9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
FDA 510(k)
FDA Class 1
·Microbiology
NA
FDA UDI
Stryker GmbH·00886385005720·Lag Screw, Non-Locking, Self-tap., T6 Drive
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
FDA 510(k)
FDA Class 1
·Ophthalmic
MAINSTREAM WATER PURIFICATION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 11, 2013
COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code FMT·May 23, 2008
SIG MOD TIB TRAY CEM COCR 2.5
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code JWH·April 7, 2011
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
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