24 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
RAD-G
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024
NA
FDA UDI
Synthes GmbH·10886982142788·2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
CODMAN
FDA UDI
Cerenovus, Inc.·10886704002116·CODMAN SLIM-LINE Aneurysm Clip Graft 3.5mm Diam...
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446894667·SPECIAL, EMPOWR - PHYSICA SHIFT BLOCK
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112397·BARD-PARKER HANDLE #9
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856044654·Ti ILIAC BONE SCREW ASSY, 8.5mm X 70mm X 30°
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856044647·TI ILIAC BONE SCREW ASSY, 8.5MM X 70MM X 15°
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2017700·2.4mm Cortex Screw, T8 Stardrive, Self-Tapping,...
Mini PCNL-System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A
FDA 510(k)
FDA Class 2
·Cardiovascular
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·January 14, 2018
VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 16, 2017
SYNCHROMED II
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 17, 2008
OLYMPUS EVIS EXERA II PEDI VIDEO COLONOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·June 28, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 5, 2011
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·January 8, 2018
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·February 8, 2018
SILK SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAP·November 16, 2017
ETHILON NYLON SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·November 16, 2017