10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Exactech® Alteon® HA Femoral Stem
FDA 510(k)
FDA Class 2
·Orthopedic
VASOGRAD DVT COMPRESSION GARMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
TOMAS PIN 6 MM
FDA 510(k)
FDA Class 2
·Dental
MPACT ACETABULAR SHELL 56 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 20, 2020
PURITAN BENNETT 980 SERIES VENTILATOR
FDA Adverse Event
Malfunction
·MEDTRONIC/COVIDIEN·Product code CBK·September 17, 2025
CONCERTO CRT-D DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·July 14, 2011
PAINSMART
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 13, 2013
5.0MM DIA TPRD HD PER SCRW 45
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JDL·September 15, 2008
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
FDA Enforcement
Class II
·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·September 5, 2012
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015