16 results · 22ms · Sources: EU EUDAMED, US FDA

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VERTOS MEDICAL MILD DEVICE KIT

FDA 510(k)
FDA Class 2 ·Orthopedic

BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BACTEC MGIT 960 SIR KITS

FDA 510(k)
FDA Class 2 ·Microbiology

GEM SPLT SET Y-EXT BCXCHK 282CM (50EA/CS)

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014

GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014

GEM SPLT SET Y-EXT BCKCHK 282CM

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 23, 2014

GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·November 27, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

MX40 2.5 GHZ SMART HOPPING

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DSI·September 10, 2014

DUAL CUT SAGITTAL BLADE

FDA Adverse Event
Malfunction ·STRYKER IRELAND LTD.·Product code GFA·April 15, 2011

BD BACTEC¿ MGIT¿ 960 SIRE KIT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·May 6, 2022

BD BACTEC¿ MGIT¿ 960 SIRE KIT

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·June 30, 2025

BD BACTEC¿ MGIT¿ 960 SIRE KIT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 19, 2023

BD BACTEC¿ MGIT¿ 960 SIRE KIT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 26, 2022

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

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018