17 results · 26ms · Sources: EU EUDAMED, US FDA

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MUELLER HINTON AGAR

FDA 510(k)
FDA Class 2 ·Microbiology

EasyTouch

FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18019011·

n.a.

FDA UDI
Karl Storz GmbH & Co. KG·04048551202074·ROUX Retractor, small

N/A

FDA UDI
GEORGE TIEMANN & CO.·B5828019010·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Tasso+ Convenience Kit

FDA UDI
Tasso Inc.·00850038691011·

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136964·

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756086752·ARM SLING

IPL THERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135

FDA 510(k)
FDA Class 2 ·General Hospital

VENTED HIGH VOL. INLET, N/S

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - ENGLEWOOD·Product code LHI·March 20, 2017

TRI-LOCK BPS SZ 2 HI OFFSET

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 9, 2014

PRIMEADVANCED

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 23, 2012

MAGIC 3 FEMALE INTERMITTENT CATHETER

FDA Adverse Event
Malfunction ·ROCHESTER MEDICAL CORP.·Product code KOD·May 27, 2015

Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024