FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K990037 |
AMERICAN IMMUNO TECH |
NEPTUNE WASTE MANAGEMENT SYSTEM |
08/24/1999 |
K192035 |
Bio Protech, Inc. |
EvaQMax Smoke Evacuation System |
08/29/2019 |
K983364 |
BUFFALO FILTER CO., INC. |
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 |
08/11/1999 |
K983298 |
BUFFALO FILTER CO., INC. |
BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF |
08/16/1999 |
K983333 |
BUFFALO FILTER CO., INC. |
BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 |
08/11/1999 |
K000904 |
BUFFALO FILTER CO., INC. |
PENADAPT 10 |
06/08/2000 |
K131402 |
BUFFALO FILTER CO., INC. |
VISICLEAR SMOKE EVACUATION SYSTEM |
03/03/2014 |
K091139 |
CONMED CORPORATION |
CONMED AER DEFENSE SMOKE EVACUATOR |
05/05/2009 |
K053464 |
CONMED INTEGRATED SYSTEMS, CANADA, ULC |
SERVICE MANAGER SM40SE |
06/06/2006 |
K142335 |
COVIDIEN |
RapidVac Smoke Evacuator System |
01/14/2015 |
K020510 |
DM MEDICAL INC. |
SMOKE EVACUATION HOSES/TUBING |
05/03/2002 |
K163659 |
I.C MEDICAL, INC. |
Crystal Vision |
10/30/2017 |
K003840 |
I.C. MEDICAL, INC. |
CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES |
02/01/2001 |
K970352 |
ISOMEDIX OPERATIONS INC. |
SMARTVAC SMOKE EVACUATION SYSTEM |
11/04/1997 |
K182224 |
LiNA Medical APS |
SafeAir Smoke Evacuator compact |
02/07/2019 |
K043494 |
MASTEL PRECISION SURGICAL INSTRUMENTS, INC. |
MASTEL LASER CLEAN ROOM, MODEL EBS-100 |
10/04/2005 |
K213068 |
Medline Industries, Inc. |
Medline Smoke Evacuation Shroud |
01/03/2022 |
K052797 |
MEDTEK DEVICES, INC. |
LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM |
02/13/2006 |
K191328 |
Megadyne Medical Products, Inc. |
Megadyne Foot Switch |
07/26/2019 |
K200250 |
Megadyne Medical Products, Inc. |
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor |
06/26/2020 |
K202944 |
Northgate Technologies Inc. |
NEBULAE SRS Laparoscopic Surgical Smoke Removal System |
03/25/2021 |
K992361 |
PALL MEDICAL |
PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 |
08/20/1999 |
K973610 |
PYRAMID AIR SYSTEMS |
SKYVAL |
12/19/1997 |
K173108 |
Sejong Medical Co., Ltd. |
Smoklean |
05/18/2018 |
K001082 |
STACKHOUSE, INC. |
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 |
06/15/2000 |
K991167 |
STERIS Corporation |
STERIS SMOKE EVACUATION SYSTEM |
06/03/1999 |
K012991 |
STRYKER INSTRUMENTS |
NEPTUNE WASTE MANAGEMENT STSTEM |
11/29/2001 |
K980915 |
VALLEYLAB, INC. |
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM |
06/29/1998 |
K032400 |
VISION PRO, L.L.C. |
LAFACI |
05/07/2004 |