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

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IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

FDA 510(k)
FDA Class 2 ·Immunology

M2376A DEVICELINK SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIOABSORBABLE INTERFERENCE SCREW MEGAFIX

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 19, 2024

CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM

FDA Adverse Event
Malfunction ·AESCULAP, INC.·Product code GEI·April 15, 2015

OT VERIO IQ METER

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

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011

NOVOTWIST 8 MM (30G)

FDA Adverse Event
Injury ·NOVO NORDISK A/S, MS HJOERRING·Product code FMI·August 11, 2016

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