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

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URONIRS, MODEL 2000

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

Specials

FDA UDI
Seaspine Orthopedics Corporation·10889981297916·Graft Delivery Pusher, Short

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 7, 2024

POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)

FDA 510(k)
FDA Class 2 ·Hematology

INSET II

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A DE C.V·Product code FPA·April 21, 2026

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

TOTAL ASR FEM IMP SIZE 53

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KXA·April 29, 2013

HEARTSTART MRX-EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 28, 2011

PIC

FDA Adverse Event
Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·July 21, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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