9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033656·Baltic Denture System BDLoad BDLoad Lw6 PLSEbi...
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
FDA 510(k)
FDA Class 2
·Radiology
X-POSURE SYSTEM VERSION 2 MAMMO
FDA 510(k)
FDA Class 2
·Radiology
MIC G-18 INTRODUCER KIT
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK HEALTH CARE·Product code KNT·April 3, 2013
UNKNOWN DEPUY ASR 54 CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 17, 2011
PINN MAR NEUT 32IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·August 25, 2014
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