10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ABBOTT TESTPACK CHLAMYDIA
FDA 510(k)
FDA Class 1
·Microbiology
Gill
FDA UDI
The Radebaugh-Fetzer Company·00850047707062·G-1617-6 Wester-Pattern Stainless Steel Nail Ni...
ALSEVER'S SOLUTION (MODIFIED)
FDA 510(k)
FDA Class 1
·Hematology
AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
ANTI-SIPHON PCA EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FRN·February 4, 2011
The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders.
FDA Recall
Terminated
·Ventus Medical, Inc.·Product code MNR·December 3, 2009
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025