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