19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AQUACEL AG SURGICAL
FDA 510(k)
FDA Unclassified
·Unknown
1049092-2018-00287
FDA Adverse Event
Injury
·Product code FRO·May 15, 2018
9618003-2021-01239
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021
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
LEONE SPA
FDA UDI
LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450221587·
Orthopedic Instruments
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258660912·
MODEL APS ALTERNANS PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 13, 2025
3002 MASTER BOMS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 11, 2011
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·May 3, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
ENCOREANYWHERE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 17, 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