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

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WILDCAT 7F GUIDEWIRE SUPPORT CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Zavation

FDA UDI
Zavation LLC·00842166177338·Z-Link Lumbar Sizer 8 deg, 33mm x 13

Zavation

FDA UDI
Zavation LLC·00842166112315·Z-Link Lumbar Spacer 8deg 33mmx13

INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·August 6, 2024

QUATRO M FEMORAL COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

FILAC FAS TEMP ELECTRONIC THERMOMETER

FDA 510(k)
FDA Class 2 ·General Hospital

PLATE, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HRS·November 16, 2015

4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·December 9, 2015

M2A-MAGNUM 42-50MM TPR INSRT-3

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·April 29, 2013

GUIDEWIRE

FDA Adverse Event
Malfunction ·GALT MEDICAL CORP.·Product code DQX·April 13, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 25, 2008

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·September 1, 2016

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·December 4, 2015

4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM

FDA Adverse Event
Injury ·SYNTHES GRENCHEN·Product code HWC·December 18, 2015

BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018