20 results
·
28ms
·
Sources: EU EUDAMED, US FDA
VIVOSONIC NEUROSCREEN
FDA 510(k)
FDA Class 2
·Neurology
Berman Airways
FDA UDI
MERCURY ENTERPRISES, INC.·10641043800607·
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933189·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933790·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955934407·Percutaneous Transluminal Angioplasty Balloon C...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0100600·Caddie, Modular Bone Screws
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631106·
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631090·
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RITA STARBURST XLI ELECTROSURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
SPECIAL FOOT PUMP ASSEMBLY
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 28, 2018
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 6, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 18, 2012
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 18, 2012
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014