18 results · 31ms · Sources: EU EUDAMED, 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