14 results · 21ms · Sources: EU EUDAMED, US FDA

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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