18 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CONTINUM V
FDA 510(k)
FDA Class 2
·Dental
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175405·Z-Rod, Dia. 5.5mm, Co-Cr, 180mm
Gorilla Plating System
FDA UDI
Paragon 28, Inc.·00889795009623·BOW & Arrow Cotton Plate, 8mm Wedge
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933493·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955934100·Percutaneous Transluminal Angioplasty Balloon C...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197524865·Weil-Blakesley Rongeur
fenest...
Toilet Support Arms
FDA UDI
Ropox A/S·05707581002502·
RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL
FDA 510(k)
FDA Class 2
·Neurology
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HANAROSTENT® Benefit™ Biliary (NNN)
FDA UDI
M.I.Tech Co., Ltd.·08806367092922·Un-covered self-expanding nitinol biliary stent
HANAROSTENT® Benefit™ Biliary (NNN)
FDA UDI
M.I.Tech Co., Ltd.·08806367092748·Un-covered self-expanding nitinol biliary stent
HANAROSTENT® Biliary (NNN)
FDA UDI
M.I.Tech Co., Ltd.·08806367047038·Un-covered self-expanding nitinol biliary stent
HANAROSTENT® Biliary (NNN)
FDA UDI
M.I.Tech Co., Ltd.·08806367017567·Un-covered self-expanding nitinol biliary stent
PINNACLE MTL INS NEUT40IDX60OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·April 8, 2013
LIBERTE MONORAIL CORONARY STENT DELIVERYS YSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MAF·May 8, 2008
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 5, 2011
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024