9 results
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19ms
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Sources: EU EUDAMED, US FDA
AYNELISA M2-ANTIBODIES
FDA 510(k)
FDA Class 2
·Immunology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515237179·Cook Osteotome, 5mm cut edge, 6 1/4", straight ...
Grasping forceps
FDA UDI
SOPRO-COMEG GmbH·04059082023007·
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
PERSONA NATURAL TIBIA BASEPLATES
FDA 510(k)
FDA Class 2
·Orthopedic
LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 25, 2013
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·December 16, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 11, 2014
EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) 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