20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code JDS·February 13, 2017
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
FDA 510(k)
FDA Class 2
·Orthopedic
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 5, 2016
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856084513·POLYAXIAL SCREW, 7.2mm X 95mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00190376078007·Polyaxial Reduction Screw, 7.2 mm x 95 mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00190376074207·Polyaxial Screw, 7.2 mm x 95 mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856085664·SACRAL POLYAXIAL SCREW, 7.2mm X 95mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856086845·POLYAXIAL REDUCTION SCREW, 7.2mm X 95mm
Optimus Drill Q – 4.0mm 40mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215109356·
SNAP MODEL 6
FDA 510(k)
FDA Class 2
·Anesthesiology
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX)
FDA 510(k)
FDA Class 2
·Orthopedic
LINEAR? 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 9, 2026
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 28, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 13, 2022
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR W/ INTEGRATED RESERVOIR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·November 15, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017