13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Waterlase Laser Tips
FDA UDI
Biolase, Inc.·00647529000533·A tip kit containing 20 single-use MZ5 Zip tip...
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003722·Diagnostic EP Catheter, Damato curve, 4 electro...
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964095351·Endo Carry-On Procedure Kit
UROSTATION 3D PROSTATE SUITE
FDA 510(k)
FDA Class 2
·Radiology
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNK
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code GZB·December 17, 2007
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 29, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·January 2, 2019
GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, -4MM
FDA Adverse Event
Injury
·ENCORE MEDICAL L.P·Product code PHX·June 13, 2023