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

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WALK400H

FDA 510(k)
FDA Class 2 ·Cardiovascular

LEONE SPA

FDA UDI
LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450210253·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450224106·

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated

RADS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER

FDA 510(k)
FDA Class 2 ·Radiology

1049092-2018-00287

FDA Adverse Event
Injury ·Product code FRO·May 15, 2018

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

9618003-2021-01239

FDA Adverse Event
Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021

PRONTO SPOT CHECK PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 9, 2018

ACCUTORR PLUS MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 11, 2011

Dressing, wound, drug

FDA Adverse Event
Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·September 9, 2021

9618003-2021-01006

FDA Adverse Event
Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·May 28, 2021

9618003-2021-01210

FDA Adverse Event
Injury ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021

Dressing, wound, drug

FDA Adverse Event
Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·October 17, 2022

9618003-2022-00003

FDA Adverse Event
Injury ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·January 6, 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