Medical Device Manufacturer · US , Goleta , CA

Hanson Medical, Inc.

14 submissions · 14 cleared · Since 1997
14
Total
14
Cleared
0
Denied

Hanson Medical, Inc. — FDA 510(k) Submissions

Hanson Medical, Inc. has submitted 14 FDA 510(k) premarket notifications since 1997, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Elastomer, Silicone Block, Prosthesis, Nose, Internal, Elastomer, Silicone, For Scar Management, System, Catheter Control, Steerable, Implant, Malar . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
SENSEI X ROBOTIC CATHETER SYSTEM
K141822 · DXX System, Catheter Control,... · Cardiovascular
Aug 2014 29d
HANSON MEDICAL FACIAL IMPLANTS
K090803 · FZE Prosthesis, Nose, Internal · General & Plastic Surgery
Jun 2010 463d
MONARCH NASAL IMPLANT
K071018 · FZE Prosthesis, Nose, Internal · General & Plastic Surgery
May 2007 45d
MONARCH NASAL IMPLANT
K041690 · FZE Prosthesis, Nose, Internal · General & Plastic Surgery
Feb 2005 234d
HANSON SCAR ADE
K040307 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Aug 2004 185d
HANSON MEDICAL CALF IMPLANT
K030808 · MIB Elastomer, Silicone Block · General & Plastic Surgery
Apr 2003 39d
HANSON MEDICAL GLUTEAL IMPLANT
K030809 · MIB Elastomer, Silicone Block · General & Plastic Surgery
Apr 2003 39d
POWERFLEX PEC IMPLANT
K973729 · MIC Implant, Muscle, Pectoralis · General & Plastic Surgery
Dec 1997 85d
DURASIL I AND DURASIL II
K973730 · MIB Elastomer, Silicone Block · General & Plastic Surgery
Dec 1997 85d
DURALASTIC ANATOMICAL NASAL IMPLANTS
K973573 · FZE Prosthesis, Nose, Internal · General & Plastic Surgery
Nov 1997 55d
SILICONE CARVING BLOCK
K973728 · MIB Elastomer, Silicone Block · General & Plastic Surgery
Nov 1997 44d
DURALASTIC ANATOMICAL CHIN IMPLANTS
K973575 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Nov 1997 49d
DURALASTIC ANATOMICAL MALAR IMPLANT
K973574 · LZK Implant, Malar · General & Plastic Surgery
Oct 1997 35d
KELOCOTE SCAR GEL AND KELOCOTE LASER GEL
K973572 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Oct 1997 32d
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