21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
FDA 510(k)
FDA Class 2
·Hematology
Diamond D
FDA UDI
Keystone Industries·H66810130781·Denture Acrylic SC Light 5 lb P&L
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458082·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458075·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458068·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458099·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01307N0·Cervical Rasp, 14 x 11, 7mm, 0 Degree, No Taper
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458112·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458044·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458051·
SYNCHRON VANCOMYCIN REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011
MERIT DRAINAGE DEPOT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
FDA 510(k)
FDA Class 1
·General Hospital
POSSIS SUTURELESS MYOCARDIAL LEAD
FDA Adverse Event
Injury
·POSSIS MEDICAL, INC.·Product code LWS·October 9, 1995
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 25, 2020
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 19, 2019
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 20, 2013
PFC SIGMARP CV TB/IN S4 12.5
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code NJL·August 15, 2014
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
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