22 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
FDA 510(k)
FDA Class 2
·General Hospital
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446929833·SPECIAL, TAPERFILL BIPOLAR TRIALS, NEUTRAL, SM
StarDental Instrument Solutions
FDA UDI
DENTALEZ, INC.·D7022019360·INSTR MG DE MCCAL 13S-14S
Conventional Lead Apron .5mm Large 24 X 42
FDA UDI
Flow X Ray Corporation·00843696123512·Conventional Lead Apron .5mm Large 24 X 42, Hun...
MICROETCHER
FDA UDI
DANVILLE MATERIALS, LLC·00816594021532·MICROETCHER CD, KAVO
MOIST PUNCTAL PLUG SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HUMELOCK REVERSED
FDA Adverse Event
Injury
·FX SOLUTIONS·Product code PHX·March 16, 2020
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025
DESARA
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code OTN·October 20, 2014
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013
UNK - CONSTRUCTS: USS II
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code MNH·May 26, 2021
UNK - SCREWS: ASLS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·November 27, 2024
SOLITAIRE FR2
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·June 20, 2022
UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·October 1, 2021
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·February 12, 2019
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·July 1, 2019
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