18 results · 24ms · Sources: EU EUDAMED, US FDA

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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