23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Multi-LinkTM X2 ECG Adapter and Leadwires
FDA 510(k)
FDA Class 2
·Cardiovascular
ReLine
FDA UDI
Nuvasive, Inc.·00195377047496·RELINE-O Trial, 6mm H Offset Right L-pop
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055193·METZENBAUM SCISSORS CURVED TUNGSTEN CARBIDE SER...
Screwdriver
FDA UDI
Treace Medical Concepts, Inc.·00810111226622·5.0mm VPCS ZSJ SCREWDRIVER, CANNULATED
Zavation
FDA UDI
Zavation LLC·00842166131668·Ti3Z CIF 12mmx14mmx10mm -5 deg
OsteoMed
FDA UDI
OSTEOMED LLC·00845694006712·Bending Iron, Recon Plates
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869692748·MOSS VRS Approximator HP
ART-M1, MODEL M1-1-ART-A1
FDA 510(k)
FDA Class 2
·Dental
SMOKE EVACUATION HOSES/TUBING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code IOR·July 1, 2013
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code HSD·December 2, 2025
ENDOSKELETON¿ TAS INTERBODY SYSTEM
FDA Adverse Event
Malfunction
·TITAN SPINE, A DIVISION OF MEDTRONIC·Product code OVD·July 9, 2025
BD¿ FEMALE LUER LOCK ADAPTER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·April 14, 2023
BD¿ FEMALE LUER LOCK ADAPTER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·April 14, 2023
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·October 20, 2021
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·August 3, 2018
SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.
FDA Enforcement
Class II
·Terminated·Ormco/Sybronendo·June 26, 2013
SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.
FDA Recall
Terminated
·Ormco/Sybronendo·Product code EKR·January 17, 2013