12 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Integra® Miltex®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780362104·Integra® Miltex® Westcott Tenotomy Scissors, 5-...

POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE

FDA 510(k)
FDA Class 1 ·General Hospital

MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003

FDA 510(k)
FDA Class 2 ·Cardiovascular

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

PROTECTA XT CRT-D

FDA Adverse Event
Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 21, 2013

ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 44

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·March 9, 2021

ANATOMICAL SHOULDER SYSTEM HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·November 8, 2022

EPIQ 7C ULTRASOUND CHINA LOCAL

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND (SHANGHAI) CO., LTD·Product code IYN·June 2, 2023

DEKA MOTUS AY

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 18, 2019

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012