14 results · 21ms · Sources: EU EUDAMED, US FDA

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RHEUMELISA II SCL-70 ANTIBODY TEST KIT

FDA 510(k)
FDA Class 2 ·Immunology

Invictus

FDA UDI
ALPHATEC SPINE, INC.·00190376309125·Cross Connector, Head to Head, 30mm

Cranial Fusion Plate System

FDA UDI
Life Spine, Inc.·00190837031374·30mm Plate

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515237117·Converse Guard Chisel, 6mm wd, cvd rt 7 1/2"

MEDTRONIC EXTENDED INFUSION SET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·August 3, 2024

MEDTRONIC EXTENDED INFUSION SET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·August 3, 2024

ATG/SM-OSA APPLIANCES

FDA 510(k)
FDA Class 2 ·Dental

Micromate™ Navi+

FDA 510(k)
FDA Class 2 ·Radiology

MATRIX DETACHABLE COILS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - CORK·Product code HCG·December 16, 2010

TI COLLAR FOR 6MM DUAL-OPENINGIMPLANTS

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code NKB·January 25, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 11, 2014

UNKNOWN

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·June 9, 2021

ZIMMON PANCREATIC STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·October 16, 2020

EndoVive 3s Low Profile Balloon Kits Part Number: M00548900 (XMD P/N 70-0050-920) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

FDA Enforcement
Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016