19 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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