15 results
·
18ms
·
Sources: EU EUDAMED, US FDA
A.V. FISTULA CANNULATION SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LEONE SPA
FDA UDI
LEONE SPA·08033707028345·WEB 1ST MOLAR BANDS n.UL 21
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88300211·Max. 1. Molar band W-Fit right 21
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209122837·KIT, SUPRAPUBIC CATHETERIZATION
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88300210101·Max. 1. Molar band W-Fit right 21
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88300210051·Max. 1. Molar band W-Fit right 21
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88300210501·Max. 1. Molar band W-Fit right 21
Persona®
FDA UDI
Zimmer, Inc.·00889024563094·
PHILIPS HERCEPTEST DIGITAL SCORE
FDA 510(k)
FDA Class 2
·Hematology
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SERVO
FDA Adverse Event
Injury
·SIEMENS·Product code CBK·May 19, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code NEP·November 13, 2012
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 3, 2010
DREAMSTATION AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS INC·Product code BZD·September 26, 2022
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015