18 results · 28ms · Sources: EU EUDAMED, US FDA

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ZIMMER UNICOMPARTMENTAL KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code HSX·February 3, 2017

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033363·Baltic Denture System BDLoad BDLoad ↓ Mm7 PLSEu...

CROSSPOINT TRANSACCESS CATHETER

FDA 510(k)
FDA Class 2 ·Radiology

M2A 32MM TAPER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014

PROSTHESIS, HIP

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021

D903 DIDECO AVANT 2 VAVD PHISIO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·February 19, 2014

IT PADOVA

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·August 8, 2013

D903 DIDECO AVANT VAVD PHISIO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·August 16, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 3, 2013

DYNAMIC COMPRESSION SMA STAPLE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·March 30, 2011

ACRYSOF TORIC

FDA Adverse Event
Injury ·ALCON RESEARCH LTD / HUNTINGTON·Product code HQL·April 24, 2008

C20441 IL HAIFA

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DWF·March 28, 2012

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013