22 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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REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664010645·BELLA STRONG 30-40 MM HG ARMSLEEVE DOT BAND SIZ...
PLATEAU-TL
FDA UDI
Life Spine, Inc.·00190837028299·PLATEAU-TL Interbody, Convex, Bulleted, 10mm x ...
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837010201·
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
HF-RESECTION ELECTRODE, FOR TURIS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·February 9, 2023
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024
IOLMASTER 500
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 2, 2013
PERCUTANEOUS THROMBOLYTIC DEVICE KIT
FDA Adverse Event
Malfunction
·ARROW INTERNACIONAL INC.·Product code MCW·August 27, 2014
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2011
NORIAN REINFORCED FAST SET PUTTY/3CC
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code GXP·May 19, 2015
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·March 28, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·December 28, 2022
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·April 27, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 21, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 21, 2023
HF-RESECTION ELECTRODE, ROLLER
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·April 28, 2023
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025