19 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Sutter CURIS RF Generator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
M.U.S.T. MINI POLYAXIAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·August 27, 2025
MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·April 6, 2018
MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·March 8, 2022
TENS/IF 14
FDA 510(k)
FDA Class 2
·Neurology
PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)
FDA 510(k)
FDA Class 2
·Dental
MUST MINI ROD TI 3.5 X 80MM (STERILE)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·July 13, 2021
ORS-100 FLUID WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·April 4, 2018
MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·July 14, 2020
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
ALTRX NEUT 36IDX52OD
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code LPH·June 17, 2013
FOGARTY ARTERIAL EMBOLECTOMY CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DXE·July 22, 2011
MUST MINI POLYAXIAL SCREW 3.5 X 18 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·October 27, 2022
MUST MINI ROD REDUCTION DEVICE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·September 27, 2019
M.U.S.T. MINI POLYAXIAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·August 11, 2025
MUST MINI POLYAXIAL SCREW 3.5 X 20 FULL THREAD + NUT
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·February 2, 2018
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021