13 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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NAVIPRO KNEE SOFTWARE MODULE
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033668·Baltic Denture System BDLoad BDLoad Sm7 PLSEbm...
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BERCHTOLD ELEKTROTOM 106 HITT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 16, 2006
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·November 20, 2013
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·April 3, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 25, 2014
EON IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 11, 2011
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HSB·January 22, 2017
UNKNOWN PFM-R DISTAL STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
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