13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GREINER VACUETTE QUICKSHIELD COMPLETE
FDA 510(k)
FDA Class 2
·General Hospital
PMMA disc
FDA UDI
Dentsply International Inc.·D00180723200·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0123200·Inserter, Tulips and Connectors
POWERPRO BATTERY SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACCOLADE C FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
OSTAPEK VBR CAGE
FDA Adverse Event
Injury
·COLIGNE AG·Product code MQP·September 19, 2019
UROLUME ENDOPROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MER·April 17, 2013
ANTHEM RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·September 9, 2014
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DXY·July 10, 2008
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
FDA Enforcement
Class II
·Ongoing·Lacrimedics Inc·March 9, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025