17 results · 22ms · Sources: EU EUDAMED, 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