410 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
FDA 510(k)
FDA Class 2
·Neurology
PMMA disc
FDA UDI
Dentsply International Inc.·D00180820120·
Non-Locking Screw, 2.4mm x 12mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665026122·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694038843·2.0mm x 12mm Midface Screw
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193101996·EVOS Rotate HA PEEK 12mm x 9mm x 26mm Flat, 8°
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ECG HOME
FDA 510(k)
FDA Class 2
·Cardiovascular
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·November 26, 2019
SELENIA MAMMOGRAPHY SYSTEM
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code GEI·March 7, 2012
MEDI-LAB PERFORMANCE HCG URINE TEST-CASSETTE
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·November 11, 2011
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·November 29, 2012
ARTHREX
FDA Adverse Event
ARTHREX·Product code MAI·September 19, 2012
AMS 800 URINARY CONTROL SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZY·December 1, 2018
OT PING METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
LINOX SD 75/18
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·April 25, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·July 22, 2008
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Injury
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 12, 2010
11 CM ANGLE ATTACHMENT QD11
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 13, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Injury
·ZOLL MANUFACTURING CORPORATION·Product code MVK·March 17, 2015
ARTEFILL
FDA Adverse Event
Injury
·SUNEVA·Product code LMH·November 13, 2011