20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BREATHABLE SURGICAL GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DRX - Ascend System
FDA UDI
CARESTREAM HEALTH, INC.·60889971023162·DRX-ASCEND SYSTEM/QG-40-2-R10-T140
NA
FDA UDI
Conmed Corporation·10845854005996·MICRO OSCILLATOR BLADE, FINE, 5.5 X 13 X 0.4 MM...
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500
FDA 510(k)
FDA Class 2
·Neurology
audifon
FDA UDI
audifon GmbH & Co. KG·EADF023167903931317201·RITE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF023167903932517201·RITE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF023167903933217201·RITE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF023167903931217201·RITE-TRT
ISA CO2
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·February 27, 2013
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·February 15, 2011
REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE LTD·Product code FRN·April 3, 2008
ABRE VENOUS SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code QAN·April 3, 2025
ABRE VENOUS SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code QAN·April 3, 2026
ABRE VENOUS SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Death
·COVIDIEN·Product code QAN·April 3, 2026
ABRE VENOUS SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code QAN·April 3, 2026
ABRE VENOUS SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code QAN·April 3, 2025
ABRE VENOUS SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Death
·COVIDIEN·Product code QAN·April 3, 2025
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