20 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BD TRITEST CD3/CD4/CD45, MODEL 340383
FDA 510(k)
FDA Class 2
·Hematology
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496071143·MISS RELAX 140 SHEER, SIZE XL, GLACE, GRADUATED...
ConMed Linvatec
FDA UDI
Provision·B504OM50711430·
NA
FDA UDI
STERILMED, INC.·10888551020442·SAW BLADE OSCILLATING LARGE BONE
ME-92
FDA UDI
Conmed Corporation·10845854002377·OSCILLATOR BLADE, ME-92 COATED, 25.4 X 90 X 0.8...
TINA-QUANT D-DIMER TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 22, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 27, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008
NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code LZO·September 13, 2023
FREESTYLE INSULINX
FDA Adverse Event
Malfunction
·Product code NBW·April 10, 2013
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
FDA Enforcement
Class I
·Terminated·Abbott Diabetes Care, Inc.·May 15, 2013
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018