15 results · 22ms · Sources: EU EUDAMED, US FDA

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SAS INFLUENZA A & B TEST

FDA 510(k)
FDA Class 2 ·Microbiology

Mapleson Anesthesia Breathing Circuit

FDA UDI
MERCURY ENTERPRISES, INC.·10641043803806·

BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code JKA·July 6, 2022

BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 19, 2022

FOTOMASTER

FDA 510(k)
FDA Class 2 ·Radiology

MP3HD BIG BOY, POWER WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·November 19, 2019

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·November 19, 2019

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·April 26, 2013

PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·May 6, 2011

ACUVUE ADVANCE FOR ASTIGMATISM

FDA Adverse Event
Injury ·VISTAKON·Product code LPL·July 21, 2008

HARMONIC SCALPEL CURVED SHEARS

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·November 27, 2019

ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·August 29, 2019

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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015