19 results · 21ms · Sources: EU EUDAMED, US FDA

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HAPTITE COATING IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

CoRoent

FDA UDI
Nuvasive, Inc.·00887517574053·CoRoent Ant TLIF Ti, 11x11x36mm 4°

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089430932·

Summa Orthopaedics System Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089466290·

SCREW,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HWC·June 9, 2017

LANX FACET SCREW SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

VALUTRUS LC HANDLE

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code ODC·October 14, 2015

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·May 9, 2013

PROFEMUR(R) MODULAR FEMORAL NECK

FDA Adverse Event
Injury ·MICROPORT ORTHOPEDICS INC.·Product code LWJ·September 23, 2014

XPRT SLEEP SURFACE

FDA Adverse Event
Malfunction ·STRYKER CORP DBA GAYMAR·Product code FNM·May 18, 2011

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 8, 2018

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code HWC·June 2, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code HWC·June 3, 2015

OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018