18 results · 30ms · Sources: EU EUDAMED, 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