18 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WORK SIMULATOR
FDA 510(k)
FDA Class 1
·Physical Medicine
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950022373·CALIPER JAMESON 4" 10CM
Mini Standard Edgewise
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746067266·DB BKT MINI STANDARD EDGEWISE LOW LOWER ANT 022...
Enthus
FDA UDI
DHARMA RESEARCH, INC.·00353045001830·Enthus VPS Impression Material, Light Body, Fas...
0800,APS1,12,N,VL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828152723·0800,APS1,12,N,VL
Trimline
FDA UDI
ORMCO CORPORATION·00889989051117·UPPER LEFT FIRST MOLAR TRIMLINE BAND SIZE 7
LP Low Profile
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746122910·DB BKT LP STANDARD EDGEWISE MAND ANTERIOR 022 ...
Rampart O
FDA UDI
SPINEOLOGY INC.·M7402800007·13x25mm Trial
GRADUATED ADAPTER WITH CLAVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·August 6, 2021
PROGRAMMING COMPUTER
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·May 8, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 17, 2012
RENEW SINGLE RECEIVER, 8-CHANNEL
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code GZB·August 12, 2010
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
FDA Recall
Terminated
·Abbott Laboratories Inc. (St Jude Medical)·Product code DQK·May 5, 2021
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
FDA Enforcement
Class II
·Terminated·Abbott Laboratories Inc. (St Jude Medical)·June 23, 2021
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 10, 2025
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025