17 results · 24ms · Sources: EU EUDAMED, US FDA

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V SCORE WITH AUTO GATE MODEL TBD

FDA 510(k)
FDA Class 2 ·Radiology

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964022706·The ENDO CARRY-ON Procedure Kit contains all of...

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085020457·Gram Stain QC Slide

SCANLAN® Needle Holders

FDA UDI
SCANLAN INTERNATIONAL INC·00846159019155·Jacobson Micro Needle Holder Flat Handle

FacetFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361020028·Facet Screw Assy, SOTW, 5.5 x 30mm

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002

FDA 510(k)
FDA Class 2 ·Cardiovascular

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·Product code KDJ·February 28, 2011

ALLEN MEDULLARY CEMENT PLUGS

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code LOD·February 21, 2008

EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230

FDA Recall
Open, Classified ·Qiagen Sciences LLC·Product code JJH·March 4, 2024

EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230

FDA Enforcement
Class II ·Ongoing·Qiagen Sciences LLC·April 17, 2024

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

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 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