12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Endo Ultrasonic Activator
FDA 510(k)
FDA Class 2
·Dental
Bernafon
FDA UDI
Bernafon AG·05714464009046·AO9 MNR T R SABE/MSIL ALIGO 9 GPL
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·June 18, 2025
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 7, 2019
MATRIX DETACHABLE COIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code HCG·November 5, 2008
CELL-DYN 3200 CS 110V ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 24, 2011
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 2, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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