16 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756349154·OPEN HEART PACK
Bone Screws
FDA UDI
ORTHOFIX SRL·18033509850486·CORTICAL SCREW 70/20 MM STERILE SHAFT D 6MM THR...
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112250·SURG-I-BAND YELLOW
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820097·Spark™ TruColor™ headlight system - Internation...
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820110·Spark™ TruColor™ headlight system - Internation...
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820127·Spark™ TruColor™ headlight system - China, Type...
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820080·Spark™ TruColor™ headlight system - Internation...
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820073·Spark™ TruColor™ headlight system - North Ameri...
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820103·Spark™ TruColor™ headlight system - Internation...
WV1 Endoscope
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
FDA 510(k)
FDA Class 2
·Cardiovascular
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·November 30, 2010
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·July 2, 2014
FLOWTRON EXCEL / TRIO PUMPS
FDA Adverse Event
Malfunction
·GETINGE (SUZHOU) CO. LTD.·Product code JOW·November 23, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024