16 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.

VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C

FDA 510(k)
FDA Class 2 ·Cardiovascular

Malecot

FDA UDI
COOK INCORPORATED·00827002169258·Silicone Malecot Catheter

DISPOSABLE CB-PE MICROKERATOME BLADES

FDA 510(k)
FDA Class 1 ·Ophthalmic

FINN CHAMBER (R)

FDA 510(k)
FDA Class 1 ·General Hospital

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 25, 2022

ARTICULEZE M HEAD 36MM +5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·August 21, 2013

OT VERIO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 10, 2011

MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code LXH·July 25, 2008

AML 15.0 MMA 6.3 5/8 STD 12/14

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 18, 2013

PINNACLE MTL INS NEUT36IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·June 29, 2012

ARTICULEZE M HEAD 36MM +5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 20, 2012

PINNACLE MTL INS NEUT36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 20, 2012

CANNULA & CATHETER

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012