46 results · 23ms · 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.

CARDIO MED MODEL A102, H104, O101, P103, AND Z100

FDA 510(k)
FDA Class 2 ·Cardiovascular

Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

FDA Enforcement
Class II ·Terminated·Cardio Medical Products·July 17, 2013

PMT CORPORATION - STEREOTACTIC

FDA UDI
PMT CORPORATION·00650551141389·HOLE PUNCH

ANTI BUCKLE WIRE TWISTER

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051867·ANTI BUCKLE WIRE TWISTER WITH GUARD TUNGSTEN CA...

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172971185·

CORDIS SLALOM PTA BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

HRH-63-8 HEAD ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

AMISTEM H, HA COATED STEM SIZE 3 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2016

BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·November 16, 2023

AMISTEM C FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 27, 2026

AMISTEM C FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 26, 2026

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 9, 2013

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·September 19, 2014

ULTRASOFT LANCING DEVICE

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·May 25, 2011

LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø40/G

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·April 14, 2022

AMISTEM C FEMORAL STEMS

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JDI·July 17, 2025

LINER: MPACT FLAT PE HC LINER Ø36/E

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 21, 2018

NC TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 24, 2019

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 56

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 17, 2020