13 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TABLE, SAMPLE IL 461
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GBT Visigate
FDA UDI
IVOCLAR VIVADENT AKTIENGESELLSCHAFT·07615208473940·GBT Visigate Small / 60
Ceramill® ZI
FDA UDI
Amann Girrbach AG·E4947602331·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110591·COAXIAL IRRIGAT-ASPIRAT TIP 90 DEG ASP
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110577·COAXIAL IRRIGATING/ASPIRATING TIP CURVED
Performa®
FDA UDI
Merit Medical Systems, Inc.·00884450010327·
TEST, ANTIBODIES FOR GRP A, LATEX SLIDE
FDA 510(k)
FDA Class 1
·Microbiology
TROKAMED GMBH ENDOSCOPES AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EPIDURAL MINIPACK SYSTEM 1 WITH LOCKIT PLUS FIXATION DEVICE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code OGE·April 26, 2019
COREVALVE 31MM AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 18, 2014
UNKNOWN CALAXO SCREW
FDA Adverse Event
Other
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·June 22, 2007
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 8, 2015
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025