11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARCTEC SEMIRIGID PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821051044·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
EXPLANT™
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311657·
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
FDA 510(k)
FDA Class 1
·General Hospital
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·April 10, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·May 22, 2008
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·November 24, 2025
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018
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