FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K971107 |
ALEXANDER MFG. CO. |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 |
06/05/1997 |
K201203 |
Anest Iwata Sparmax Co., Ltd. |
Cliq Aspirator |
09/03/2020 |
K122619 |
APPLIED MEDICAL |
EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET |
10/02/2012 |
K011601 |
ARDO MEDICAL AG |
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX |
06/08/2001 |
K223373 |
Aroa Biosurgery Ltd. |
EnivoÖ |
04/07/2023 |
K153459 |
ATHENA GTX |
TACVAC |
01/28/2016 |
K090445 |
ATMOS INC. |
ATMOS C361/C451 SUCTION PUMP |
02/27/2009 |
K103042 |
ATMOS INC. |
ATMOS E 201 THORAX AND ATMOS S 201 THORAX |
04/15/2011 |
K130131 |
ATRIUM MEDICAL CORP. |
EDRAIN CHEST DRAINAGE SYSTEM |
02/28/2013 |
K090379 |
AVITA CORPORATION |
AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES |
05/26/2010 |
K980392 |
BYRON MEDICAL |
PSI-TEC ASPIRATOR |
03/05/1998 |
K181667 |
Centese, Inc. |
Thoraguard System |
11/29/2018 |
K161002 |
COOK INCORPORATED |
Aprima Smartesis Centesis Pump |
09/28/2016 |
K221676 |
DRW Medical |
Exsalta |
09/16/2022 |
K013116 |
EVER-SAFETY TECHNICAL SERVICE |
DURQ/ QUALIDURA |
01/18/2002 |
K080745 |
GENADYNE BIOTECHNOLOGIES, INC. |
GENADYNE A4 POWERED SUCTION PUMP |
07/30/2008 |
K220126 |
Geon Corporation |
Geonic Nasal Aspirator, Geonic Nasal Cleaner |
02/02/2023 |
K970186 |
GI SUPPLY |
GI SUPPLY PARACENTESIS PUMP |
02/14/1997 |
K221042 |
GI Supply, Inc. |
Renova RP Centesis Pump |
04/19/2023 |
K052626 |
HAEMONETICS CORP. |
SMARTSUCTION HARMONY DEVICE |
10/05/2005 |
K062801 |
HAEMONETICS CORP. |
SMARTSUCTION SOLO DEVICE |
10/04/2006 |
K093241 |
HERSILL, S.L. |
V7 PORTABLE SUCTION UNITS |
04/27/2010 |
K960492 |
I.C. MEDICAL, INC. |
SI CONTROLLER MODEL SI 500 |
12/23/1996 |
K041405 |
INDUSTRIAL & MEDICAL DESIGN, INC. |
ASPIRATION PUMP, MODEL IMD-020 |
09/02/2004 |
K981703 |
KARL STORZ ENDOSCOPY |
KSEA UNIMAT 45 |
08/12/1998 |
K993668 |
LAERDAL MEDICAL A/S |
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 |
12/20/1999 |
K980454 |
LYSONIX, INC. |
LYSONIX ASPIRATION PUMP |
03/18/1998 |
K092903 |
MAQUET GMBH AND CO. KG |
BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING |
12/01/2009 |
K982371 |
MEDCO MFG. |
MEDCO ASPIRATOR IV |
02/12/1999 |
K130123 |
MEDELA AG |
BASIC AND DOMINANT FLEX SUCTION PUMPS |
10/11/2013 |
K021368 |
MEDELA AG |
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 |
05/15/2002 |
K033179 |
MEDELA AG |
MEDELA CLARIO HOME CARE PUMP |
10/15/2003 |
K043544 |
MEDELA AG |
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR |
01/07/2005 |
K130210 |
MEDELA AG |
MEDELA THOPAZ |
03/15/2013 |
K080212 |
MEDELA AG |
MEDELA THOPAZ, MODEL 200 0288 |
07/23/2008 |
K141553 |
MEDELA AG |
MEDELA THOPAZ+ |
08/25/2014 |
K061205 |
MEDELA AG |
MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR |
06/21/2006 |
K153663 |
MEDELA AG |
Vario 8/18/ci |
05/18/2016 |
K983552 |
MEDELA, INC. |
BASIC, MEDIAN, DOMINANT, AND VARIO |
01/07/1999 |
K963775 |
MEDICAL SPECIFICS, INC. |
MODEL 8800 ASPIRATOR |
03/26/1997 |
K203135 |
Medline Industries, Inc. |
Medline Vacu-line Suction Aspirator |
05/04/2021 |
K052650 |
MERITS HEALTH PRODUCTS CO., LTD. |
PIONEER U601 SERIES ASPIRATOR |
11/04/2005 |
K973268 |
MICROAIRE SURGICAL INSTRUMENTS, INC. |
MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM |
11/26/1997 |
K040239 |
NEOMEDIX CORP. |
SUPRAFLOW CONSOLE |
02/17/2004 |
K042943 |
NOUVAG AG |
NOUVAG AG - VACUSON 40 AND VACUSON 60 |
12/17/2004 |
K061133 |
NOVASPINE LLC |
SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S |
07/11/2006 |
K062610 |
OHIO MEDICAL CORPORATION |
CARE-E-VAC 3 |
09/28/2006 |
K081185 |
OHIO MEDICAL CORPORATION |
MOBLVAC W.C. |
05/02/2008 |
K051758 |
PENUMBRA, INC. |
PENUMBRA ASPIRATION PUMP, MODEL 115V |
08/17/2005 |
K140179 |
PRECISION MEDICAL, INC. |
EASY GO VAC |
04/25/2014 |
K971749 |
PRECISION MEDICAL, INC. |
EASYGO ASPIRATOR |
04/01/1998 |
K173389 |
Rex Medical, L.P. |
Rex Medical Aspiration Pump |
01/30/2018 |
K980301 |
SERVIZI MEDICO ESTETICI ITALINAI SRL. |
IP-16 |
03/24/1998 |
K013585 |
SERVOX MEDIZINTECHNIK GMBH |
MEDIPORT 2000 MOBILE |
01/28/2002 |
K222547 |
Shenzhen XinLianFeng Technology CO.,LTD |
Electric nasal aspirator |
10/20/2022 |
K141255 |
SIMEX MEDIZINTECHNIK GMBH |
SIMEX SUBGLOTTIC ASPIRATION SYSTEM |
09/22/2014 |
K222856 |
SOMAVAC Medical Solutions, Inc. |
SOMAVAC 100 Sustained Vacuum System |
10/19/2022 |
K180606 |
SOMAVAC Medical Solutions, Inc. |
SOMAVAC Device |
05/31/2018 |
K231063 |
SOMAVAC Medical Solutions, Inc. |
SOMAVAC« 100 Sustained Vacuum System |
05/12/2023 |
K992026 |
SORING GMBH MEDIZINTECHNIK |
SORING GMBH, SONOCA 300 |
09/23/1999 |
K964997 |
SSCOR |
S-SCORT (2500) |
03/05/1997 |
K041154 |
SSCOR |
S-SCORT...JR QUICKDRAW, MODEL 2400 |
05/18/2004 |
K981602 |
SUNRISE MEDICAL HHG, INC. |
DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR |
07/17/1998 |
K180863 |
TaiDoc Technology Corporation |
FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator |
12/19/2018 |
K965059 |
THOMAS INDUSTRIES |
CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) |
03/04/1997 |
K041199 |
THOMAS INDUSTRIES |
MEDI-PUMP ASPIRATOR, MODEL 1615 |
06/01/2004 |
K984363 |
XOMED, INC. |
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM |
02/26/1999 |
K071607 |
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. |
ASA01 HEAVY DUTY SUCTION PUMP |
06/26/2007 |
K170533 |
ZOLL Medical Corporation |
Model 330 Multifunction Aspirator |
04/18/2017 |