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

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LEGEND ALL-POLY CUP

FDA 510(k)
FDA Class 2 ·Orthopedic

MATIRA ANTERIOR CERVICAL SYSTEM

FDA UDI
Kalitec Direct LLC·B07307K0154071·TRIAL, DRILL GUIDE 14 X 11, 7 MM TA

Acapella One

FDA UDI
Choice Spine, LP·00840996150705·ACAPELLA,TRIAL,LR,NS,12X14X7

LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO

FDA 510(k)
FDA Class 1 ·General Hospital

SURGITRON IEC II

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 4, 2025

CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·April 10, 2013

MOBILE TREAT. REC. LY5007

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FRK·April 4, 2011

ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

FDA Adverse Event
Malfunction ·COVIDIEN·Product code DXT·May 16, 2008

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010

ARCHITECT ANTI-TPO

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 11, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 16, 2025

ARCHITECT ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JZO·May 23, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·March 17, 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