14 results
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30ms
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Sources: EU EUDAMED, US FDA
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
FDA 510(k)
FDA Class 2
·Radiology
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 3, 2020
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112359·SURG-I-BAND PURPLE GLOW
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122162·KWire .035x4" (0.9x100mm)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450210376·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450217016·
Alpine XC Adjustable Fusion System
FDA UDI
Highridge Medical, LLC·03662663196857·RACK DISTRACTOR TIP OFFSET L 9
METHAFILCON A
FDA 510(k)
FDA Class 2
·Ophthalmic
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MONTGOMERY TUBE
FDA Adverse Event
Death
·BOSTON MEDICAL PRODUCTS, INC.·Product code BTR·April 7, 2020
DPM 6/7 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
TOTALCARE SPO2RT
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 12, 2011
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016