17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ambu Duodeno System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446270065·Special, AltiVate Anatomic Cannulated Ream-Run ...
LIPOSUCTION CANNULA
FDA UDI
SONTEC INSTRUMENTS, INC.·B0992010980·LIPOSUCTION CANNULA WITH TWO HOLES CURVED
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
FDA 510(k)
FDA Class 2
·General Hospital
DAUM-LECTRIC MRI DRILLING MACHINE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CLICKFINE 32GX4MM DONGBAO 7CT
FDA Adverse Event
Malfunction
·YPSOMED AG·Product code FMI·November 9, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 27, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 11, 2011
TI NUT 11MM WIDTH ACROSS FLATS
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWQ·July 2, 2013
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021
BD PHASEAL OPTIMA INJECTOR (N40-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 15, 2019
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 21, 2021
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021