84 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02)
FDA 510(k)
FDA Class 2
·Cardiovascular
NeoFuse Ti3D PLIF/TLIF
FDA UDI
XENIX MEDICAL LLC·00818345021594·Ti3D CAGE 24L x 12W x 7H
NeoFuse HA Enhanced PLIF/TLIF
FDA UDI
XENIX MEDICAL LLC·00818345020511·HA CAGE 24L x 12W x 7H
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522412070·
ELMED
FDA UDI
ELMED INCORPORATED·00842180186330·BAYLOR SUMP TUBE LARGE, TIP 6.4MM OD ANGLED 90°...
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NOVABONE BIOACTIVE STRIP
FDA 510(k)
FDA Class 2
·Orthopedic
EON MINI 16 - CHANNEL RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 17, 2011
SP2 TIBIAL RADEL IMPACTOR
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·November 10, 2014
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·July 22, 2013
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 8, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·October 15, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FMI·December 3, 2025
BD VACUTAINER® SERUM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·January 26, 2026
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A
FDA Enforcement
Class II
·Ongoing·Zimmer Surgical Inc·February 4, 2026
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·November 17, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FMI·November 20, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 8, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 8, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FMI·December 8, 2025