24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUTTING EDGE SPINE INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
ADULT FLOW PROBE 3/8" X 3/32"
FDA UDI
Thoratec Switzerland GmbH·07640135140139·
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY·Product code FOZ·September 18, 2024
TOWEL DRAPE, MODELS 4409, 4410
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLAR SPO2 MODULE WITH MASIMO SET
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INSYTE-N AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY·Product code FOZ·September 18, 2024
INSYTE AUTOG BC WING PNK 20GA X 1.0IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·December 11, 2024
PRECISION XTRA
FDA Adverse Event
Injury
·Product code NBW·May 9, 2013
DURA DURATION A/P TIB SM 13
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·September 19, 2014
PROTIME MICROCOAGULATION SYSTEM
FDA Adverse Event
Malfunction
·INTERNATIONAL TECHNIDYNE CORPORATION·Product code JPA·May 4, 2011
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 6, 2024
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 7, 2024
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 6, 2024
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 7, 2024
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 6, 2024
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 7, 2024
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·September 5, 2023
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
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021