17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
Asnis
FDA UDI
Stryker GmbH·07613154578054·CANNULATED SCREW
Ormco
FDA UDI
ORMCO CORPORATION·00889989075809·HOLLOW CHOP CONTOURING PLIERS
SCFE Screw
FDA UDI
ORTHOPEDIATRICS CORP.·00841132114339·4.0mm X 22mm FULL THREAD CANNULATED SCREW
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)
FDA 510(k)
FDA Class 2
·Orthopedic
SMARTFLOW, MODEL SFIP 2000
FDA 510(k)
FDA Class 2
·Cardiovascular
Widex
FDA UDI
Widex A/S·05706069684452·COMPASS GPS V2.5 package (Spanish)
Widex
FDA UDI
Widex A/S·05706069684438·COMPASS GPS V2.5 package (German)
Widex
FDA UDI
Widex A/S·05706069684445·COMPASS GPS V2.5 package (French)
Widex
FDA UDI
Widex A/S·05706069684421·COMPASS GPS V2.5 package (English)
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 2, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 26, 2011
C-PORT XCHANGE DISTAL ANASTOMOSIS SYSTEM
FDA Adverse Event
Injury
·CARDICA, INC.·Product code FZP·April 15, 2008
RSP SHOULDER
FDA Adverse Event
Injury
·ENCORE MEDICAL L.P.·Product code KWS·July 7, 2017
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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016