14 results · 19ms · Sources: EU EUDAMED, US FDA

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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