14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
FDA 510(k)
FDA Class 2
·Anesthesiology
PASCAL DYNAMIC CONTOUR TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2
FDA 510(k)
FDA Class 2
·Neurology
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 21, 2022
FLOCONTROL ARTHROSCOPY PUMP
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code HRX·October 1, 2014
HYDROVIEW INTRAOCULAR LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·May 23, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 17, 2011
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 1, 2023
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·September 30, 2025
REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·June 20, 2024
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024