14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
FDA 510(k)
FDA Class 1
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450595145·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033544860·
BRIDGE III RECEIVER
FDA 510(k)
FDA Class 2
·Cardiovascular
ELISA TEST, SEROLOGY
FDA 510(k)
FDA Class 1
·Microbiology
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL S.A DE C.V·Product code FPA·October 22, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 20, 2013
CVC KIT: 2-LUMEN 7 FR X 60 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQY·February 4, 2011
EASY LOAD INSERTER
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·March 14, 2008
IMPL TWIST MTX 3.75 MM 10 MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 17, 2024
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V·Product code FPA·October 7, 2025
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022