8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102893·JAFFE-BECHERT ROTATOR 9MM
SNORENTI
FDA 510(k)
FDA Class 2
·Dental
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 1, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 17, 2010
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·January 17, 2013
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016