23 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58280109060·
PediPlates
FDA UDI
ORTHOPEDIATRICS CORP.·00841132133941·PEDIPLATE LP SCREW CADDY
neoWave C
FDA UDI
XENIX MEDICAL LLC·00840493415024·Rasp, Universal
TiWAVE C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07320K0100060·Rasp, Universal
PediPlates
FDA UDI
ORTHOPEDIATRICS CORP.·00841132135884·PEDIPLATE LP SCREW CADDY
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100060·Tray Insert, Lumbar Screws, 10 x 10 Assembly
KLINIDRAPE SURGICAL DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECSYS INSULIN CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AUTOSOFT 90
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 19, 2025
AUTOSOFT 90
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 19, 2025
AUTOSOFT 90
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 19, 2025
MEDSTONE LITHOTRIPTOR
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code LNS·June 12, 2017
TOTALCARE BED
FDA Adverse Event
Injury
·HILL-ROM, INC.·Product code FNL·March 8, 2013
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·March 4, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
RUBY COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·May 18, 2021
RUBY COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·May 18, 2021
Citation AT Femoral Stem
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code MAY·August 24, 2005
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