13 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614131·Sprint II Bracket Roth .018" mand. 3 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614130051·Sprint II Bracket Roth .018" mand. 3 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614131001·Sprint II Bracket Roth .018" mand. 3 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78614130101·Sprint II Bracket Roth .018" mand. 3 right
Low Profile Balloon Feeding Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
SPRINT QUATTRO SECURE MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 8, 2010
FOUNDATION SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·November 29, 2012
Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012