47 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);
FDA 510(k)
FDA Class 2
·Radiology
Bradshaw Medical Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019930881·BIT, HEX MALE 7/64 1/4 SQ
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111580·Modular Stem 11mm x 100mm
Kleiner KG2 system
FDA UDI
Baat Medical Products B.V.·08720246782776·Trial
Preference
FDA UDI
CTL Medical Corporation·00841732152786·7.2mm Polyaxial Triple-lead screw 110mm Green
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555287250110·ø7.2 Triple Lead Screw Assembly, 110mm
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
FDA 510(k)
FDA Class 1
·General Hospital
SYNTHES (USA) LCP MODULAR FOOT PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·August 1, 2002
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·August 5, 2002
CAGORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Death
·W.L. GORE & ASSOCIATES·Product code MIH·February 12, 2010
PFC*SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code JWH·September 15, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 22, 2013
QUATTRODE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·July 23, 2013
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Recall
Open, Classified
·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025
ORTHOPEDIC SALVAGE SYSTEM 22MM TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·August 20, 2018
BIOMET SUTURE BUTTON SINGLE ¼ INCH PEG WITH WIRE 37MM X 10MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·August 20, 2018
ORTHOPEDIC SALVAGE SYSTEM YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·August 20, 2018
ORTHOPEDIC SALVAGE SYSTEM POROUS COATED IM STEM WITH SCREW 14.5MM X 90MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 10, 2018