13 results · 20ms · Sources: EU EUDAMED, US FDA

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PONTIC PAINT

FDA 510(k)
FDA Class 2 ·Dental

ArgenZ ST 95x16 ML A2B

FDA UDI
ARGEN CORPORATION, THE·D818130237·Dental porcelain/ceramic restoration kit

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180623·Integra® Jarit® Adson Forceps, 4-5/8", Angled, ...

N/A

FDA UDI
Tyber Medical, LLC·M695M1302370·

DIALYSATE METER, MODEL D-6

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

BD WHITACRE SPINAL NEEDLE

FDA Adverse Event
Injury ·BECTON DICKINSON·Product code BSP·March 27, 2007

UNKNOWN GUIDING CATHETER CARDIOLOGY

FDA Adverse Event
Injury ·CORDIS CORPORATION·Product code DQY·April 30, 2019

SECURE 3 MED/SURG BEDOBS 01/13

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 18, 2014

CAPSUREFIX

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

OMNIPOD INSULIN MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·May 1, 2020

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