36 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KYPHON VuE Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
BBL™ CultureSwab™
FDA UDI
COPAN ITALIA SPA·38053326001964·CultureSwab Amies Flexible Wire
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123208388·Crilewood Needle Holder OL 178mm (7")
Glover Coarctation Clamp angled 22cm
FDA UDI
Geister Medizintechnik GmbH·04057034052716·Glover Coarctation Clamp angled 22cm
LINK Instruments - Saw and drill guides
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575341252·Orthopaedic implant aiming/guiding block, reusa...
REGIUS SIGMA2
FDA 510(k)
FDA Class 2
·Radiology
VENUS UNIVERSAL LIGHT CURING COMPOSITE
FDA 510(k)
FDA Class 2
·Dental
LUNDERQUIST SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·May 13, 2026
ECHELON*FLEX60 ARTICULATING
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 23, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 3, 2014
FORTIFY ASSURA DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·May 11, 2026
LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·March 20, 2026
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·February 26, 2024
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
FDA Enforcement
Class II
·Terminated·Silk Road Medical Inc·March 3, 2021
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·January 1, 2020
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·November 26, 2025
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·November 27, 2025
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·September 5, 2025
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·January 3, 2023