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