11 results · 23ms · 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, GREEN COLOR

FDA 510(k)
FDA Class 1 ·General Hospital

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033544792·

CAPNOPROBE SL, MODEL 2000

FDA 510(k)
FDA Class 2 ·Anesthesiology

BIOLUCENT MAMMOGRAPHY CUSHION

FDA 510(k)
FDA Class 2 ·Radiology

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code ITI·March 20, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·March 10, 2011

SILICONE ADVANCED OPTIC LENS

FDA Adverse Event
Injury ·BAUSCH & LOMB·Product code HQL·March 14, 2008

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025

UNK - CONSTRUCTS: LCP DISTAL HUMERUS

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HRS·May 15, 2026

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