18 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ESTELITE COLOR
FDA 510(k)
FDA Class 2
·Dental
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433132·Integra® Jarit® Knife Handle No. 3L, 8-1/4", Ho...
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODIFICATION TO INTEL HEALTH GUIDE PHS6000
FDA 510(k)
FDA Class 2
·Cardiovascular
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·June 23, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 25, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 21, 2014
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC.·Product code MUJ·July 28, 2021
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013
REACH OVERTUBE
FDA Adverse Event
Malfunction
·UNITED STATES ENDOSCOPY GROUP·Product code FED·September 11, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·May 19, 2011
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC·Product code MUJ·August 25, 2021
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 24, 2024
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024