17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Humelock Reversed Shoulder
FDA UDI
FX SOLUTIONS·03701037306208·HUMELOCK REVERSED REAMER Ø9mm
Asnis
FDA UDI
Stryker GmbH·07613154632619·CANNULATED SCREW
Discectomy Set
FDA UDI
SPINEOLOGY INC.·M7403030109·15mm Shaver
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101090·Distractor, Smooth Paddle, Lordotic, 9mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101090·Distractor, Smooth Paddle, 9mm
FLUOROPERM 151-OK, PARAGON HDS 100-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
FDA 510(k)
FDA Class 2
·Ophthalmic
MOBILE INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·November 25, 2010
MOBILE INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·November 28, 2010
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·April 2, 2013
COULTER LH 750 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LOQ·March 26, 2011
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·April 14, 2008
BABY CONTROL MOBILE INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·September 20, 2012
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