14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SAFE-T-TUBE RADIOPAQUE
FDA 510(k)
FDA Class 2
·Anesthesiology
TLX
FDA UDI
Nuvasive, Inc.·00887517987013·TLX20 Inserter, Low Profile
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376309163·Cross Connector, Head to Head, 50mm
PLIF Allograft
FDA UDI
Seaspine Orthopedics Corporation·10889981087746·Bone Inserter
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515237216·Neivert Osteo, 4mm single guarded, 8"
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938078·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939242·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955936906·Percutaneous Transluminal Angioplasty Balloon C...
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TCM MASSAGER
FDA 510(k)
FDA Class 2
·Neurology
14F X 28CM SPLIT CATH III
FDA Adverse Event
Malfunction
·MEDCOMP·Product code MSD·November 18, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 25, 2013
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·July 11, 2014
EndoVive 3s Low Profile Balloon Kits Part Number: M00549440 (XMD P/N 70-0050-E22) 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