10 results · 18ms · Sources: EU EUDAMED, US FDA

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CYCLOPAC TENS

FDA 510(k)
FDA Class 2 ·Neurology

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136292·

Symmetry Jones

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031940·Symmetry® Scissors, Jones, IMA, Bayonet, Angled...

IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

PROFAST+ ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2014

N/A

FDA Adverse Event
Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS·Product code NLQ·October 23, 2012

INTEGRATED APD SET W/CASSETTE3-PRONG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2010

Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

FDA Enforcement
Class I ·Ongoing·Zyno Medical LLC·June 18, 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