19 results · 22ms · Sources: EU EUDAMED, US FDA

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TECHFIT DISRP® System

FDA 510(k)
FDA Class 2 ·Dental

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776371739·Sauerbruch Rib Rongeur, square bite, double action

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780382805·Integra® Jarit® Sauerbruch Rib Rongeur, 11-3/4"...

Oticon

FDA UDI
Sbo Hearing A/S·05714464029686·OTICON MORE 2 MINIRITE T C092

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114278·CHAMBER MAINTAINER 20GA (PK/10)

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540347794·BIPOLAR FORCEPS

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776092962·Sauerbruch Stille Rong,

devemed

FDA UDI
devemed GmbH·04061644030903·Anatomical tweezers, micro diamond coated | 0.6...

FLAT PANEL DISPLAYS, CDL SERIES

FDA 510(k)
FDA Class 2 ·Radiology

DIMENSION EXL WITH LM SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIMENSION EXL 200

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·June 3, 2016

3DKNEE

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code HSH·November 7, 2008

COULTER® LH 500 INSTRUMENT

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 1, 2011

ECHELON 60 ENDOPATH

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 16, 2013

DIMENSION EXL WITH LM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013

Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1

FDA Enforcement
Class II ·Ongoing·Busse Hospital Disposables, Inc.·December 7, 2022

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

UNKNOWN KNEE COMPONENT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·January 7, 2025