16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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