16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Sklar®
FDA UDI
SKLAR CORPORATION·10649111147517·COLLINS TONGUE SEIZ FCP 6 1/2"
HALL
FDA UDI
Conmed Corporation·10845854000137·LARGE BONE, HALL BLADE, OSCILLATING, ME-92 COAT...
INFINION CX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 20, 2021
INFANT OXYGEN TREATMENT HOOD
FDA 510(k)
FDA Class 2
·Anesthesiology
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 2, 2021
BD VACUTAINER SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 22, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011
STRYKER PAIN PUMP
FDA Adverse Event
Injury
·STRYKER·Product code MEB·July 9, 2008
BIOLOX HEAD HIP IMPLANT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 25, 2019
UNKNOWN BIOLOX HEAD
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·February 13, 2018
CERASUL, HEAD, M/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·November 4, 2019
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