21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304003903·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528114339·1.6MM DRIVER STEM W/POST, AO SHNK, LONG
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929038918·Corpectomy, 14Dx16Wx52H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065327·Corpectomy, 14Dx16Wx52H 0°
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2026
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIM·June 27, 2011
BIOMET TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 2, 2018
VANGAURD SSK INTERLOCKING FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
VANGUARD FEMORAL POSTERIOR AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2018
VANGUARD FEMORAL POSTERIOR AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2018
VANGUARD FEMORAL DISTAL AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2018
VANGUARD SSK INTERLOK FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017
VANGUARD POSTERIOR STABILIZED TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017