14 results · 26ms · Sources: EU EUDAMED, US FDA

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Digital Thermometer

FDA 510(k)
FDA Class 2 ·General Hospital

sentida 1

FDA UDI
WISSNER-BOSSERHOFF GmbH·04050621100401·Basic electric home bed

GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL

FDA 510(k)
FDA Class 2 ·Orthopedic

EPOLY 32MM RLC LNR MROM SZ23

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 7, 2018

CER BIOLOXD OPTION HD 32MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 7, 2018

TPRLC 133 MP TYPE1 PPS HO 10.0

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 7, 2018

M/H SLD/APX HLE RNGLC SHL 50MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 7, 2018

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·July 29, 2011

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013

INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 14, 2019

INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 19, 2019

SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198

FDA Enforcement
Class II ·Ongoing·WISSNER-BOSSERHOFF GMBH·November 20, 2024