11 results · 22ms · 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.

KUMAR T-ANCHORS HERNIA SET

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Speedlock

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657064606·Biopsy Spoon, 5mm, Double Action Handle: 1366 ...

Speedlock

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657062244·Needle Holder, Pointed, 5mm, 10mm Jaw Length H...

PROSTEC 125I BRANCHYTHERAPY SNAPSEED

FDA 510(k)
FDA Class 2 ·Radiology

CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ENERGEN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 26, 2013

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 22, 2011

PULSE GEN MODEL 101

FDA Adverse Event
Death ·CYBERONICS, INC.·Product code LYJ·July 24, 2008

BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

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

Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

FDA Enforcement
Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015