17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FALLER STYLET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925018501·MCGEE FOOTPLATE HOOK ANTERIOR .50 MM TIP LENGTH...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450385395·
XINIWAVE, MODEL XW-18
FDA 510(k)
FDA Class 2
·Neurology
SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 12 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2018
CORDLESS DRIVER 3
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·May 24, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·September 30, 2014
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 16, 2011
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·October 30, 2017
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 9, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·February 28, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 8, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·April 25, 2018
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
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025