16 results · 21ms · Sources: EU EUDAMED, US FDA

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DOSEVIEW 3D

FDA 510(k)
FDA Class 2 ·Radiology

SONTEC HYBRID I.M. PIN CHUCK

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896052116·SONTEC HYBRID I.M. PIN CHUCK UNIVERSAL WITH OR ...

PMT CORPORATION - STEREOTACTIC

FDA UDI
PMT CORPORATION·00650551147060·SPLIT BUSHING FOR ROSA SEEG DEPTH PLACEMENT

SONTEC HYBRID I.M. PIN CHUCK SET

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896090910·SONTEC HYBRID I.M. PIN CHUCK SET 3/8 INCH WITH ...

3.0 ML RESERVOIR, MODEL 103/193

FDA 510(k)
FDA Class 2 ·General Hospital

DUPLOGRIP

FDA 510(k)
FDA Class 2 ·General Hospital

MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE

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

BLAKE DRAIN

FDA Adverse Event
Injury ·ETHICON, INC.·Product code KOG·February 10, 2012

NC TREK CORONARY DILATATION CATHETER

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

I-STAT TROPONIN (CTNI) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 8, 2023

ACCU-CHEK ® ACTIVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 9, 2013

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
KENSTONE METAL·Product code ITJ·September 19, 2014

ADAPTA DR

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code NVZ·May 25, 2011

Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

FDA Enforcement
Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

FDA Enforcement
Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024