37 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
FDA 510(k)
FDA Class 2
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00842528102107·4.7 mm Cannulated Over Drill, Standard AO Quick...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694042987·1.6mm x 6mm Screw
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321616060·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311616060·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528108246·4.7 mm Cannulated Over Drill, Standard AO Quick...
VACUTRON
FDA UDI
Allied Medical, LLC·00026072009369·INTERMITTENT SUCTION REGULATORS
DEFIBRILLATOR CABLE TESTER, MODEL DT2200
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROMED PD-8K INSULATION DEFECT DETECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·February 13, 2019
LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·May 1, 2017
LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·May 30, 2017
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 8, 2024
1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·February 13, 2019
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
VICRYL SUTURE
FDA Adverse Event
Injury
·ETHICON INC, SUBSIDARY OF JOHNSON AND JOHNSON·Product code GAM·June 7, 2013
OLYMPUS ELECTROSURGICAL UNIT
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KNS·July 23, 2014
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·February 28, 2018
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·February 26, 2020
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·February 26, 2020