13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RAPID-I
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoughAssist
FDA UDI
Respironics, Inc.·00606959021211·CoughAssist 70 Series Circuit, Adult Small, 6 ft
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450047903·
STEROTACTIC LOCALIZATION DEVICE (SLD)
FDA 510(k)
FDA Class 2
·Radiology
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NDN·March 14, 2018
S5 CONSOLE FOR 4 PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 1, 2010
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIO·May 2, 2013
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
RESPIRONICS INC·Product code BTI·September 15, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·May 10, 2011
BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·July 26, 2017
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024