15 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.

APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0

FDA 510(k)
FDA Class 2 ·Radiology

K2M General Instruments

FDA UDI
VB Spine LLC·10888857581548·Split Tube Retractor Ø26x110 mm

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973578·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973837·

OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770

FDA 510(k)
FDA Class 2 ·Orthopedic

LIFEPAK 12 DEFIBRILLATOR/MONITOR

FDA 510(k)
FDA Class 3 ·Cardiovascular

MUSTANG?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 24, 2025

MEDTRONIC MINIMED 670G

FDA Adverse Event
Injury ·MEDTRONIC·Product code CGA·December 6, 2016

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·June 3, 2013

TOTAL ASR ACET IMP SIZE 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011

MUSTANG

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 2, 2025

cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

PKG, 3MM X 29CM INSERT, DISSECTING FORCEPS, P/N 0250282110 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026