12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BACKPACK MEDICAL OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Brasseler
FDA UDI
Provision·B504OMKM715810·
NA
FDA UDI
STERILMED, INC.·10888551007689·SAW BLADE OSCILLATING LARGE BONE
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 20, 2020
PF4 IGG
FDA Adverse Event
Malfunction
·IMMUCOR GTI DIAGNOSTICS·Product code GWG·January 16, 2015
AMERITEK BRACHYTHERAPY TEMPLATE
FDA 510(k)
FDA Class 2
·Radiology
LACTOSORB 5.0 MM WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·April 22, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011
AVIATOR PLUS PTA DILATATION CATHETER
FDA Adverse Event
Injury
·CORDIS EUROPA, N.V.·Product code LIT·July 7, 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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018