14 results · 25ms · Sources: EU EUDAMED, US FDA

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PARAGON INFUSION SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001342·Cervical Collar

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743649·ACHIMED ACHILLES SUPP SILVER I

Midway Select

FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717102458·Midway Select Imp Mat'l Reg/Mono Reg Set

UD-1000 ULTRASONIC A/B SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

SPECTRUM SILICONE FOLEY CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BD INSYTE¿ IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 23, 2018

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·March 25, 2013

ORAL / ENTERAL SYRINGE

FDA Adverse Event
Other ·PHILIPS RESPIRONICS, INC.·Product code KYZ·March 11, 2011

VITROS ECI IMMUNODIAGNOSTICS SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·March 26, 2008

COMP PRIMARY STEM 8MM MINI

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBF·July 9, 2021

UNKNOWN HUMERAL BEARING

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·July 9, 2021

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

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