11 results
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19ms
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Sources: EU EUDAMED, US FDA
KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLIF Allograft
FDA UDI
Seaspine Orthopedics Corporation·10889981087739·Knob, Modular PLIF Allograft Inserter
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
FDA 510(k)
FDA Class 2
·Orthopedic
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9
FDA 510(k)
FDA Class 2
·General Hospital
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 25, 2013
OASIS DRY SUCTION WATER SEAL CHEST DRAIN
FDA Adverse Event
ATRIUM MEDICAL CORPORATION·Product code KDQ·December 7, 2010
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 11, 2014
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 5, 2015
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 9, 2015
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 30, 2018
EndoVive 3s Low Profile Balloon Kits Part Number: M00549430 (XMD P/N 70-0050-D22) 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