14 results · 21ms · Sources: EU EUDAMED, 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