| K072374 |
08/23/2007 |
COMPASS |
SCANDITRONIX WELLHOFER GMBH |
| K162459 |
09/02/2016 |
AccuPoint Electrode |
MICROPROBES FOR LIFE SCIENCE, INC. DBA NEURON |
| K944497 |
09/13/1994 |
UNILECT, MONITAB AND BIOTRACE-HR |
MSB LTD. |
| K944496 |
09/13/1994 |
BIOTRACE-N, NS, 410 AND RT |
MSB LTD. |
| K170835 |
03/20/2017 |
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE |
Hightech Development |
| K190406 |
02/21/2019 |
SDS2.2 dental implant |
SDS Swiss Dental Solutions AG |
| K181953 |
07/23/2018 |
SDS1.2 dental implant |
SDS Swiss Dental Solutions AG |
| K954769 |
10/16/1995 |
BIEGLER BW385L BLOOD & INFUSION WARMER |
BIEGLER MEDICAL PRODUCTS, INC. |
| K133360 |
11/01/2013 |
AERONEB SOLO; AERONEB SOLO ADAPTER |
AEROGEN LTD |
| K143719 |
12/29/2014 |
Aeroneb USB Contoller System |
Aerogen Limited |
| K100244 |
01/27/2010 |
METRO SOFT |
METRO OPTICS OF AUSTIN, INC. |
| K030167 |
01/16/2003 |
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER |
CLEARLAB PTE LTD. |
| K010223 |
01/24/2001 |
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) |
AMERICAN CONTACT LENS, INC. |
| K100221 |
01/26/2010 |
INTELLIWAVE3 |
ART OPTICAL CONTACT LENS, INC. |
| K990264 |
01/27/1999 |
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS |
METRO OPTICS OF AUSTIN, INC. |
| K010256 |
01/29/2001 |
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL |
OPTI-CENTRE LABORATORIES |
| K100443 |
02/17/2010 |
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL |
X-CEL CONTACTS, INC. |
| K100456 |
02/17/2010 |
CVUE ADVANCED DEFINITIVE |
UNILENS CORP., USA |
| K030593 |
02/25/2003 |
FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC |
X-CEL CONTACTS, A WALMAN CO. |
| K080512 |
02/25/2008 |
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT |
METRO OPTICS OF AUSTIN, INC. |
| K080632 |
03/05/2008 |
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS |
CLEARLAB SG PTE LTD. |
| K070628 |
03/07/2007 |
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. |
CONTAMAC LTD. |
| K990757 |
03/08/1999 |
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA |
CANTOR & SILVER LTD. |
| K030748 |
03/10/2003 |
AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER |
CLEARLAB PTE LTD. |
| K990815 |
03/11/1999 |
COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS |
COLORSOFT LABORATORIES CORP. |
| K070767 |
03/20/2007 |
EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION |
LAPIS LAZULI INTERNATIONAL NV |
| K991015 |
03/26/1999 |
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) |
LAMDA POLYTECH LTD. |
| K981252 |
04/06/1998 |
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) |
ALDEN OPTICAL LABS., INC. |
| K040914 |
04/08/2004 |
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS |
EXERO PRODUCTS, INC. |
| K001227 |
04/17/2000 |
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT |
OPTI-CENTRE LABORATORIES |
| K011234 |
04/23/2001 |
BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L |
AMERICAN BIOCURVE, INC. |
| K971515 |
04/25/1997 |
PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK) |
BIOMED DEVICES CORP. |
| K081178 |
04/25/2008 |
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES |
CONTAMAC LTD. |
| K011316 |
04/30/2001 |
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T |
AMERICAN CONTACT LENS, INC. |
| K071203 |
05/01/2007 |
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES |
OPTIKEM INTERNATIONAL, INC. |
| K051104 |
05/02/2005 |
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION |
LAPIS LAZULI, NV |
| K121324 |
05/02/2012 |
AVT NATURASOFT |
ADVANCED VISION TECHNOLOGIES |
| K981779 |
05/20/1998 |
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT |
CANTOR & SILVER LTD. |
| K001585 |
05/22/2000 |
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE |
AMERICAN BIOCURVE, INC. |
| K001584 |
05/22/2000 |
METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT |
MED VICE CONSULTING, INC. |
| K121519 |
05/22/2012 |
ISIGHT |
C & E GP SPECIALISTS, INC. |
| K962121 |
05/31/1996 |
HORIZON/WESTHIN 55-G |
WESTCON CONTACT LENS CO., INC. |
| K051477 |
06/03/2005 |
MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) |
MI GWANG CONTACT LENS CO., LTD. |
| K991995 |
06/14/1999 |
SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS |
SOFTCHROME, INC. |
| K992054 |
06/17/1999 |
ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS |
ADVENTURES IN COLOR TECHNOLOGY, LTD. |
| K041700 |
06/22/2004 |
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR |
CANTOR & NISSEL LTD. |
| K001962 |
06/27/2000 |
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- |
BESCON CO., LTD. |
| K012132 |
07/09/2001 |
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS |
CANTOR & NISSEL LTD. |
| K002099 |
07/11/2000 |
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- |
BESCON CO., LTD. |
| K992339 |
07/13/1999 |
COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS |
COLORSOFT LABORATORIES CORP. |
| K022373 |
07/22/2002 |
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS |
CANTOR & NISSEL LTD. |
| K032256 |
07/22/2003 |
QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE |
NO 7 CONTACT LENS LABORATORY LTD. |
| K992500 |
07/26/1999 |
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS |
CANTOR & SILVER LTD. |
| K992589 |
08/02/1999 |
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY |
OPTI-CENTRE LABORATORIES |
| K062332 |
08/10/2006 |
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION |
ALTAIRE PHARMACEUTICALS, INC. |
| K052290 |
08/23/2005 |
AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS |
CLEARLAB PTE LTD. |
| K002647 |
08/24/2000 |
MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS |
MARIETTA CONTACT LENS SERVICE |
| K963512 |
08/30/1996 |
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL |
BENZ RESEARCH AND DEVELOPMENT CORP. |
| K062548 |
08/30/2006 |
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES |
CONTAMAC LTD. |
| K983053 |
09/01/1998 |
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) |
ALDEN OPTICAL LABS., INC. |
| K963744 |
09/17/1996 |
BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK) |
BENZ RESEARCH AND DEVELOPMENT CORP. |
| K983278 |
09/17/1998 |
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) |
ALDEN OPTICAL LABS., INC. |
| K973597 |
09/22/1997 |
AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS |
MARTIN DALSING |
| K052606 |
09/22/2005 |
MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS |
MARIETTA VISION |
| K013220 |
09/26/2001 |
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) |
POLY VUE TECHNOLGIES, INC. |
| K954524 |
09/29/1995 |
W-55 (METHAFILON A) CONTACT LENS |
WESTCON CONTACT LENS CO., INC. |
| K102895 |
09/30/2010 |
ONE DAY FLAT PACK |
MENICON CO. LTD. |
| K983496 |
10/05/1998 |
RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T |
OPTI-CENTRE LABORATORIES |
| K023349 |
10/07/2002 |
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
| K973967 |
10/17/1997 |
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) |
ALDEN OPTICAL LABS., INC. |
| K983773 |
10/26/1998 |
BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS |
BENZ RESEARCH AND DEVELOPMENT CORP. |
| K133403 |
11/06/2013 |
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS |
FIRESTONE OPTICS, INC. |
| K033594 |
11/13/2003 |
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES |
CONTAMAC LTD. |
| K984098 |
11/17/1998 |
ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS |
ADVENTURES IN COLOR TECHNOLOGY, LTD. |
| K023987 |
12/02/2002 |
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
| K023989 |
12/02/2002 |
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
| K024045 |
12/06/2002 |
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
| K974599 |
12/09/1997 |
ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS) |
OPTI-CENTRE LABORATORIES |
| K003861 |
12/13/2000 |
BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) |
BENZ RESEARCH AND DEVELOPMENT CORP. |
| K994320 |
12/22/1999 |
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES |
CANTOR & SILVER LTD. |
| K073621 |
12/26/2007 |
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT |
ART OPTICAL CONTACT LENS, INC. |
| K004049 |
12/29/2000 |
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS) |
OPTECH, INC. |
| K111267 |
05/04/2011 |
CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) |
ABBCONCISE OPTICAL GROUP, LLC |
| K970145 |
01/15/1997 |
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) |
BIOSEARCH MEDICAL PRODUCTS, INC. |
| K090716 |
03/18/2009 |
BEGO SEMADOS S-LINE |
BEGO IMPLANT SYSTEMS GMBH & CO. KG |
| K970340 |
01/29/1997 |
AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER |
BELLAB |
| K000962 |
03/24/2000 |
PICO SMOKERLYZER, MODEL EC-50 |
BEDFONT SCIENTIFIC LTD. |
| K130144 |
01/22/2013 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
| K120197 |
01/23/2012 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
| K130236 |
01/30/2013 |
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 |
RADIOMETER MEDICAL APS |
| K130415 |
02/19/2013 |
HIGH METABOLITE QUALICHECK |
RADIOMETER MEDICAL APS |
| K081498 |
05/29/2008 |
TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 |
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG |
| K111897 |
07/05/2011 |
ABL90 |
RADIOMETER MEDICAL APS |
| K072205 |
08/08/2007 |
VISAGE PACS/CS, RELEASE VERSION 5.0 |
MERCURY COMPUTER SYSTEMS, INC |
| K122642 |
08/29/2012 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
| K122729 |
09/06/2012 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
| K181095 |
04/26/2018 |
RF-Relief |
EL Global Trade Ltd |
| K181121 |
04/30/2018 |
Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro |
Home Well Trading LTD |
| K181734 |
07/02/2018 |
Beurer IPL 8500 device/ IPL VelvetSkin Pro |
Home Well Trading LTD |
| K012771 |
08/17/2001 |
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX |
PAJUNK GMBH |
| K011997 |
06/27/2001 |
MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX |
PAJUNK GMBH |
| K081118 |
04/21/2008 |
NORAS MR-BI320-PA 1.5T |
NORAS MRI PRODUCTS GMBH |
| K013585 |
10/30/2001 |
MEDIPORT 2000 MOBILE |
SERVOX MEDIZINTECHNIK GMBH |
| K141164 |
05/05/2014 |
ARTEMIS LIGHT ENGINE |
QUEST MEDICAL IMAGING |
| K143474 |
12/05/2014 |
Artemis Hand Held Imaging System |
QUEST MEDICAL IMAGING |
| K182013 |
07/27/2018 |
EasyInstruments |
Agency for Medical Innovations GmbH |
| K212659 |
08/23/2021 |
More-Cell-System |
Agency for Medical Innovations GmbH |
| K182664 |
09/25/2018 |
FiXcision |
Agency for Medical Innovations GmbH |
| K090037 |
01/06/2009 |
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG |
MEDICALGORITHMICS SP Z.O.O. |
| K112921 |
10/03/2011 |
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM |
MEDICAL.GORITHMICS S.A. |
| K124060 |
12/31/2012 |
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM |
MEDICALGORITHMICS S.A. |
| K153283 |
11/12/2015 |
VivoSight Dx Topical OCT System |
Michelson Diagnostics Ltd |
| K093520 |
11/13/2009 |
VIVOSIGHT TOPICAL OCT SYSTEM |
MICHELSON DIAGNOSTICS LTD. |
| K101285 |
05/07/2010 |
CONSTELLATION VISION SYSTEM |
ALCON MANUFACTURING, LTD. |
| K220016 |
01/05/2022 |
Viramed Borrela All-In-One ViraChip Test Kit |
Viramed Biotech AG |
| K163695 |
12/28/2016 |
Borrelia B31 ViraChip IgM Test Kit |
Viramed Biotech AG |
| K163504 |
12/14/2016 |
Borrelia B31 ViraChip IgG Test Kit |
VIRAMED BIOTECH AG |
| K201827 |
07/02/2020 |
GR-17 Resin System |
Pro3dure Medical GmbH |
| K170221 |
01/25/2017 |
syngo.CT Cardiac Planning |
Siemens Healthcare GmbH |
| K152727 |
09/22/2015 |
ISEN-Goggles |
ISEN TECH & TRADING COMPANY, LTD. |
| K163270 |
11/21/2016 |
ISEN-Goggles with Data Viewer |
ISENT TECH & TRADING COMPANY,LTD. |
| K060995 |
04/11/2006 |
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 |
DUCKWORTH & KENT, LTD. |
| K081382 |
05/16/2008 |
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 |
DUCKWORTH & KENT, LTD. |
| K042478 |
09/13/2004 |
CAPSULE TENSION RING INSERTER, MODEL 7-810 |
DUCKWORTH & KENT, LTD. |
| K072985 |
10/23/2007 |
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 |
DUCKWORTH & KENT, LTD. |
| K053176 |
11/14/2005 |
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 |
DUCKWORTH & KENT, LTD. |
| K024072 |
12/10/2002 |
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM |
DUCKWORTH & KENT, LTD. |
| K011488 |
05/15/2001 |
SPIRABRUSH CX BIOPSY INSTRUMENT |
TRYLON CORP. |
| K003995 |
12/26/2000 |
SPECULITE/ORALLITE |
TRYLON CORP. |
| K100620 |
03/04/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 |
HARVARD MEDICAL DEVICES LTD. |
| K092557 |
08/20/2009 |
DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES |
HARVARD MEDICAL DEVICES LTD. |
| K092558 |
08/20/2009 |
WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES |
HARVARD MEDICAL DEVICES LTD. |
| K070532 |
02/26/2007 |
SPIROS |
ICU MEDICAL, INC |
| K063784 |
12/21/2006 |
DYE MANAGEMENT SYSTEM |
ICU MEDICAL, INC |
| DEN120001 |
01/12/2012 |
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE |
PHADIA US INC. |
| K140225 |
01/29/2014 |
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO |
PHADIA US INC. |
| K100999 |
04/12/2010 |
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 |
PHADIA AB |
| K121156 |
04/16/2012 |
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES |
PHADIA AB |
| K101251 |
05/04/2010 |
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN |
PHADIA AB |
| K121463 |
05/17/2012 |
IMMUNOCAP ALLERGEN K82 |
Thermo Fisher Scientific |
| K081830 |
06/30/2008 |
IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 |
PHADIA AB |
| K092050 |
07/07/2009 |
IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 |
PHADIA AB |
| K111919 |
07/07/2011 |
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS |
PHADIA US INC. |
| K122197 |
07/24/2012 |
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES |
PHADIA US INC. |
| K072149 |
08/03/2007 |
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 |
PHADIA US INC. |
| K092978 |
09/28/2009 |
IMMUNOCAP RAPID READER, MODEL 12-3600-10 |
PHADIA US INC. |
| K123275 |
10/19/2012 |
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM |
PHADIA AB |
| K113841 |
12/28/2011 |
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE |
PHADIA US INC. |
| K231096 |
04/18/2023 |
Automatic Continuous Effusion Shunt (ACES) System ACES System |
Pleural Dynamics, Inc. |
| K961105 |
03/20/1996 |
SKIN DOSE MONITOR |
MCMAHON MEDICAL |
| K150843 |
03/30/2015 |
syngo«.via (version VB10A) |
Siemens AG |
| K151182 |
05/04/2015 |
LiquiBand Exceed |
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
| K211878 |
06/21/2021 |
LiquiBand XL |
Advanced Medical Solutions Limited |
| K023690 |
11/01/2002 |
CATHETER CONNECTOR |
WORLD METALS, INC, |
| K183570 |
12/21/2018 |
LiquiBand Plus |
Advanced Medical Solutions Limited |
| K970217 |
01/21/1997 |
VISTA ILLUMINATION SYSTEM |
VISTA MEDICAL TECHNOLOGIES, INC. |
| K970214 |
01/21/1997 |
3 DIMENSIONAL VIDEO ENDOSCOPE |
OKTAS |
| K970369 |
01/31/1997 |
VISTA MINI CAMERA SYSTEM |
OKTAS |
| K200849 |
03/31/2020 |
Tempus LS - Manual |
Remote Diagnostic Technologies, Ltd, a Philips Company |
| K971373 |
04/14/1997 |
VISTA SINGLE CHIP VIDEO CAMERA |
VISTA MEDICAL TECHNOLOGIES, INC. |
| K973436 |
09/10/1997 |
VISTA HEAD MOUNTED DISPLAY |
VISTA MEDICAL TECHNOLOGIES, INC. |
| K013857 |
11/21/2001 |
AIMSTEP PREGNANCY |
GERMAINE LABORATORIES, INC. |
| K980531 |
02/11/1998 |
AIMSTEP PREGNANCY |
GERMAINE LABORATORIES, INC. |
| K981165 |
03/31/1998 |
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST |
GERMAINE LABORATORIES, INC. |
| K070929 |
04/03/2007 |
ACON U120 URINE ANALYZER, MODEL U111-101 |
ACON LABORATORIES, INC. |
| K991369 |
04/20/1999 |
ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY |
GERMAINE LABORATORIES, INC. |
| K061559 |
06/05/2006 |
ACON URINALYSIS REAGENT STRIPS |
ACON LABORATORIES CO. |
| K051727 |
06/28/2005 |
AIMSTICK URINE REAGENT STRIPS |
GERMAINE LABORATORIES, INC. |
| K973825 |
10/07/1997 |
MIDSTREAM HOME REGNANCY TEST |
GERMAINE LABORATORIES, INC. |
| K974368 |
11/20/1997 |
AIMSTICK PBD PREGNANCY |
GERMAINE LABORATORIES, INC. |
| K974512 |
12/01/1997 |
AIMSTICK PBD COMBO PREGNANCY |
GERMAINE LABORATORIES, INC. |
| K122139 |
07/19/2012 |
SMITH & NEPHEW R3 CONSTRAINED LINERS |
SMITH & NEPHEW, INC. |
| K132296 |
07/23/2013 |
D-RAD SMART PACK |
SMITH & NEPHEW, INC. |
| K142520 |
09/08/2014 |
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software |
Smith & Nephew, Inc |
| K123159 |
10/09/2012 |
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS |
SMITH & NEPHEW, INC. |
| K010220 |
01/24/2001 |
XTRACTOR, MODEL M143 |
INSTRUMENTS MEDICAUX G.B., INC. |
| K022979 |
09/09/2002 |
LAPARETTE, MODEL LAP J L S H N |
INSTRUMENTS MEDICAUX G.B., INC. |
| K210860 |
03/23/2021 |
Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 |
GRI-Alleset, Inc |
| K172835 |
09/19/2017 |
GRI-Alleset Veress Needle |
GRI Medical and Electronic Technology Co., Ltd. |
| K200907 |
04/06/2020 |
Thales 3D Mr Scanner |
LAP GmbH Laser Applikationen |
| K173926 |
12/26/2017 |
DORADOnova MR3T |
LAP GmbH Laser Applikationen |
| K191418 |
05/28/2019 |
Multix Fusion Max |
Siemens Medical Solutions USA, Inc. |
| K181433 |
06/01/2018 |
MAGNETOM Vida |
Siemens Medical Solutions USA, Inc. |
| K182050 |
07/31/2018 |
Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch |
Siemens Medical Solutions USA, Inc. |
| K212621 |
08/18/2021 |
MAMMOVISTA B.smart |
Siemens Medical Solutions USA, Inc. |
| K182299 |
08/24/2018 |
MAGNETOM Aera |
Siemens Medical Solutions USA Inc. |
| K193089 |
11/06/2019 |
MULTIX Impact |
Siemens Medical Solutions USA, Inc. |
| K203340 |
11/12/2020 |
MULTIX Impact C |
Siemens Medical Solutions USA, Inc. |
| K203345 |
11/13/2020 |
MULTIX Impact |
Siemens Medical Solutions USA, Inc. |
| K193166 |
11/15/2019 |
MAMMOMAT Revelation |
Siemens Medical Solutions USA, Inc. |
| K183221 |
11/20/2018 |
MAGNETOM Amira, MAGNETOM Sempra |
Siemens Medical Solutions USA, Inc. |
| K173600 |
11/21/2017 |
MAGNETOM Amira |
Siemens Medical Solutions USA, Inc. |
| K183244 |
11/21/2018 |
MAGNETOM Lumina |
Siemens Medical Solutions USA, Inc. |
| K000529 |
02/17/2000 |
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) |
THE LIFESTYLE CO., INC. |
| K112414 |
08/22/2011 |
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY |
PHADIA US INC. |
| K132631 |
08/22/2013 |
EIA SMDP IMMUNOASSAY |
PHADIA US INC. |
| K083117 |
10/22/2008 |
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 |
PHADIA US INC. |
| K093459 |
11/06/2009 |
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 |
PHADIA US INC. |
| K963049 |
07/25/1996 |
STERI-AID KIT |
STERI-AID, INC. |
| K031510 |
05/14/2003 |
NIM-SPINE |
MEDTRONIC XOMED |
| K024316 |
12/26/2002 |
NIM-PRS |
MEDTRONIC XOMED, INC. |
| K200132 |
01/21/2020 |
Ashvins |
MedicalCommunications GmbH |
| K081838 |
06/30/2008 |
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING |
GISH BIOMEDICAL, INC. |
| K082082 |
07/23/2008 |
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING |
GISH BIOMEDICAL, INC. |
| K994346 |
12/23/1999 |
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM |
SENDX MEDICAL, INC. |
| K143151 |
11/03/2014 |
Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) |
BSN MEDICAL GMBH |
| K023186 |
09/24/2002 |
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY |
EXACTECH, INC. |
| K130813 |
03/25/2013 |
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS |
MENTOR CORP. |
| K061229 |
05/02/2006 |
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
| K032606 |
08/25/2003 |
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS |
EXACTECH, INC. |
| K182335 |
08/28/2018 |
CPX 4 Breast Tissue Expander with Smooth Surface |
Mentor Worldwide LLC |
| K010630 |
03/02/2001 |
Y-TZP POWDER AND PROCERA ALLZIRKON |
PROCERA SANDVIK, INC. |
| K001418 |
05/05/2000 |
ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S |
PROCERA SANDVIK, INC. |
| K201171 |
05/01/2020 |
LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable |
LEONI Fiber Optics, Inc. |
| K220529 |
02/24/2022 |
Merits P335 Powered Wheelchair |
Merits Health Products Co., LTD. |
| K000192 |
01/20/2000 |
E3 MICROPROB SERIES OF LASERS AND ACCESSORIES |
MARTIN URAM, MD |
| K974878 |
12/30/1997 |
E3 MICROPROBE |
MARTIN URAM, MD |
| K180375 |
02/12/2018 |
The IQoolTM Warm System |
Brain Cool AB |
| DEN210027 |
07/02/2021 |
The Cooral System |
BrainCool AB |
| K162523 |
09/09/2016 |
The IQool System |
BRAIN COOL AB |
| K232844 |
09/14/2023 |
The IQoolTM System |
BrainCool AB |
| K130165 |
01/23/2013 |
PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 |
ADVANCED PLANIMETRIC SERVICES, LLC |
| K191075 |
04/23/2019 |
Healy |
TimeWaver Production GmbH |
| K150362 |
02/12/2015 |
NuVasive CoRoent Small Interbody System |
NuVasive, Incorporated |
| K180498 |
02/26/2018 |
NuVasive Reline Fenestrated Screws, High V+ Bone Cement |
NuVasive, Incorporated |
| K180550 |
03/01/2018 |
NuVasive Monolith Cervical Corpectomy System |
NuVasive, Incorporated |
| K161230 |
05/02/2016 |
NuVasive Lumbar Interbody Implants |
NUVASIVE, INCORPORATED |
| K163491 |
12/12/2016 |
NuVasive CoRoent Small Interbody System |
NuVasive, Incorporated |
| K153782 |
12/31/2015 |
NuVasive« Lumbar Interbody Implants |
NUVASIVE, INCORPORATED |
| K170607 |
03/01/2017 |
!M1 |
Solutions For Tomorrow AB |
| K970033 |
01/03/1997 |
MONARCH IOL DELIVERY SYSTEM |
ALCON LABORATORIES |
| K980292 |
01/26/1998 |
CATARACT LIQUEFRACTURE DEVICE |
ALCON LABORATORIES |
| K981103 |
03/26/1998 |
TURBOSONICS LIMITED REUSE ULTRASONIC TIP |
ALCON LABORATORIES |
| K120912 |
03/26/2012 |
INFINITI(R) VISION SYSTEM |
ALCON MANUFACTURING, LTD. |
| K110951 |
04/04/2011 |
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA |
ALCON RESEARCH, LTD. |
| K981571 |
05/04/1998 |
MONARCH IOL DELIVERY SYSTEM |
ALCON LABORATORIES |
| K091777 |
06/17/2009 |
ALCON ULTRACHOPPER |
ALCON RESEARCH, LTD. |
| K962592 |
07/02/1996 |
OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS |
ALCON LABORATORIES |
| K112425 |
08/23/2011 |
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE |
ALCON MANUFACTURING, LTD. |
| K093210 |
10/13/2009 |
AQUALASE CAPSULE WASH TIP |
ALCON MANUFACTURING, LTD. |
| K093305 |
10/22/2009 |
ENHANCED ULTRA VIT PROBE |
ALCON RESEARCH, LTD. |
| K083191 |
10/29/2008 |
DETLOGIX ANNULOPLASTY RING, MODEL: 5100 |
EDWARDS LIFESCIENCES, LLC. |
| K955789 |
12/22/1995 |
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM |
ALCON LABORATORIES |
| K965185 |
12/24/1996 |
ACRYPAK FOLDER |
ALCON LABORATORIES |
| K990448 |
02/12/1999 |
THE.R.MO.FREE |
DENTAMAX, INC. |
| K983558 |
10/13/1998 |
ACETAL DENTAL/PREFORMED CLASP |
DENTAMAX, INC. |
| K151472 |
06/01/2015 |
NuVasive CoRoent Lumbar System |
NuVasive, Incorporated |
| K973560 |
09/19/1997 |
BONE GRAFT HARVESTER |
DS MFG., INC. |
| K203696 |
12/18/2020 |
RBknee |
Radiobotics ApS |
| K001620 |
05/25/2000 |
METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN |
METRO OPTICS OF AUSTIN, INC. |
| K010666 |
03/06/2001 |
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE |
MEDTRONIC XOMED, INC. |
| K010677 |
03/07/2001 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
| K031003 |
03/31/2003 |
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES |
MEDTRONIC XOMED, INC. |
| K011321 |
04/27/2001 |
MODIFICATION TO XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
| K041413 |
05/27/2004 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
| K091631 |
06/03/2009 |
ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW |
ASPYRA, INC. |
| K041523 |
06/08/2004 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
| K992282 |
07/07/1999 |
MICRO-FRANCE LIPOSUCTION CANNULAS |
XOMED, INC. |
| K041985 |
07/23/2004 |
XPS CURVED BUR |
MEDTRONIC XOMED, INC. |
| K002224 |
07/24/2000 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED |
| K992869 |
08/25/1999 |
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE |
XOMED, INC. |
| K002828 |
09/11/2000 |
XPS NITRO SYSTEM |
XOMED, INC. |
| K993112 |
09/17/1999 |
XOMED ENT RF SYSTEM |
XOMED, INC. |
| K002987 |
09/25/2000 |
REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE |
XOMED, INC. |
| K993653 |
10/29/1999 |
MICRO-FRANCE TROCARS AND ACCESSORIES |
XOMED, INC. |
| K993655 |
10/29/1999 |
MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS |
XOMED, INC. |
| K994262 |
12/17/1999 |
FRONTAL SINUS TREPHINATION CANNULA |
XOMED, INC. |
| K014165 |
12/19/2001 |
STIMULUS - DISSECTION INSTRUMENTS |
MEDTRONIC XOMED, INC. |
| K172445 |
08/14/2017 |
RoyalGuard Surgical Gown, i600, Breathable |
GRI Medical & electrical Technology Co., Ltd |
| K162442 |
08/31/2016 |
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 |
GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. |
| K163191 |
11/14/2016 |
ComfortGuard Surgical Gown, i600, Film Reinforced |
GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. |
| K040926 |
04/08/2004 |
ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 |
HUDSON DIAGNOSTIC IMAGING LLC |
| K011284 |
04/27/2001 |
THIN FILM DRESSING FOR ULTRASOUND EXAM |
MARTIN E. WENDELKEN |
| K022928 |
09/04/2002 |
HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS |
HUDSON DIAGNOSTIC IMAGING LLC |
| K980554 |
02/13/1998 |
ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) |
ALDEN OPTICAL LABS., INC. |
| K970615 |
02/18/1997 |
PROMED 55-G SOFT DAILY WEAR CONTACT LENS |
BIOMED DEVICES CORP. |
| K973847 |
10/08/1997 |
AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS |
MARTIN DALSING |
| K954567 |
09/29/1995 |
RTI MEDICAL |
RADIOLOGY TELENETWORK INTL. |
| K120909 |
03/26/2012 |
EC 2.7 ENDOSCOPIC CUTTER |
MEDTRONIC ADVANCED ENERGY, LLC |
| K091650 |
06/09/2009 |
AXS-590 SERIES |
SWR INTERNATIONAL, LTD |
| K071599 |
06/11/2007 |
EASYGUIDE |
KEYSTONE DENTAL, INC. |
| K101711 |
06/18/2010 |
CERULEAU ELECTROSURGICAL PROBE |
NUORTHO SURGICAL, INC |
| K111732 |
06/20/2011 |
AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER |
SALIENT SURGICAL TECHNOLOGIES, INC. |
| K042270 |
08/23/2004 |
STAT K IN VITRO DIAGNOSTIC TEST SYSTEM |
STAT CHEM, INC. |
| K981496 |
04/27/1998 |
COLOR-SLIDE RF |
SERADYN, INC. |
| K952544 |
06/02/1995 |
COLORSLIDER RUBELLA |
SERADYN, INC. |
| K012070 |
07/02/2001 |
ORALLITE COMPREHENSIVE EXAM TRAY |
TRYLON CORP. |
| K033033 |
09/26/2003 |
VIZILITE-BLUE ORAL EXAM KIT |
TRYLON CORP. |
| K102673 |
09/16/2010 |
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
PHADIA US INC. |
| K961532 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961533 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961534 |
04/22/1996 |
SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) |
SA SCIENTIFIC, INC. |
| K961535 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM |
SA SCIENTIFIC, INC. |
| K961538 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961539 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961540 |
04/22/1996 |
SAS SHIGELLA SONNEI GROUP D ANTISERUM |
SA SCIENTIFIC, INC. |
| K961541 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 8 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961542 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961543 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 9 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961546 |
04/22/1996 |
SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM |
SA SCIENTIFIC, INC. |
| K961547 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 14 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961548 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 15 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961549 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961551 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961553 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961554 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 10 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961556 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961531 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 13 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961559 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961537 |
04/22/1996 |
SAS SHIGELLA SONNEI FORM II ANTISERUM |
SA SCIENTIFIC, INC. |
| K961558 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961528 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) |
SA SCIENTIFIC, INC. |
| K140542 |
03/04/2014 |
NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER |
RHINOSYSTEMS, INC. |
| K140493 |
02/27/2014 |
ELIA SCL-70S IMMUNOASSAY |
PHADIA GMBH |
| K061165 |
04/26/2006 |
ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 |
SWEDEN DIAGNOSTICS (US), INC. |
| K051218 |
05/12/2005 |
MODIFICATION TO: UNICAP SPECIFIC IGE |
PHARMACIA DIAGNOSTICS AB |
| K131821 |
06/20/2013 |
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY |
PHADIA US INC. |
| K072393 |
08/27/2007 |
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 |
PHADIA US INC. |
| K062583 |
09/01/2006 |
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 |
PHADIA US INC. |
| K062787 |
09/18/2006 |
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 |
PHADIA US INC. |
| K072661 |
09/21/2007 |
IMMUNOCAP THYRLOBULIN IMMUNOCAP |
PHADIA US INC. |
| K082759 |
09/22/2008 |
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY |
PHADIA US INC. |
| K052793 |
10/03/2005 |
IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 |
PHARMACIA DIAGNOSTICS AB |
| K083188 |
10/29/2008 |
VARELISA RECOMBI ANA SCREEN, MODEL 12 596 |
PHADIA US INC. |
| K133404 |
11/06/2013 |
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH |
PHADIA AB |
| K063775 |
12/21/2006 |
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL |
PHADIA US INC. |
| K972663 |
07/08/1997 |
SMART SET |
TOPSPINS, INC. |
| K964968 |
12/12/1996 |
MR EXTENSION SET (001) |
UNIVERSITY OF MICHIGAN |
| K091845 |
06/22/2009 |
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM |
PHADIA US INC. |
| K010126 |
01/16/2001 |
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) |
CL-TINTERS |
| K980634 |
02/19/1998 |
FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) |
ASPECT VISION CARE, LTD. |
| K980818 |
03/03/1998 |
POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) |
STEPHEN A. DUNN, INC. |
| K971049 |
03/21/1997 |
FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) |
ASPECT VISION CARE, LTD. |
| K963011 |
08/02/1996 |
LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR |
PERMEABLE TECHNOLOGIES, INC. |
| K963010 |
08/02/1996 |
LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR |
PERMEABLE TECHNOLOGIES, INC. |
| K963001 |
08/02/1996 |
LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR |
PERMEABLE TECHNOLOGIES, INC. |
| K973063 |
08/18/1997 |
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR |
ASPECT VISION CARE, LTD. |
| K973192 |
08/25/1997 |
FLEXLENS, FLEXLENS TORIC |
SPECIALTY ULTRAVISION, INC. |
| K982997 |
08/27/1998 |
FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER) |
ASPECT VISION CARE, LTD. |
| K963764 |
09/19/1996 |
SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR |
SPECIALTY ULTRAVISION, INC. |
| K984259 |
11/30/1998 |
PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) |
CL-TINTERS |
| K982774 |
08/07/1998 |
SOFT (HYDROPHILIC) CONTACT LENSES |
CL-TINTERS |
| K203450 |
11/23/2020 |
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) |
CapNostics, LLC |
| K151432 |
05/28/2015 |
NaturalLine Abutment |
OT MEDICAL GMBH |
| K151608 |
06/15/2015 |
4plus6Line Abutment System |
OT MEDICAL GMBH |
| K032822 |
09/10/2003 |
ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0 |
ASAP ENDOSCOPIC PRODUCTS GMBH |
| K031141 |
04/10/2003 |
ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE |
ASAP ENDOSCOPIC PRODUCTS GMBH |
| K021250 |
04/19/2002 |
MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) |
HANDPIECE UNLIMITED |
| K031974 |
06/26/2003 |
ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 |
ASAP ENDOSCOPIC PRODUCTS GMBH |
| K031972 |
06/26/2003 |
ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, |
ASAP ENDOSCOPIC PRODUCTS GMBH |
| K051872 |
07/11/2005 |
MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 |
MK-DENT GMBH |
| K032234 |
07/21/2003 |
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K |
MK-DENT GMBH |
| K052492 |
09/12/2005 |
AIRNERGY+STREAM |
NATURAL ENERGY SOLUTIONS AG |
| K172600 |
08/30/2017 |
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal |
Alcon Laboratories, Inc. |
| K072777 |
09/28/2007 |
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES |
CIBA VISION CORPORATION |
| K182782 |
10/01/2018 |
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric |
Alcon Laboratories, Inc. |
| K083216 |
10/31/2008 |
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES |
CIBA VISION CORPORATION |
| K133176 |
10/17/2013 |
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL |
CIBA VISION CORPORATION |
| K123994 |
12/26/2012 |
DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL |
CIBA VISION CORPORATION |
| K181563 |
06/14/2018 |
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology |
Access Scientific, LLC |
| K182243 |
08/20/2018 |
The CVC WAND Safety Introducer with Valved Peelable Sheath |
Access Scientific, LLC |
| K183066 |
11/05/2018 |
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C« with BioGUARDÖ Technology-3 Fr, 4 Fr, and 5 Fr Model |
Access Scientific, LLC |
| K212379 |
08/02/2021 |
N Latex FLC kappa, N Latex FLC lambda |
Siemens Healthcare Diagnostics Products GmbH |
| K212559 |
08/13/2021 |
CardioPhase« hsCRP |
Siemens Healthcare Diagnostics Products GmbH |
| K052411 |
08/29/2005 |
HIPAX MEDICAL IMAGING SOFTWARE |
STEINHART MEDIZINSYSTEME GMBH |
| K080760 |
03/18/2008 |
ACUSON X300 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K071036 |
04/12/2007 |
MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K081121 |
04/21/2008 |
MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K071314 |
05/10/2007 |
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K072676 |
09/21/2007 |
ACUSON X300 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K223907 |
12/28/2022 |
NuEra Tight RF Model APMD145.M70-US |
BIOS s.r.l. |
| K171576 |
05/30/2017 |
The Panthera Anti-Snoring X3 Device |
Panthera Dental Inc. |
| K192108 |
08/05/2019 |
Panthera Dental Milled Bars |
Panthera Dental Inc. |
| K173466 |
11/08/2017 |
Panthera Dental Milled Bars |
Panthera Dental Inc. |
| K203596 |
12/09/2020 |
Panthera Occlusal Appliance |
Panthera Dental Inc. |
| K183580 |
12/21/2018 |
Panthera Dental Milled Bars |
Panthera Dental Inc. |
| K955886 |
12/28/1995 |
MEGA PTA BALLOON CATHETER |
CORDIS CORP. |
| K991134 |
04/02/1999 |
ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR |
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| K991163 |
04/07/1999 |
VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR |
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| K970299 |
01/27/1997 |
JUPITER PTA CATHETERS (VARIOUS) |
CORDIS CORP. |
| K030558 |
02/21/2003 |
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY |
PROXIMA THERAPEUTICS, INC. |
| K011690 |
05/31/2001 |
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY |
PROXIMA THERAPEUTICS, INC. |
| K032067 |
07/03/2003 |
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY |
PROXIMA THERAPEUTICS, INC. |
| K041929 |
07/19/2004 |
MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY |
PROXIMA THERAPEUTICS, INC. |
| K982632 |
07/23/1998 |
ENVOY AND VISTA BRITE TIP |
CORDIS CORP. |
| K982770 |
07/23/1998 |
6F ENVOY GUIDING CATHETER |
CORDIS CORP. |
| K983003 |
08/28/1998 |
1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS |
CORDIS NEUROVASCULAR, INC. |
| K983483 |
10/05/1998 |
VASCULAR OCCLUSION SYSTEM |
CORDIS NEUROVASCULAR, INC. |
| K073262 |
11/20/2007 |
BELLA |
BEEKLEY CORP. |
