13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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The AIO Solution
FDA 510(k)
FDA Class 2
·Radiology
Life Instruments
FDA UDI
Life Instrument Corporation·M930719115800·Teardrop Curette 6mm Str
Life Instruments
FDA UDI
Life Instrument Corporation·M93071911580C0·Custom Teardrop Curette 11.5" 4.5" handle
LIC INSTRUMENT PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCALAR WAVE LASER SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191158310·Teardrop Curette Lateral Angle
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191158010·Teardrop Curette Straight
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191158110·11.5" Teardrop Curette, 8mm, 15 deg Ang, 4.5" h...
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 14, 2013
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 25, 2011
AUTOTOME RX SPINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·September 26, 2008
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018