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