29 results · 28ms · 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.

TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

Safco DENTA-SAFE NON-LATEX DENTAL DAM

FDA UDI
SAFCO DENTAL SUPPLY CO.·20810063750163·Heavy (0.23mm-0.28mm thickness) 6" x 6", green,...

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496020783·RELAX UNISEX 70, SIZE L, BORDEAUX, GRADUATED CO...

iDock51 Audio/Video Extend Module

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904095547·

iDock51 Audio/Video Extend Module

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904048970·

DIRECT TIBC CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FIXION INTERLOCKING NAIL (FIXION IL NAIL)

FDA 510(k)
FDA Class 2 ·Orthopedic

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·December 17, 2018

ZILVER BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·March 5, 2020

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·September 26, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

EMAX 2 PLUS MOTOR

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 18, 2013

RENEGADE HI-FLO MICROCATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRA·March 16, 2011

*

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·March 17, 2008

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017