Panels › General, Plastic Surgery › Product code FYD · Class 2
Apparatus, Exhaust, Surgical
Regulation 878.5070
0510(k)s in 12 months (75 all time)
3recalls in 12 months (23 all time)
21recalls that name a 510(k)
Top companies in FYD
| Company | 510(k)s | Recalls |
|---|---|---|
| Buffalo Filter Co., Inc. | 21 | 0 |
| Microtek Medical Inc | 0 | 10 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 8 |
| I.C Medical, Inc. | 5 | 0 |
| SurgiSmoke Solutions | 0 | 3 |
| Conmed Corporation | 2 | 0 |
| Megadyne Medical Products, Inc. | 2 | 0 |
| Quinn Healthcare Products | 2 | 0 |
| Stackhouse Assoc. | 2 | 0 |
| Acuderm, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 2024 | K240127 | PlumeSafe X5 Smoke Management System Conmed Corporation | FYD |
| Apr 10, 2024 | K233789 | 8Q10 Surclear Smoke Plume Evacuation System Surnic Corporation | FYD |
| Jan 3, 2022 | K213068 | Medline Smoke Evacuation Shroud Medline Industries, Inc. | FYD |
| Mar 25, 2021 | K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System Northgate Technologies, Inc. | FYD |
| Jun 26, 2020 | K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Senso Megadyne Medical Products, Inc. | FYD |
| Aug 29, 2019 | K192035 | EvaQMax Smoke Evacuation System Bio Protech, Inc., KR | FYD |
| Jul 26, 2019 | K191328 | Megadyne Foot Switch Megadyne Medical Products, Inc. | FYD |
| Feb 7, 2019 | K182224 | SafeAir Smoke Evacuator compact Lina Medical Aps, PL | FYD |
| May 18, 2018 | K173108 | Smoklean Sejong Medical Co., Ltd., KR | FYD |
| Oct 30, 2017 | K163659 | Crystal Vision I.C Medical, Inc. | FYD |
| Jan 14, 2015 | K142335 | RapidVac Smoke Evacuator System Covidien | FYD |
| Mar 3, 2014 | K131402 | VISICLEAR SMOKE EVACUATION SYSTEM Buffalo Filter Co., Inc. | FYD |
| May 5, 2009 | K091139 | CONMED AER DEFENSE SMOKE EVACUATOR Conmed Corporation | FYD |
| Jun 6, 2006 | K053464 | SERVICE MANAGER SM40SE Conmed Integrated Systems, Canada, Ulc | FYD |
| Feb 13, 2006 | K052797 | LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM Medtek Devices, Inc. | FYD |
| Oct 4, 2005 | K043494 | MASTEL LASER CLEAN ROOM, MODEL EBS-100 Mastel Precision Surgical Instruments, Inc. | FYD |
| May 7, 2004 | K032400 | LAFACI Vision Pro, LLC | FYD |
| May 3, 2002 | K020510 | SMOKE EVACUATION HOSES/TUBING Dm Medical, Inc. | FYD |
| Nov 29, 2001 | K012991 | NEPTUNE WASTE MANAGEMENT STSTEM Stryker Instruments | FYD |
| Feb 1, 2001 | K003840 | CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES I.C Medical, Inc. | FYD |
| Jun 15, 2000 | K001082 | STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 Stackhouse, Inc. | FYD |
| Jun 8, 2000 | K000904 | PENADAPT 10 Buffalo Filter Co., Inc. | FYD |
| Aug 24, 1999 | K990037 | NEPTUNE WASTE MANAGEMENT SYSTEM American Immuno Tech | FYD |
| Aug 20, 1999 | K992361 | PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 Pall Medical | FYD |
| Aug 16, 1999 | K983298 | BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF Buffalo Filter Co., Inc. | FYD |
| Aug 11, 1999 | K983364 | BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 Buffalo Filter Co., Inc. | FYD |
| Aug 11, 1999 | K983333 | BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 Buffalo Filter Co., Inc. | FYD |
| Jun 3, 1999 | K991167 | STERIS SMOKE EVACUATION SYSTEM STERIS Corporation | FYD |
| Jun 29, 1998 | K980915 | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM Valleylab, Inc. | FYD |
| Dec 19, 1997 | K973610 | SKYVAL Pyramid Air Systems | FYD |
| Nov 4, 1997 | K970352 | SMARTVAC SMOKE EVACUATION SYSTEM Isomedix Operations, Inc. | FYD |
| Aug 28, 1995 | K952981 | FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC Utah Medical Products, Inc. | FYD |
| Jul 10, 1995 | K943226 | BUFFALO FILTER REPLACEMENT FILTER #BSPF030 Buffalo Filter Co., Inc. | FYD |
| Jul 7, 1995 | K943227 | BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 Buffalo Filter Co., Inc. | FYD |
| Mar 24, 1994 | K940266 | BEI MEDICAL SYSTEMS' SMOKE EVACUATOR Bei Medical Systems Co., Inc. | FYD |
| Mar 7, 1994 | K935439 | SNJ SMOKE EVACUATION SUCTION WAND Lca, Inc. | FYD |
| Feb 18, 1994 | K932230 | CRYSTAL VISION AND ACCESSORIES I.C Medical, Inc. | FYD |
| Feb 9, 1994 | K930043 | ACU-EVAC Acuderm, Inc. | FYD |
| Nov 30, 1993 | K930167 | REUSABLE TOWEL AND GOWN PACKS Custom Sterile Services, Inc. | FYD |
| Nov 30, 1993 | K930062 | BUFFALO FILTER REPLACEMENT FILTER #BST300UL Buffalo Filter Co., Inc. | FYD |
| Nov 30, 1993 | K930058 | BUFFALO FILTER REPLACEMENT FILTER #BPTU100 Buffalo Filter Co., Inc. | FYD |
| Nov 16, 1993 | K930434 | PLUMEMASTER SMOKE EVACUATION SYSTEM Sorenson Laboratories, Inc. | FYD |
| Nov 12, 1993 | K930066 | BUFFALO FILTER REPLACEMENT FILTER #BCCHAR Buffalo Filter Co., Inc. | FYD |
| Nov 12, 1993 | K930065 | BUFFALO FILTER REPLACEMENT FILTER #BCR0043 Buffalo Filter Co., Inc. | FYD |
| Nov 12, 1993 | K930064 | BUFFALO FILTER REPLACEMENT FILTER #BCR0030 Buffalo Filter Co., Inc. | FYD |
| Nov 12, 1993 | K930063 | BUFFALO FILTER REPLACEMENT FILTER #BCULPA Buffalo Filter Co., Inc. | FYD |
| Nov 12, 1993 | K930060 | BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO Buffalo Filter Co., Inc. | FYD |
| Nov 3, 1993 | K930041 | VICROSAFE 6 AND VICROSAFE 12 Buffalo Filter Co., Inc. | FYD |
| Nov 2, 1993 | K930061 | BUFFALO FILTER REPLACEMENT FILTER BST312PF Buffalo Filter Co., Inc. | FYD |
| Nov 2, 1993 | K930040 | BUFFALO FILTER REPLACEMENT #BLFS-101/103 Buffalo Filter Co., Inc. | FYD |
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