14 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
FDA 510(k)
FDA Class 1
·General Hospital
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085022062·Nocardia/Actinomyces Counterstain 1x250ml
Integra®
FDA UDI
Ascension Orthopedics, Inc.·10381780241560·Integra® Total Foot System
The drill guide is u...
BD 10ML SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 14, 2020
SENTRY EXPANDING INTRODUCER SHEATH (EIS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PIPET CURET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AS LVP 20D 2SS CV
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·December 15, 2020
SILTEX ROUND MOD. PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR MEDICAL SYSTEM B.V.·Product code FTR·December 7, 2021
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 11, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 1, 2011
EASY LOAD INSERTER
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code KYB·February 26, 2008
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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