23 results · 23ms · Sources: EU EUDAMED, US FDA

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SpeediCath Soft

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777594·LUMBAMED BASIC DORSAL STAY WM SILVER II

GERALD TISSUE FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060197·GERALD TISSUE FORCEPS TUNGSTEN CARBIDE PLATFORM...

Cut Guide

FDA UDI
Treace Medical Concepts, Inc.·00810111222808·STEPPED INLINE CUT GUIDE, MEDIUM

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113943·B-H IRRIGATING CAN 19GA FLAT ANGLED 8MM

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780182146·Integra® Jarit® Sauerbruch Retractor, 9", 7/8" ...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306805011·Cerkes Medial Oblique Osteotome, 4mm

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319705926·Noyes Alligator Forceps 6-1/2" (16.5cm) shaft, ...

Initia Total Hip System

FDA UDI
KYOCERA CORPORATION·04547898306761·MX LINER 32-48

MICROSCAN SYNERGIES PLUS

FDA 510(k)
FDA Class 2 ·Microbiology

MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE

FDA 510(k)
FDA Class 1 ·General Hospital

SMR SYSTEM

FDA Adverse Event
Malfunction ·LIMACORPORATE S.P.A.·Product code KWT·February 13, 2025

EQUINOXE REVERSE 42MM HUMERAL LINER +2.5

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·August 7, 2023

TRUERESULT

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 21, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011

ENDURANT II

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·July 1, 2013

SMR REVER. LINER RETENTIVE STD

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code PHX·September 10, 2024

H-MAX S STANDARD FEM. STEM #13

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code MEH·December 18, 2018

ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

FDA Enforcement
Class II ·Terminated·SynCardia Systems Inc.·January 9, 2013