20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AEI DR. TERAUCHI ULTRASONIC TIPS
FDA 510(k)
FDA Class 2
·Dental
Likorall™ overhead lift
FDA UDI
Liko AB·00887761979482·Overhead track patient lifting/transfer system
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780377696·Integra® Jarit® Adson Needle Forceps, 4-3/4", C...
TIGER Spine System
FDA UDI
CORELINK LLC·M7256122501·5500 SERIES CONNECTOR - LEFT OFFSET, POLY-AXIA...
TIGER Spine System
FDA UDI
CORELINK LLC·M72561225010·5500 SERIES CONNECTOR LEFT OFFSET, POLY-AXIAL S...
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 12, 2019
NA
FDA UDI
Summit Medical, Inc.·00385640002202·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867175136·Suture Cutter, Top Release
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166848·Initia Acetabular Standard Liner, E-CIMA 22-50
VENUS PEARL PLT REFILL A1
FDA 510(k)
FDA Class 2
·Dental
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 22, 2024
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·May 15, 2013
TERUMO STERNAL SAW II
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·September 22, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011
MALIBU
FDA Adverse Event
Injury
·SEASPINE INC.·Product code NKB·February 12, 2020
MALIBU
FDA Adverse Event
Injury
·SEASPINE INC.·Product code NKB·February 12, 2020
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·March 23, 2022
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021