Zimmer, Inc.·Product code KTT·June 19, 2013
Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·September 19, 2018
BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·December 12, 2018
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 4, 2013