13 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PULSE
FDA UDI
Nuvasive, Inc.·00195377153968·PULSE Extension Arm, Short
Clear Anatomical Face Mask
FDA UDI
MERCURY ENTERPRISES, INC.·10641043505038·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105030·Implant Inserter, 8-10mm, Sleeveless
AMIGO WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDART 520 COOLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
9MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·March 15, 2018
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 10, 2013
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 5, 2011
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
FDA Enforcement
Class II
·Terminated·TriMed Inc.·June 27, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Baxter Interlink System Minivolume Extension Set; catalog 1C8412; Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code FPA·October 17, 2002