19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271470·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304466081·
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071150846·18F x 3.5cm MiniSPC Low Profile Suprapubic Cath...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071148225·18F x 3.5cm MiniSPC Low Profile Suprapubic Cath...
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
FDA 510(k)
FDA Class 2
·General Hospital
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
FDA 510(k)
FDA Class 2
·Radiology
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·January 27, 2017
M2A MAGNUM TAPER ADAPTOR
FDA Adverse Event
Injury
·BIOMET INC.·Product code KWA·October 3, 2008
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 29, 2011
UNKNOWN BIOMET ARCOM 3 PEG PATELLA 31MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 6, 2018
VANGUARD CRUCIATE RETAINING INTERLOK FEMORAL COMPONENT RIGHT 62.5MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 6, 2018
BIOMET CC I-BEAM TIBIAL TRAY 67MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 6, 2018
VANGUARD UNKNOWN KNEE PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
VANGUARD CR FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
BIOMET CC I-BEAM TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025