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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PERIFIX CATHETER CONNECTOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033952·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...
Masterline
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746164606·INSTRUMENT MASTERLINE SHEAR AND HOLD DISTAL END...
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INDIGO LASEROPTIC TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITEK® 2 AST-YS08 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code NGZ·January 11, 2018
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·April 3, 2013
ADJ PIN COLLET 2.0-3.2MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·March 23, 2011
CORAIL2 LAT COXA VARA SIZE 11
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code KWA·April 24, 2008
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024