16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA
FDA UDI
STERILMED, INC.·10888551020459·SAW BLADE OSCILLATING LARGE BONE
Up&Up
FDA UDI
TARGET CORPORATION·00014007478779·Black Pre-Cut Kinesiology Tape - 2in x 10in - U...
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
FDA 510(k)
FDA Class 2
·Hematology
CADENCE PHYSIO QC ADULT RTS
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MLN·April 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 27, 2011
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
FREESTYLE INSULINX
FDA Adverse Event
Malfunction
·Product code NBW·April 10, 2013
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
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
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
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