15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUPER SHEATH XL INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70601901·Mini-Mono-Brackets Roth 'N' .018" 20 Brackets
SPACELABS HEALTHCARE
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522123825·PACK,IEC LABELLED GROUPER,5/BG,96281
SSPIDERFX EMBOLIC PROTECTION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC INC/EV3 INC.·Product code NFA·December 17, 2018
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
FDA 510(k)
FDA Class 2
·Cardiovascular
SpiderFX
FDA UDI
Covidien LP·00821684040515·Embolic Protection Device
SpiderFX™
FDA UDI
EV3, INC·00821684068359·EP SPD2-US-060-190 SPIDER FX V04
ZKSK
FDA UDI
Beijing ZKSK Technology Co.,Ltd·06934415023443·Disposable Exsanguination Tourniquet
BIOLOX DELTA HEAD, 12/14, 32 X 0
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·April 11, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 4, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 15, 2011
SPIDERFX EMBOLIC PROTECTION DEVICE
FDA Adverse Event
Injury
·COVIDIEN·Product code NTE·August 19, 2014
TURBOHAWK PLAQUE PERIPHERAL EXCISION DEVICE
FDA Adverse Event
Injury
·COVIDIEN·Product code MCW·August 19, 2014
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024