13 results · 20ms · Sources: EU EUDAMED, US FDA

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3D ENDOSCOPE

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

COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

FDA 510(k)
FDA Class 2 ·Microbiology

MINIMED SILHOUETTE

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·May 16, 2025

NA

FDA UDI
Zimmer, Inc.·00889024065536·

BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·April 10, 2019

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·March 13, 2013

COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 28, 2011

PRISM 2000 GAMMA CAMERA

FDA Adverse Event
Other ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code IYX·February 8, 2008

24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 5, 2019

BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE

FDA Adverse Event
Injury ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·May 16, 2019

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

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024