14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SURGICAL OBTURATOR WITH SEAL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tronex International, Inc.
FDA UDI
TRONEX INTERNATIONAL, INC.·10097604911730·Glove, Exam, Nitrile, Chemotherapy Rated, Finge...
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
FDA 510(k)
FDA Unclassified
·Unknown
SONOTT FLOWLAB(R)
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 31, 2018
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 18, 2018
SELUTE PICOTIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 11, 2013
PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT
FDA Adverse Event
Injury
·EV3 INC.·Product code FGE·November 23, 2010
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·March 8, 2022
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 10, 2019
VITEK® 2 GN TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LQM·September 17, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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