24 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489105640·PowerChem Neoprene Exam Gloves, Large
GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040130541·Mirror Plane Cone Socket
PERMITE
FDA UDI
SDI LIMITED·DO3640014042·
PERMITE
FDA UDI
SDI LIMITED·09336472000318·PERMITE 1SP SLOW 50
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001404·artVeneer life upper anteriors, BOM, C4
Scanlan® TIP-GUARD™ instrument protectors - Vented
FDA UDI
SCANLAN INTERNATIONAL INC·00846159002171·Scanlan® TIP-GUARD™ instrument protectors - Ven...
Intervertebral Disc Preparation Instruments
FDA UDI
ALPHATEC SPINE, INC.·00190376380452·LIF, BROACH, STRAIGHT, 14MM X 04MM
Intervertebral Disc Preparation Instruments
FDA UDI
ALPHATEC SPINE, INC.·00190376380841·LIF, BROACH, CC OFFSET, 14MM X 04MM
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PC ECG 1200
FDA 510(k)
FDA Class 2
·Cardiovascular
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376646794·BROACH, LIF NAV, STRAIGHT, 14MM X 04MM
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.
FDA Recall
Terminated
·Optovue Inc.·Product code OBO·September 7, 2012
EPSILON DURASOL CONSTRAINED INSERT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWZ·March 7, 2013
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·February 25, 2011
APS II SMALL SHAVER HANDPIECE, FOOTSWITCH CONTROL
FDA Adverse Event
Other
·ARTHREX, INC.·Product code HRX·February 23, 2008
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.
FDA Enforcement
Class II
·Terminated·Optovue Inc.·October 31, 2012
Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Manufactured by: Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQL·November 19, 2009
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·October 3, 2018
Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130
FDA Recall
Terminated
·GE Medical Systems Information Technologies·November 16, 2000