19 results · 24ms · Sources: EU EUDAMED, 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