19 results · 26ms · Sources: EU EUDAMED, US FDA

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CUTTERSIL ACTIVATOR UNIVERSAL PLUS

FDA 510(k)
FDA Class 2 ·Dental

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014605845·AMSCO 3080/3085 3PC PAD SET 2 1/4 DELUXE W/GEL

VITAPORT 3

FDA 510(k)
FDA Class 2 ·Neurology

ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200

FDA 510(k)
FDA Class 2 ·Cardiovascular

RD SET YI

FDA Adverse Event
Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

M-LNCS DC-I

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·March 16, 2019

M-LNCS DC-I

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

RADICAL-7

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·February 19, 2016

RAD-57 CONFIGURABLE PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·June 24, 2019

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2013

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Malfunction ·COCHLEAR LTD.·Product code MCM·May 6, 2011

LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·July 24, 2008

RAINBOW RC-4

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 11, 2017

RD SET

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

RD SET

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·August 29, 2019

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014