15 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MEDUSA VASCULAR PLUG

FDA 510(k)
FDA Class 2 ·Cardiovascular

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564039415·LP GOWNS, LG 24 PK N/S

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00810019800863·Gown, L4 LG, 24-Pack NS

OPTOS ADVANCE

FDA 510(k)
FDA Class 2 ·Radiology

ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 18, 2019

VERTEX® RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2017

VERTEX® RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·October 18, 2018

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 22, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 26, 2014

INSYNC SENTRY

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011

VERTEX® RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 17, 2017

VERTEX® RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 15, 2024

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024