FDA 510(k) Applications Submitted by JOHN TO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K163578 |
12/20/2016 |
EasyTouch Safety Pen Needle |
MHC Medical Products, LLC. |
| K160987 |
04/08/2016 |
ReWalk(TM) |
REWALK ROBOTICS INC. |
| K130274 |
02/04/2013 |
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM |
ELITE SURGICAL SUPPLIES (PTY) LTD. |
| K030037 |
01/06/2003 |
UNIVERSAL TOTAL WRIST SYSTEM |
KINETIKOS MEDICAL, INC. |
| K023770 |
11/12/2002 |
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) |
KINETIKOS MEDICAL, INC. |
| K160076 |
01/14/2016 |
XCageÖ Interbody Fusion System |
Ouroboros Medical, Inc. |
| K133514 |
11/15/2013 |
XCAGE INTERBODY FUSION SYSTEM |
OUROBOROS MEDICAL |
| K991620 |
05/11/1999 |
VISINE FOR CONTACTS |
PFIZER, INC. |
| K102278 |
08/11/2010 |
QUADRA BLOC TENS PLUS |
GRADIENT TECHNOLOGIES, LLC |
| K062547 |
08/30/2006 |
QUADRA BLOC TENS, MODEL 101 |
GRADIENT TECHNOLOGIES, LLC |
| K961404 |
04/11/1996 |
MX960 REUSABLE PRESSURE TRANSDUCER |
MEDEX, INC. |
| K961527 |
04/22/1996 |
MX703 AND MX730 CONTINUOUS FLUSH DEVICES |
MEDEX, INC. |
| K954970 |
10/30/1995 |
STOPCOCK & LUER LOCK PLUG |
MEDEX, INC. |
| K192129 |
08/07/2019 |
ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens |
Clearlab SG Pte, Ltd |
| K970249 |
01/22/1997 |
SIMPLEX AIRBRATOR |
SIMPLEX MEDICAL SYSTEMS, INC. |
| K022906 |
09/03/2002 |
RESQPOD CIRCULATORY ENHANCER |
CPRX LLC |
| K040356 |
02/13/2004 |
KOMPRESSOR SCREW SYSTEM |
KINETIKOS MEDICAL, INC. |
| K061465 |
05/26/2006 |
KMI CEMENT RESTRICTOR IMPLANT |
KINETIKOS MEDICAL, INC. |
| K041461 |
06/02/2004 |
KMI DISTAL VOLAR RADIUS PLATE SYSTEM |
KINETIKOS MEDICAL, INC. |
| K051611 |
06/17/2005 |
MBARESORB IMPLANT |
KINETIKOS MEDICAL, INC. |
| K032806 |
09/09/2003 |
KATALYST RADIAL HEAD IMPLANT |
KINETIKOS MEDICAL, INC. |
| K024233 |
12/23/2002 |
KOMPRESSOR SCREW SYSTEM |
KINETIKOS MEDICAL, INC. |
| K061749 |
06/21/2006 |
ECLIPSE TOTAL ANKLE IMPLANT |
KINETIKOS MEDICAL, INC. |
| K971332 |
04/10/1997 |
AMS MAINSTAY UROLOGIC BONE ANCHOR |
AMERICAN MEDICAL SYSTEMS, INC. |
| K971512 |
04/28/1997 |
AMS COAGULOOP RESECTION ELECTRODE |
AMERICAN MEDICAL SYSTEMS, INC. |
| DEN130034 |
06/17/2013 |
REWALK |
ARGO MEDICAL TECHNOLOGIES, INC. |
| K971145 |
03/28/1997 |
GLUCOSITE TEST SYSTEM |
GDS TECHNOLOGY, LLC. |
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