13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PECD-01 AND PECD QUICK-01
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827868·***DISC*LEVAMED ANKLE SUPPORT BLACK IV
LEONE SPA
FDA UDI
LEONE SPA·08033707001102·STANDARD SCREWS S/STEEL 14mm UPPER
iTotal Alignment Rod Taper 150mm
FDA UDI
Conformis, Inc.·00810933030353·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306815249·Olsen-Hegar Needle Holder, Serrated Jaws, 14cm
Azur Pure Helical
FDA UDI
Microvention, Inc.·00810170018190·Azur
PULPDENT GLAZE II
FDA 510(k)
FDA Class 2
·Dental
RUMBAR DRAINAGE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BRILLIANCE 16 AIR
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·April 24, 2013
LIGHTSPEED VCT
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011
MTOME ST HOLSTER/CABLES
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code KNW·July 24, 2008
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 24, 2014
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014