17 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
FDA 510(k)
FDA Class 2
·Cardiovascular
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964006423·The ENDO CARRY-ON Procedure Kit contains all of...
PowerMidline
FDA UDI
Bard Access Systems, Inc.·00801741138713·Catheter Placement Kit
TEWA
FDA UDI
asia-med GmbH·04251282513443·TeWa DPB-Type 2213 Detox: coated acupuncture n...
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282506452·TeWa DPB-Type 2213 Detox: coated acupuncture n...
Journey
FDA UDI
Smith & Nephew, Inc.·00885556900215·LEGION CONSTRAINED INSERT W/
...
Xpeeda DSL Fiber
FDA UDI
LUMENIS LTD.·07290109140278·
EFFICIA DFM100
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.·Product code MKJ·March 24, 2025
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
FDA 510(k)
FDA Class 3
·Cardiovascular
VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·March 12, 2013
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·February 16, 2011
INTRATHECAL CATHETER
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·February 15, 2008
ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
FDA Enforcement
Class II
·Terminated·Invivo Corporation·September 14, 2016
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