46 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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