16 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RADIANCE V2
FDA 510(k)
FDA Class 2
·Radiology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606258·SPACER 2133655 OLIF25 27MM 18 DEG 18X55
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027735·
SYRINGE PLASTIPAK 3ML S/SU
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·August 17, 2020
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 26, 2019
ACCESS ACCUTNI
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·October 1, 2014
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·May 29, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 7, 2015
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·August 17, 2023
BD PLASTIPAK LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·August 26, 2021
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·April 8, 2025
TI-SU03 GC
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
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