12 results
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20ms
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Sources: EU EUDAMED, US FDA
BUN, ENZYMATIC
FDA 510(k)
FDA Class 2
·Clinical Chemistry
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471183205·.022 L/L Std. Weld Size #15
Acuson SC2000 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 7, 2014
CAPTURE-R READY-SCREEN (3)
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·October 3, 2012
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·July 21, 2010
STANDARD INSERTION HANDLE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 14, 2013
HOLDING DEVICE FOR GUIDE WIRESAND REAMING RODS
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·June 14, 2013
AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·June 14, 2013
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc., an AngioDyamics Company·June 22, 2016
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