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