23 results · 22ms · Sources: EU EUDAMED, 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