FDA 510(k) Applications Submitted by GARY S MOCNIK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200207 |
01/28/2020 |
xPORT S Lens Fragmentation System |
Carl Zeiss Meditec Cataract Technology Inc. |
| K010353 |
02/06/2001 |
MED-LOGICS DISPOSABLE ALK TUBING |
MED-LOGICS, INC. |
| K080565 |
02/29/2008 |
MODIFICATION TO: SAVI APPLICATOR KIT |
CIANNA MEDICAL, INC. |
| K200584 |
03/06/2020 |
xPORT 304 (miCOR) System Lens Fragmentation System |
Carl Zeiss Meditec Cataract Technology Inc |
| K990748 |
03/08/1999 |
EDGE SYSTEMS STERILE TUBING |
EDGE SYSTEMS CORP. |
| K120804 |
03/16/2012 |
CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM |
CIANNA MEDICAL |
| K010872 |
03/23/2001 |
ML BLADE, MODEL ML7030 |
MED-LOGICS, INC. |
| K181007 |
04/17/2018 |
Cianna Medical SAVI Scout Reflector and SAVI Scout System |
Cianna Medical, Inc. |
| K191024 |
04/18/2019 |
xPORT Lens Fragmentation System |
Carl Zeiss Meditec Cataract Technology Inc. |
| K991577 |
05/06/1999 |
NIC TONE ACRYLIC RESINS |
MANUFACTURERA DENTAL CONTINENTAL |
| K101411 |
05/19/2010 |
SAVI PREPARATION DEVICE |
CIANNA MEDICAL, INC. |
| K121522 |
05/23/2012 |
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) |
POLYREMEDY, INC. |
| K161507 |
06/01/2016 |
Cianna Medical SAVI Scout Reflector and SAVI Scout System |
CIANNA MEDICAL, INC. |
| K171767 |
06/14/2017 |
Cianna Medical SAVI Scout Reflector and SAVI Scout System |
Cianna Medical, Inc. |
| K081677 |
06/17/2008 |
SAVI APPLICATOR KIT |
CIANNA MEDICAL, INC. |
| K002279 |
07/26/2000 |
ML EYE SPEAR, MODEL ML 27 ES |
MED-LOGICS, INC. |
| K222236 |
07/26/2022 |
miCOR System Lens Fragmentation System |
Carl Zeiss Meditec Cataract Technology Inc. |
| K112205 |
08/01/2011 |
SNORERX 9.0 |
CONSUMER HEALTH PRODUCTS, INC |
| K092351 |
08/04/2009 |
POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS |
POLYREMEDY, INC. |
| K092348 |
08/04/2009 |
POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS |
POLYREMEDY, INC. |
| K132463 |
08/07/2013 |
CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM |
CIANNA MEDICAL, INC. |
| K002515 |
08/15/2000 |
MEDLOGICS ML 4000, MODEL 4000 |
MED-LOGICS, INC. |
| DEN230055 |
08/25/2023 |
FSYXÖ Ocular Pressure Adjusting Pump (FSYXÖ OPAP) System |
Balance Ophthalmics, Inc. |
| K072399 |
08/27/2007 |
DEL SOL RED LIGHT THERAPY SYSTEM |
EDGE SYSTEMS, INC. |
| K192663 |
09/25/2019 |
Joimax Intracs System |
joimax GmbH |
| K192680 |
09/26/2019 |
Percusys« Plus Pedicle Screw System |
Joimax GmbH |
| K243014 |
09/27/2024 |
EyeQ nanoECP |
EyeQ Inc. |
| K072767 |
09/28/2007 |
QUASAR BLUE LIGHT THERAPY SYSTEM |
SILVER BAY, LLC |
| K203014 |
10/01/2020 |
EndoLIF Delta-Cage and DoubleWedge-Cage |
joimax GmbH |
| K993591 |
10/22/1999 |
BLADEWORKS DISPOSABLE ALK TUBING |
BLADE WORKS, INC. |
| K103215 |
11/01/2010 |
CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT |
CIANNA MEDICAL |
| K113569 |
12/02/2011 |
APNEARX |
APNEA SCIENCE CORPORATION |
| K073503 |
12/13/2007 |
VERSA LITE |
DIOMEDICS, INC. |
| K053475 |
12/14/2005 |
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 |
REFRACTEC, INC. |
| K214028 |
12/22/2021 |
MICOR Lens Fragmentation System |
Carl Zeiss Meditec Cataract Technology Inc. |
| K004040 |
12/29/2000 |
REDTECH GIPC 2000 |
RED-TECH, INC. |
| K193664 |
12/31/2019 |
SubQKath Catheter and Needle Set |
HK Surgical |
| K980085 |
01/09/1998 |
PHACO COMMANDER |
SCIERAN TECHNOLOGIES, INC. |
| K061470 |
05/26/2006 |
DEL SOL BLUE LIGHT THERAPY SYSTEM |
EDGE SYSTEMS CORPORATION |
| K011785 |
06/08/2001 |
NOVEL PRINT CYAN ALGINATES |
MANUFACTURERA DENTAL CONTINENTAL |
| K993225 |
09/27/1999 |
BLADEWORKS MICROKERATOME BLADE |
BLADE WORKS, INC. |
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