22 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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APOLLO
FDA 510(k)
FDA Class 2
·Radiology
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911050190·INHALATION SET, TRACH,AIR-LON - SIZE 8
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111702·Modular Stem 19mm x 100mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192572·Distal Reamer 19mm (Zimmer)
CENTERS FOR DISEASE CONTROL AND PREVENTION
FDA registration
CENTERS FOR DISEASE CONTROL AND PREVENTION·16 products·🇺🇸 United States
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
FDA 510(k)
FDA Class 2
·Cardiovascular
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
T-FLEX ASPHERIC
FDA Adverse Event
Malfunction
·RAYNER INTRAOCULAR LENSES LTD.·Product code HQL·April 4, 2013
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 5, 2011
WINGSPAN STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION·Product code NJE·May 23, 2008
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
BD FACS 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020
2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·February 28, 2023
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025
Tracheostomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050180 size 3, item number 1050182 size 4, item number 1050184 size 5, item number 1050186 size 6, item number 1050188 size 7, and item number 1050190 size 8.
FDA Recall
Terminated
·Premier Dental Products Co·Product code JOH·August 5, 2004
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Recall
Open, Classified
·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025