17 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WG-SURGICAL SUTURES WITH NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACTERA FEMORAL BROACH, SIZE 09
FDA UDI
Conformis, Inc.·00810933031527·ACTERA FEMORAL BROACH, SIZE 09
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RX HERCULINK PLUS BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 1, 2022
SYRINGE 20ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·June 7, 2025
CADD - SOLIS AMBULATORY INFUSTION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD·Product code MEA·April 8, 2013
OPTIBOND FL
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 6, 2011
9616240-2008-00037
FDA Adverse Event
Injury
·Product code FII·July 11, 2008
BD SYRINGE 20ML LL BNS
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·December 10, 2025
SYRINGE 20ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 14, 2025
VERCISE PC
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·January 11, 2022
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
FDA Recall
Open, Classified
·Datascope Corporation·Product code DSP·July 27, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
FDA Enforcement
Class II
·Ongoing·Datascope Corporation·September 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Enforcement
Class II
·Ongoing·Datascope Corporation·September 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Recall
Open, Classified
·Datascope Corporation·Product code DSP·July 27, 2020
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014