11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Maximus System
FDA 510(k)
FDA Class 2
·Anesthesiology
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032931·ET20, KIT 312 2.4G NFM PB L BE ENCHANT 20
SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
VSP SYSTEM
FDA Adverse Event
Injury
·3D SYSTEMS·Product code DZJ·December 18, 2020
SYSTEM 7 DUAL TRIGGER ROTARY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·June 27, 2013
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 4, 2011
ORAL B
FDA Adverse Event
Injury
·ORAL B LABORATORIES·Product code JES·October 7, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·November 5, 2011
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018
Philips Zenition 70, Model Number: 718133
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024