K170864 |
03/23/2017 |
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit |
Maine Standards Company LLC |
K162705 |
09/28/2016 |
VALIDATE« D-Dimer Calibration Verification/ Linearity Test Kit |
MAINE STANDARDS COMPANY LLC |
K152961 |
10/07/2015 |
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit |
MAINE STANDARDS COMPANY LLC |
K142964 |
10/14/2014 |
VALIDATE Anemia Calibration Verification/ Linearity Test Kit |
MAINE STANDARDS COMPANY, LLC |
K163498 |
12/13/2016 |
VALIDATE Heparin Calibration Verification/Linearity Test Kit |
MAINE STANDARDS COMPANY, LLC |
K980336 |
01/28/1998 |
IV STANDS |
CLINTON INDUSTRIES, INC. |
K070500 |
02/21/2007 |
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM |
NI MEDICAL |
K080941 |
04/03/2008 |
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM |
N.I. MEDICAL, LTD. |
K061628 |
06/12/2006 |
JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 |
MAQUET CARDIOPULMONARY AG |
K061832 |
06/29/2006 |
JOSTRA HLM TUBING SETS WITH SAFELINE COATING |
MAQUET CARDIOPULMONARY AG |
K220760 |
03/15/2022 |
Pre-Formed Penile Silicone Block |
International Medical Devices, Inc. |
K181387 |
05/25/2018 |
Pre-Formed Penile Silicone Block |
International Medical Devices, Inc. |
K042380 |
09/01/2004 |
SILICONE BLOCK |
NATIONAL MEDICAL DEVICES, INC. |
K162624 |
09/20/2016 |
Pre-Formed Penile Silicone Block |
INTERNATIONAL MEDICAL DEVICES, INC. |
K071104 |
04/19/2007 |
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM |
FLIER'S QUALITY WATER SYSTEMS INC |
K231261 |
05/01/2023 |
Altaviz Needle Kit II |
Altaviz, LLC |
K222681 |
09/06/2022 |
Altaviz Needle Kit |
Altaviz, LLC |
K230549 |
02/28/2023 |
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG |
Shenzhen Xiazhifeng Electronic Co., Ltd. |
K111206 |
04/29/2011 |
TECO DIAGNOSTICS SALIVA ALCOHOL TEST |
TECO DIAGNOSTICS |
K232571 |
08/24/2023 |
CATHTONGÖ II PICC Catheter |
L&Z US, Inc. |
K232594 |
08/25/2023 |
CATHTONGÖ II PICC Catheter |
L&Z US, Inc. |
K152642 |
09/15/2015 |
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode |
LCCS PRODUCTS LIMITED |
K230135 |
01/18/2023 |
Copioumed Chemotherapy Isolation Gown |
Copioumed International Inc. |
K964696 |
11/22/1996 |
SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS |
SUNSOFT CORP. |
K162755 |
09/30/2016 |
Picocare |
WON TECH CO., LTD. |
K972538 |
07/08/1997 |
FLOW-EZE BLUNT CANNULA (1999BC) |
ACACIA, INC. |
K120152 |
01/18/2012 |
CERASORB PLUS |
RIEMSER ARZNEIMITTEL AG |
K110520 |
02/23/2011 |
BIOLIS 12I |
TOKYO BOEKI MEDISYS INC. |
K960965 |
03/11/1996 |
FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 |
COEUR LABORATORIES, INC. |
K961189 |
03/26/1996 |
TAS A PTT TEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
K040958 |
04/13/2004 |
PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 |
TOKYO BOEKI MEDICAL SYSTEM LTD. |
K961814 |
05/10/1996 |
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
K971748 |
05/12/1997 |
TAS PT-NCTEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
K113042 |
10/12/2011 |
REVOIS IMPLANT SYSTEM |
RIEMSER ARZNEIMITTEL AG |
K113282 |
11/07/2011 |
CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO |
RIEMSER ARZEIMITTEL AG |
K103531 |
12/01/2010 |
PRESTIGE 24I; BIOLIS 24I; MGC 240 |
TOKYO BOEKI MEDISYS INC. |
K965214 |
12/30/1996 |
COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) |
COEUR LABORATORIES, INC. |
K161016 |
04/11/2016 |
Z-Clamp ISP System |
Zavation, LLC |
K173752 |
12/08/2017 |
SI Screw System |
Zavation Medical Products, LLC |
K112220 |
08/02/2011 |
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL |
DEVILBISS HEALTHCARE LLC |
K123127 |
10/04/2012 |
VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 |
MAINE STANDARDS CO. |
K133550 |
11/19/2013 |
VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT |
MAINE STANDARDS COMPANY LLC |