17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
Endo GIA
FDA UDI
Covidien LP·10884523002928·Universal Loading Unit
Ormco
FDA UDI
ORMCO CORPORATION·00889989075922·BIRD BEAK PLIERS
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482051030·Symmetry® Scissors, Operating, Straight, Sharp/...
POLARIS
FDA UDI
HNM TOTAL RECON LLC·00841742113449·POLARIS ø3.2mm/ø2.5mm Micro High Compression Sc...
MEDISUL DISPOSABLE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
FDA 510(k)
FDA Class 2
·Immunology
CARTRIDGE
FDA Adverse Event
Injury
·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·November 29, 2024
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 2, 2013
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·March 7, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 15, 2008
EGIA ULTRA UNIVERSAL STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·April 30, 2015
EEA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·November 7, 2022
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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016