14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blue Sky Bio Zygomatic Implant System
FDA 510(k)
FDA Class 2
·Dental
Oticon
FDA UDI
Oticon A/S·05707131338945·SIYA 2, BTE 13 PP 2.4G 105 C091
COMPOSITCP RESORBABLE INTERFERENCE SCREW
FDA Adverse Event
Malfunction
·S.B.M. SAS·Product code HWC·October 4, 2021
BACKSTOP CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DSS STABILIZATION SYSTEM-RIGID
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 11, 2024
INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 16, 2024
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 21, 2014
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
MAMBA? FLEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
FDA Enforcement
Class II
·Completed·SCIENCE & BIO MATERIALS·July 20, 2022
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024