FDA 510(k) Applications Submitted by Jason Ma
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K202456 |
08/27/2020 |
M5 Recorder |
Global Instrumentation LLC |
| K162463 |
09/02/2016 |
Matrix Data Management System |
GLOBAL INSTRUMENTATION, LLC |
| K202281 |
08/12/2020 |
EDS Bioceramic Sealer (Bioseal) |
Essential Dental Systems |
| K223340 |
11/01/2022 |
EDS Calculus Softener TURBO CR |
Essential Dental Systems Inc. |
| K171054 |
04/10/2017 |
Biomet Knee Joint Replacement Prostheses |
Biomet, Inc |
| K131129 |
04/22/2013 |
CAS PSI SHOULDER |
ZIMMER CAS |
| K173057 |
09/28/2017 |
Zimmer Knee Joint Replacement Prostheses MR Labeling |
Zimmer, Inc. |
| K142933 |
10/09/2014 |
Biomet Tibial trays |
BIOMET, INC. |
| K143192 |
11/06/2014 |
Vanguard 360 Revision Knee System |
Biomet, Inc. |
| K183136 |
11/13/2018 |
Zimmer Segmental System Proximal Femoral Component |
Zimmer, Inc. |
| K103404 |
11/19/2010 |
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM |
ZIMMER GMBH |
| K133940 |
12/23/2013 |
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) |
BIOMET UK LTD. |
| K243580 |
11/19/2024 |
GraftGun Universal Graft Delivery System (GDS) |
SurGenTec, LLC. |
| K110604 |
03/03/2011 |
VBB SYSTEM |
SYNTHES |
| K090605 |
03/06/2009 |
CLAMPFIX |
SYNTHES (USA) |
| K100952 |
04/06/2010 |
MODIFICATION TO SYNTHES MATRIX SYSTEM |
SYNTHES SPINE |
| K082572 |
09/05/2008 |
USS ILIOSACRAL, USS POLYAXIAL |
SYNTHES SPINE |
| K082914 |
09/30/2008 |
CLAMPFIX |
SYNTHES SPINE |
| K170110 |
01/12/2017 |
Diana Medication Transfer Set |
ICU MEDICAL INC |
| K190157 |
01/30/2019 |
Diana ChemoClave Transfer Set |
ICU Medical |
| K160618 |
03/03/2016 |
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T |
GE MEDICAL SYSTEMS, LLC |
| K221121 |
04/18/2022 |
Volumat Polyethylene I.V. Administration Set |
Fresenius Kabi |
| K162403 |
08/29/2016 |
HyperBand |
GE Medical Systems, LLC |
| K112798 |
09/27/2011 |
LOCKING COMPRESSION PLATE SYSTEM |
SHANGHAI MICROPORT ORTHOPEDICS CO., LTD |
| K090078 |
01/12/2009 |
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT |
IOP, INC. |
| K010852 |
03/21/2001 |
OSMED TISSUE EXPANDER |
IOP, INC. |
| K972143 |
06/06/1997 |
MOA BONE / M-SPHERE |
IOP, INC. |
| K062252 |
08/03/2006 |
MOLTENO3 |
IOP, INC. |
| K003646 |
11/27/2000 |
SUTUREGROOVE WEIGHT SIZING SET |
IOP, INC. |
| K994289 |
12/21/1999 |
SUTUREGROOVE |
IOP, INC. |
| K053622 |
12/28/2005 |
SURGISIS OCULAR GRAFT |
IOP, INC. |
| K061058 |
04/17/2006 |
NEOZOLINE VENTILATION TUBES |
ADEPT MEDICAL LTD |
|
|
