18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LongBow Ti
FDA 510(k)
FDA Class 2
·Orthopedic
LOCKING BONE SCREW MODEL HCQ04, HCZ04
FDA 510(k)
FDA Class 2
·Orthopedic
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FOX PLUS PTA CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR SWITZERLAND·Product code LIT·October 6, 2008
PINN SECTOR W/GRIPTION 58MM
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code LPH·June 26, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·July 26, 2011
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code JJE·October 10, 2019
AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 5, 2026
MICRUSFRAME10 6MM X 11.9CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022
GALAXY G3 XSFT 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022
GALAXY G3 XSFT 2.5MM X 3.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022
GALAXY G3 XSFT 4MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020