10 results
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21ms
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Sources: EU EUDAMED, US FDA
DISPOSIBLE EEG NEEDLE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
LARGE CUP BIOPSY FORCEPS INSERT
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929012800·LARGE CUP BIOPSY FORCEPS SINGLE-ACTION JAWS FOR...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111230950·SIMS SCISS STR S/S 8"
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
FDA 510(k)
FDA Class 1
·General Hospital
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·November 9, 2010
PELVICOL 6X8 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·November 16, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 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
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021