K213223 |
09/29/2021 |
Multi-Band Ligator |
Beijing ZKSK Technology Co.,Ltd |
K213222 |
09/29/2021 |
Disposable Polypectomy Snare |
Beijing ZKSK Technology Co.,Ltd |
K213217 |
09/29/2021 |
Disposable hemoclip |
Beijing ZKSK Technology Co.,Ltd |
K213239 |
09/30/2021 |
Endoscopic Injection Needle |
Beijing ZKSK Technology Co.,Ltd |
K171553 |
05/30/2017 |
W&H Assistina Twin |
W & H Dentalwerk Buermoos GmbH |
K140478 |
02/26/2014 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
Tornier SAS |
K132285 |
07/23/2013 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
TORNIER, SAS |
K172925 |
09/25/2017 |
Contact Lens Case, Model: A-1, B-1 |
P L Overseas Limited |
K153582 |
12/15/2015 |
Prometheus ChitoGauze XR PRO |
HEMCON MEDICAL TECHNOLOGIES, INC. |
K170958 |
03/31/2017 |
ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm |
Tricol Biomedical Inc. |
K120209 |
01/24/2012 |
PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE |
AMERICAN I.V. PRODUCTS, INC. |
K161768 |
06/27/2016 |
LUCAS 3 Chest Compression System |
Jolife AB |
K173553 |
11/16/2017 |
LUCAS 3 Chest Compression System |
Jolife AB |
K100066 |
01/11/2010 |
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 |
WELLDOC, INC |
K041671 |
06/21/2004 |
IMAGENMD |
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC |
K173765 |
12/11/2017 |
Surveyor Patient Monitor |
Mortara Instrument, Inc. |
K170875 |
03/24/2017 |
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories |
Intuitive Surgical, Inc. |
K191043 |
04/19/2019 |
da Vinci Handheld Camera |
Intuitive Surgical, Inc. |
K222894 |
09/23/2022 |
Invisalign System, Pre-Formed Attachment System |
Align Technology, Inc. |
K120010 |
01/03/2012 |
CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) |
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
K962655 |
07/08/1996 |
ANEROID AND MERCURIAL SPHYGMOMANOMETERS |
AMERICAN DIAGNOSTIC CORP. |
K012304 |
07/20/2001 |
ADC 656 ELECTRONIC STETHOSCOPE |
AMERICAN DIAGNOSTIC CORP. |
K030073 |
01/08/2003 |
VERMED A10021 RESTING EKG TAB ELECTRODE |
VERMONT MEDICAL, INC. |
K090180 |
01/23/2009 |
TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE |
VERMED, INC. |
K010638 |
03/05/2001 |
NEUROPLUS, MODEL A10040, A10041, A10042, A10043 |
VERMONT MEDICAL, INC. |
K021537 |
05/10/2002 |
MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 |
VERMONT MEDICAL, INC. |
K161337 |
05/13/2016 |
CryoDose H or Similar |
NUANCE MEDICAL, LLC |
K172203 |
07/21/2017 |
CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray |
Nuance Medical, LLC |
K162218 |
08/08/2016 |
Pain FreezeÖ, Medium Stream Spray, Model #2101; Pain FreezeÖ, Mist Spray, Model #2102 |
NUANCE MEDICAL, LLC |
K220331 |
02/04/2022 |
091 Balloon Guide Catheter |
InNeuroCo Inc. |
K190338 |
02/14/2019 |
046 Zenith Flex |
InNeuroCo, Inc |
K161262 |
05/05/2016 |
Super Distal Access (SDA) |
INNEUROCO, INC |
K181354 |
05/22/2018 |
074 Zenith Flex System |
InNeuroCo Inc. |
K171672 |
06/06/2017 |
065 Zenith, 074 Zenith |
InNeuroCo, Inc |
K172167 |
07/18/2017 |
Zenith Flex System |
InNeuroCo, Inc. |
K232260 |
07/31/2023 |
Thinline Sheath Introducer |
Inneuroco Inc. |
K172468 |
08/15/2017 |
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm |
InNeuroCo, Inc |
K173709 |
12/04/2017 |
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm |
InNeuroCo, Inc |
K112595 |
09/07/2011 |
COFLEX-F |
PARADIGM SPINE, LLC |
K153302 |
11/13/2015 |
coflex-IF |
PARADIGM SPINE, LLC |
K131279 |
05/06/2013 |
ICONACY I-HIP SYSTEM |
ICONACY ORTHOPEDIC IMPLANTS, LLC |
K132572 |
08/15/2013 |
I-HIP TOTAL HIP SYSTEM |
ICONACY ORTHOPEDIC IMPLANTS, LLC |
K133228 |
10/21/2013 |
ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM |
ICONACY ORTHOPEDIC IMPLANTS, LLC |
K130995 |
04/10/2013 |
NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY |
NUANCE MEDICAL, LLC |
K021931 |
06/12/2002 |
ENDOSCOPIC FIBEROPTIC CABLE |
GULF MEDICAL FIBEROPTICS |
K061690 |
06/15/2006 |
SURGICAL HEADLIGHT |
GULF MEDICAL FIBEROPTICS |
K012347 |
07/24/2001 |
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
SULZER INTRATHERAPEUTICS, INC. |
K192077 |
08/02/2019 |
Tua Face Fitness / Tua Trend Face |
Vupiesse S.R.L |
K172825 |
09/18/2017 |
MN-111 |
W&H Sterilization s.r.l. |
K120051 |
01/06/2012 |
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML |
NEPHRON PHARMACEUTICALS CORP. |
K113033 |
10/12/2011 |
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML |
NEPHRON PHARMACEUTICALS CORP. |
K190402 |
02/19/2019 |
Triathlon Total Knee System-Additional Components |
Stryker Orthopaedics (aka Howmedica Osteonics Corp.) |
K220838 |
03/22/2022 |
Artisan Bone Plug, Universal Cement Restrictor |
Howmedica Osteonics, dba Stryker Orthopaedics |
K222056 |
07/12/2022 |
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
K212187 |
07/13/2021 |
Restoration« Modular Hip System |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
K202016 |
07/21/2020 |
Dall-Miles« Cable System |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
K172326 |
08/01/2017 |
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System |
Stryker Orthopaedics |
K222632 |
08/31/2022 |
UHR Bipolar Implants, Restoration GAP II Implants |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
K223069 |
09/30/2022 |
Modular Rotating Hinge Knee Systems and Compatible Components |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
K153345 |
11/19/2015 |
Stryker Orthopaedics Hip Systems Labeling Update |
STRYKER ORTHOPAEDICS |
K143393 |
11/26/2014 |
Triathlon Tritanium Cone Augments |
STRYKER ORTHOPAEDICS |
K173849 |
12/19/2017 |
Triathlon Total Knee System |
Stryker Orthopaedics |
K113565 |
12/02/2011 |
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN |
EDWARDS LIFESCIENCES, LLC. |
K170168 |
01/19/2017 |
Masimo Rad-97 and Accessories |
MASIMO CORPORATION |
K110167 |
01/20/2011 |
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) |
EDWARDS LIFESCIENCES, LLC. |
K090165 |
01/22/2009 |
RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 |
MASIMO CORPORATION |
K140188 |
01/24/2014 |
MASIMO ROOT MONITORING SYSTEM |
MASIMO CORPORATION |
K150314 |
02/09/2015 |
Masimo MightySat Rx Fingertip Pulse Oximeter |
MASIMO CORPORATION |
K100428 |
02/16/2010 |
MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER |
MASIMO CORPORATION |
K100403 |
02/16/2010 |
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 |
MASIMO CORPORATION |
K160526 |
02/25/2016 |
Masimo O3 Regional Oximeter System |
MASIMO CORPORATION |
K110597 |
03/02/2011 |
EV1000 CLINICAL PLATFORM |
EDWARDS LIFESCIENCES |
K100617 |
03/04/2010 |
MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D |
MASIMO CORPORATION |
K090662 |
03/12/2009 |
MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP |
MASIMO CORPORATION |
K160940 |
04/04/2016 |
Masimo Disposable Transflectance Forehead Sensor |
Masimo Corporation |
K071047 |
04/13/2007 |
MASIMO PATIENT SAFETY NET |
MASIMO CORPORATION |
K091057 |
04/13/2009 |
MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES |
MASIMO CORPORATION |
K101031 |
04/13/2010 |
MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 |
MASIMO CORPORATION |
K171121 |
04/17/2017 |
Masimo Root Monitoring System and Accessories |
Masimo Corporation |
K091241 |
04/27/2009 |
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER |
MASIMO CORPORATION |
K081659 |
06/12/2008 |
RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L |
MASIMO CORPORATION |
K151644 |
06/18/2015 |
Masimo Root Vital Signs Monitoring System and Accessories |
MASIMO CORPORATION |
K101896 |
07/07/2010 |
MASIMO LNCS/M-LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
K082052 |
07/21/2008 |
MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK |
MASIMO CORPORATION |
K122381 |
08/06/2012 |
NEXFIN MODEL 2 |
EDWARDS LIFESCIENCES, LLC. |
K142394 |
08/27/2014 |
Masimo Root Monitoring System and Accesories |
MASIMO CORPORATION |
K092838 |
09/15/2009 |
MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 |
MASIMO CORPORATION |
K162603 |
09/19/2016 |
Masimo O3 Regional Oximeter System |
MASIMO CORPORATION |
K162675 |
09/26/2016 |
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter |
MASIMO CORPORATION |
K103094 |
10/19/2010 |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
K073024 |
10/26/2007 |
MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES |
MASIMO CORPORATION |
K153225 |
11/06/2015 |
Masimo Root Monitoring System and Accessories |
Masimo Corporation |
K083622 |
12/08/2008 |
LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
K083719 |
12/15/2008 |
LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
K094046 |
12/31/2009 |
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
K232569 |
08/24/2023 |
CAREMIBRAIN |
General Equipment for Medical Imaging, S.A. |
K120884 |
03/23/2012 |
PERICAM PSI |
PERIMED AB |
K131253 |
05/02/2013 |
PERIFLUX 6000 |
PERIMED AB |
K213442 |
10/25/2021 |
Extroducer Infusion Catheter System |
Smartwise Sweden AB |
DEN110012 |
04/13/2011 |
APTIMA TRICHOMONAS VAGINALIS ASSAY |
GEN-PROBE INCORPORATED |
K122062 |
07/13/2012 |
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER |
GEN-PROBE, INC. |
K052513 |
09/14/2005 |
BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 |
DELTA ENTERPRISE CORPORATION |
K152930 |
10/05/2015 |
PeriFlux6000 |
PERIMED AB |
K013133 |
09/19/2001 |
NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 |
NORDIX, INC. |
K142419 |
08/28/2014 |
Mini and Micro Fragments Reconstruction System-NEOFIX |
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A |
K162874 |
10/13/2016 |
Cannulated Screws Neoortho |
Neoortho Produtos Ortopedicos S/A |
K180204 |
01/24/2018 |
CranioMaxillofacial Fixation (CMF) System - CMF Visionare |
Visionare LLC |
K113705 |
12/16/2011 |
PINTLER PATIENT WARMING SYSTEM |
PINTLER MEDICAL |
K090844 |
03/27/2009 |
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
K081008 |
04/10/2008 |
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS |
Lin-Zhi International, Inc. |
K050988 |
04/19/2005 |
OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
K062242 |
08/02/2006 |
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
K063024 |
10/02/2006 |
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
K142894 |
10/03/2014 |
TCS Blend |
Thermoplastic Comfort Systems, Inc. |
K053060 |
10/31/2005 |
TCS UNBREAKABLE |
THERMOPLASTIC COMFORT SYSTEMS, INC. |
K180513 |
02/27/2018 |
CustomizedBone Service |
Fin-Ceramica Faenza S.p.A |
K171507 |
05/23/2017 |
CustomizedBone Service |
Fin-ceramica faenza spa |
K193547 |
12/20/2019 |
CustomizedBone Service |
Fin-Ceramica Faenza Spa |
K210127 |
01/19/2021 |
iQ200 System, iChemVELOCITY Automated Urine Chemistry System |
Beckman Coulter, Inc. |
K060107 |
01/13/2006 |
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS |
EXACTECH, INC. |
K110327 |
02/03/2011 |
LDR SPINE ROI-A INTERBODY FUSION SYSTEM |
LDR SPINE USA |
K070479 |
02/20/2007 |
EXACTECH NOVATION CROWN CUP AND LINERS |
EXACTECH, INC. |
K051335 |
05/23/2005 |
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS |
EXACTECH, INC. |
K061454 |
05/25/2006 |
EXACTECH EQUINOXE SHOULDER STEMS |
EXACTECH, INC. |
K081622 |
06/10/2008 |
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM |
ABBOTT SPINE, INC. |
K061668 |
06/14/2006 |
OPTECURE +CCC |
EXACTECH, INC. |
K051682 |
06/23/2005 |
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM |
EXACTECH, INC. |
K052787 |
10/03/2005 |
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) |
EXACTECH, INC. |
K123134 |
10/05/2012 |
EASYSPINE SYSTEM |
LDR SPINE USA INC. |
K063279 |
10/31/2006 |
NOVATION SPLINED RDD FEMORAL STEMS |
EXACTECH, INC. |
K113285 |
11/07/2011 |
LDR SPINE USA AVENUE L INTERBODY FUSION |
LDR SPINE USA INC. |
K073202 |
11/13/2007 |
ARDIS SPACER |
ABBOTT SPINE, INC. |
K063685 |
12/12/2006 |
OPTECURE; OPTECURE + CCC |
EXACTECH, INC. |
K172457 |
08/14/2017 |
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM |
Deltex Medical Limited |
K072053 |
07/26/2007 |
SMARTBLOCK PAIN PUMP |
MEDICAL FLOW SYSTEMS LTD |
K984129 |
11/18/1998 |
COAGULATION CONTROL LEVEL 1 (NORMAL) |
PACIFIC HEMOSTASIS |
K984131 |
11/18/1998 |
COAGULATION CONTROL LEVEL 3 (ABNORMAL) |
PACIFIC HEMOSTASIS |
K984130 |
11/18/1998 |
COAGULATION CONTROL LEVEL 2 (ABNORMAL) |
PACIFIC HEMOSTASIS |
K221361 |
05/11/2022 |
circulÖ pro Ring |
BodiMetrics, LLC |
K222158 |
07/20/2022 |
Capiflo 5001 |
K&L Distributing, Inc. |
K960836 |
02/29/1996 |
DMS-9000 |
O.R. SOLUTIONS, INC. |
K020710 |
03/05/2002 |
BIOTEST HEMOGLOBIN MEASURING SYSTEM |
BIOTEST MEDIZINTECHNIK GMBH |
K061060 |
04/17/2006 |
TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8 |
TISSUE TECHNOLOGIES HOLDINGS, LLC |
K972781 |
07/25/1997 |
OT-1 |
PRISM THERAPEUTICS, LLC. |
K043038 |
11/04/2004 |
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML |
BIOTOP TECHNOLOGY CO., LTD. |
K060342 |
02/10/2006 |
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K |
ROSSMAX INTERNATIONAL LTD. |
K981231 |
04/03/1998 |
CO2 |
ABBOTT MFG., INC. |
K990035 |
01/06/1999 |
RF |
ABBOTT LABORATORIES |
K981118 |
03/27/1998 |
PHOS |
ABBOTT LABORATORIES |
K991175 |
03/29/1999 |
MODIFICATION TO ALCYON DIRECT BILIRUBIN |
ABBOTT LABORATORIES |
K981192 |
04/02/1998 |
MG |
ABBOTT LABORATORIES |
K981189 |
04/02/1998 |
URIC ACID |
ABBOTT LABORATORIES |
K981185 |
04/02/1998 |
GLU |
ABBOTT LABORATORIES |
K981221 |
04/03/1998 |
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) |
ABBOTT LABORATORIES |
K981224 |
04/03/1998 |
DIRECT HDL |
ABBOTT LABORATORIES |
K981222 |
04/03/1998 |
DIRECT BILIRUBIN (DBIL) |
ABBOTT LABORATORIES |
K981218 |
04/03/1998 |
CREATINE KINASE (CK) |
ABBOTT LABORATORIES |
K981232 |
04/03/1998 |
CA |
ABBOTT MFG., INC. |
K981225 |
04/03/1998 |
ASPARTATE AMINOTRANSFERASE (AST) |
ABBOTT LABORATORIES |
K981216 |
04/03/1998 |
AMY |
ABBOTT LABORATORIES |
K981245 |
04/06/1998 |
ALKALINE PHOSPHATASE (ALKP) |
ABBOTT LABORATORIES |
K981241 |
04/06/1998 |
IRON |
ABBOTT LABORATORIES |
K981240 |
04/06/1998 |
CREATININE (CREA) |
ABBOTT LABORATORIES |
K981279 |
04/08/1998 |
TIBC |
ABBOTT LABORATORIES |
K981295 |
04/09/1998 |
UPRO |
ABBOTT LABORATORIES |
K981303 |
04/10/1998 |
DIRECT LDL |
ABBOTT LABORATORIES |
K981336 |
04/13/1998 |
TBIL |
ABBOTT LABORATORIES |
K981468 |
04/23/1998 |
ALBG |
ABBOTT LABORATORIES |
K981457 |
04/23/1998 |
ALBP |
ABBOTT MFG., INC. |
K981467 |
04/23/1998 |
AMM |
ABBOTT LABORATORIES |
K981476 |
04/24/1998 |
CHOL |
ABBOTT LABORATORIES |
K981578 |
05/04/1998 |
CA |
ABBOTT LABORATORIES |
K981580 |
05/04/1998 |
HDL |
ABBOTT LABORATORIES |
K981581 |
05/04/1998 |
IRON |
ABBOTT LABORATORIES |
K981654 |
05/11/1998 |
TIBC |
ABBOTT LABORATORIES |
K981653 |
05/11/1998 |
AMY |
ABBOTT LABORATORIES |
K981652 |
05/11/1998 |
CHOL |
ABBOTT LABORATORIES |
K981682 |
05/13/1998 |
UPRO |
ABBOTT LABORATORIES |
K981706 |
05/14/1998 |
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 |
ABBOTT LABORATORIES |
K981766 |
05/19/1998 |
URIC ACID |
ABBOTT LABORATORIES |
K981758 |
05/19/1998 |
ALBG |
ABBOTT LABORATORIES |
K981759 |
05/19/1998 |
PHOS |
ABBOTT LABORATORIES |
K981791 |
05/21/1998 |
MG |
ABBOTT LABORATORIES |
K981799 |
05/21/1998 |
CREA |
ABBOTT LABORATORIES |
K981814 |
05/22/1998 |
ALBP |
ABBOTT LABORATORIES |
K981843 |
05/26/1998 |
AST |
ABBOTT LABORATORIES |
K981840 |
05/26/1998 |
CO2 |
ABBOTT LABORATORIES |
K981920 |
06/01/1998 |
AMM |
ABBOTT LABORATORIES |
K981918 |
06/01/1998 |
UREA |
ABBOTT LABORATORIES |
K981943 |
06/03/1998 |
DBIL |
ABBOTT LABORATORIES |
K181748 |
07/02/2018 |
Magnesium |
Abbott Laboratories |
K993083 |
09/15/1999 |
ALCYON 300I (WITH ISE MODULE) ANALYZER |
ABBOTT LABORATORIES |
K093318 |
10/23/2009 |
ACCELERATOR APS |
ABBOTT LABORATORIES |
K963547 |
09/05/1996 |
THE WRAP IMMOBILIZATION SYSTEM |
SAFE RESTRAINTS, INC. |
K030366 |
02/04/2003 |
BICARD MIXING SYSTEM |
DIALYSIS SYSTEMS, INC. |
K212499 |
08/09/2021 |
BD Insulin Syringe (0.3mL) |
Becton, Dickinson and Company |
K213156 |
09/20/2021 |
BD Nano 2nd Gen Pen Needle |
Becton, Dickinson and Company |
K220132 |
01/18/2022 |
FIREFLY« Cervical Navigation Guide |
Mighty Oak Medical Inc. |
K181399 |
05/29/2018 |
FIREFLY« Pedicle Screw Navigation Guide |
Mighty Oak Medical Inc. |
K181883 |
07/13/2018 |
FIREFLY« Midline Navigation Guide |
Mighty Oak Medical Inc. |
K162419 |
08/30/2016 |
FIREFLY« Pedicle Screw Navigation Guide |
MIGHTY OAK MEDICAL INC. |
K080555 |
02/28/2008 |
SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) |
IVU IMAGING CORPORATION |
K123396 |
11/05/2012 |
I.FLEX BY TCS |
THERMOPLASTIC COMFORT SYSTEMS, INC. |
K080238 |
01/31/2008 |
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER |
MASIMO CORPORATION |
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. |
K011514 |
05/17/2001 |
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE |
KENCAP LTD. |
K981353 |
04/14/1998 |
AVOGEL |
AVOCET POLYMER TECHNOLOGIES, INC. |
K121451 |
05/16/2012 |
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE |
MEDTRONIC INC. |
K970726 |
02/28/1997 |
VAPOCIDE |
COTTRELL, LTD. |
K022670 |
08/12/2002 |
CARRAKLENZ AND ULTRAKLENZ |
CARRINGTON LABORATORIES, INC. |
K030647 |
02/28/2003 |
EVA DIGITAL DENTAL X-RAY SYSTEM |
AFP IMAGING CORP. |
K990049 |
01/07/1999 |
CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000 |
DIGIDENT LTD. |
K050032 |
01/07/2005 |
EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS |
EUROMED, INC. |
K960089 |
01/11/1996 |
PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR |
COTTRELL, LTD. |
K030131 |
01/14/2003 |
OSSATURA BCP BONE VOID FILLER |
ISOTIS NV |
K960173 |
01/16/1996 |
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT |
GABRIEL MEDICAL, INC. |
K050187 |
01/27/2005 |
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES |
SOFRADIM PRODUCTION |
K080315 |
02/06/2008 |
DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY |
DERMA SCIENCES, INC. |
K050354 |
02/14/2005 |
PERIOSCAN ULTRASONIC SCALER |
SIRONA DENTAL SYSTEMS GMBH |
K000551 |
02/18/2000 |
IMAGE X-70 PLUS DENTAL X-RAY UNIT |
MEDICAL DEVICE CONSULTANTS, INC. |
K090411 |
02/18/2009 |
FREEDOM METAL BACKED TIBIAL COMPONENT |
MAXX ORTHOPEDICS, INC. |
K060507 |
02/27/2006 |
VALPLAST YAMAHACHI TEETH |
VALPLAST INTL. CORP. |
K010711 |
03/09/2001 |
ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR |
ADVANCED SURGICAL CONCEPTS (ASC) |
K991011 |
03/26/1999 |
ORASCOPE |
FIBERDENT CORP. |
K020969 |
03/26/2002 |
VACURECT VACUUM CONSTRICTION DEVICE |
VACURECT MANUFACTURING (PTY) LTD. |
K080949 |
04/03/2008 |
KERATEC WOUND DRESSINGS |
KERATEC LIMITED |
K971369 |
04/14/1997 |
BROWNE MVI STEAM INDICATOR |
ALBERT BROWNE LTD. |
K011183 |
04/18/2001 |
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS (ASC) |
K071147 |
04/24/2007 |
NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM |
NEXA ORTHOPEDICS, INC. |
K061166 |
04/27/2006 |
DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM |
BIOWAVE CORPORATION |
K091280 |
05/01/2009 |
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT |
MAXX ORTHOPEDICS, INC. |
K061246 |
05/03/2006 |
ENDOSCOPIC SPINE SYSTEM |
ARTHRO KINETICS INC. |
K041176 |
05/05/2004 |
URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM |
SOFRADIM PRODUCTION |
K051160 |
05/05/2005 |
MANIPUSEAL |
INSITU SYSTEMS |
K971802 |
05/15/1997 |
VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION |
LOUISVILLE LABORATORIES, INC. |
K971796 |
05/15/1997 |
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS |
LOUISVILLE LABORATORIES, INC. |
K971801 |
05/15/1997 |
LAPAROTOMY BLADDER NECK SUSPENSION KIT |
LOUISVILLE LABORATORIES, INC. |
K971791 |
05/15/1997 |
VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION |
LOUISVILLE LABORATORIES, INC. |
K971797 |
05/15/1997 |
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT |
LOUISVILLE LABORATORIES, INC. |
K031584 |
05/21/2003 |
SIROTORQUE L |
SIRONA DENTAL SYSTEMS GMBH |
K981928 |
06/02/1998 |
GALILEO DISPOSABLE ENDOSCOPES |
GALILEO ELECTRO-OPTICS CORP. |
K051445 |
06/02/2005 |
MILLIKEN SILVER WOUND DRESSINGS |
MILLIKEN CHEMICAL |
K981958 |
06/04/1998 |
LEISEGANG VIDEO COLPOSCOPE |
NETOPTIX CORP. |
K081584 |
06/05/2008 |
DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY |
DERMA SCIENCES, INC. |
K981998 |
06/08/1998 |
PEDIATRIC INSTATRAK SYSTEM |
VISUALIZATION TECHNOLOGY, INC. |
K061615 |
06/09/2006 |
INTERDRY TEXTILE WITH SILVER |
MILLIKEN CHEMICAL |
K061614 |
06/09/2006 |
TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS |
ESCADA INTERNATIONAL, INC. |
K021913 |
06/11/2002 |
CALSCOR SOFTWARE |
3D MED CO., LTD. |
K962256 |
06/12/1996 |
GALILEO HYSTEROSCOPES AND LAPAROSCOPES |
GALILEO ELECTRO-OPTICS CORP. |
K031813 |
06/12/2003 |
OSSATURA DENTAL |
ISOTIS NV |
K001780 |
06/13/2000 |
COPAN VIRAL TRANSYSTEM |
COPAN DIAGNOSTICS, INC. |
K051661 |
06/22/2005 |
IMPLANT HANDPIECES |
SIRONA DENTAL SYSTEMS GMBH |
K051709 |
06/27/2005 |
HIPPOCAMPE WHEELCHAIR |
VIPAMAT TECHNOLOGIE |
K001971 |
06/28/2000 |
HEMODIALYSIS TUBING SETS |
OFI BIOMEDICA S.P.A. |
K121898 |
06/29/2012 |
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE |
QUICK-MED TECHNOLOGIES, INC. |
K061862 |
06/30/2006 |
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM |
AXIOM ORTHOPAEDICS, INC. |
K022119 |
07/01/2002 |
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE |
ELECTRO MEDICAL SYSTEMS SA |
K982327 |
07/02/1998 |
INFRAMETRICS INFRACAM-MED |
INFRAMETRICS, INC. |
K002013 |
07/03/2000 |
OMNIPORT |
ADVANCED SURGICAL CONCEPTS (ASC) |
K032093 |
07/07/2003 |
PARIEFIX |
SOFRADIM PRODUCTION |
K992363 |
07/15/1999 |
SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN |
EUROMED, INC. |
K041920 |
07/16/2004 |
INFINITY PLUS ELECTROTHERAPY SYSTEM |
EMPI |
K082019 |
07/16/2008 |
FREEDOM TOTAL KNEE SYSTEM |
MAXX ORTHOPEDICS, INC. |
K032283 |
07/24/2003 |
DESIGNS FOR VISION FIBEROPTIC LIGHT |
DESIGNS FOR VISION, INC. |
K042057 |
07/30/2004 |
INFINITY ELECTROTHERAPY SYSTEM |
EMPI |
K072123 |
08/02/2007 |
HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE |
BIOWAVE CORPORATION |
K992635 |
08/06/1999 |
INTERFACE MODULE IDDD |
STOECKERT INSTRUMENTE |
K012746 |
08/16/2001 |
ICE BATON |
BEHIVE LTD |
K032543 |
08/18/2003 |
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES |
SIRONA DENTAL SYSTEMS GMBH |
K222519 |
08/19/2022 |
ClearPoint System |
ClearPoint Neuro, Inc. |
K072357 |
08/22/2007 |
NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM |
AFP IMAGING CORP. |
K052289 |
08/23/2005 |
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE |
BIOWAVE CORPORATION |
K982994 |
08/27/1998 |
SKULL BASE INSTATRAK SYSTEM |
VISUALIZATION TECHNOLOGY, INC. |
K032654 |
08/28/2003 |
PORT CASSETTE |
OREX COMPUTED RADIOGRAPHY LTD |
K002699 |
08/30/2000 |
PARIETEX COMPOSITE (PCO) MESH |
MEDICAL DEVICE CONSULTANTS, INC. |
K012949 |
09/04/2001 |
URETEX SUP PUBOURETHRAL SLING |
SOFRADIM PRODUCTION |
K983144 |
09/08/1998 |
FLEXPOSURE RETRACTOR |
ENDIUS, INC. |
K032776 |
09/08/2003 |
VACURECT VACUUM CONSTRICTION DEVICE |
VACURECT MANUFACTURING (PTY) LTD. |
K052515 |
09/14/2005 |
SIROENDO |
SIRONA DENTAL SYSTEMS GMBH |
K983249 |
09/16/1998 |
SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN |
EUROMED, INC. |
K993161 |
09/22/1999 |
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM |
COPAN DIAGNOSTICS, INC. |
K013176 |
09/24/2001 |
MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE |
AFP IMAGING CORP. |
K983529 |
10/08/1998 |
INSTATRAK 3000 |
VISUALIZATION TECHNOLOGY, INC. |
K093188 |
10/09/2009 |
AFM ULTRA AG DRESSINGS |
MILLIKEN & CO. |
K983567 |
10/13/1998 |
IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM |
MED IMAGES, INC. |
K964111 |
10/15/1996 |
LITHOVAC SUCTION/ASPIRATION PROBE |
ELECTRO MEDICAL SYSTEMS SA |
K993535 |
10/19/1999 |
METAPAK MULTI-PURPOSE INSTRUMENT TRAY |
RILEY MEDICAL, INC. |
K072956 |
10/19/2007 |
MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY |
DERMA SCIENCES, INC. |
K013499 |
10/22/2001 |
DIOMED 15 PLUS AND DIOMED 30PLUS LASERS |
DIOMED, INC. |
K033376 |
10/22/2003 |
UGYTEX MESH |
SOFRADIM PRODUCTION |
K043055 |
11/05/2004 |
TERRAQUANT MQ2000 LASER THERAPY DEVICE |
ESCADA INTERNATIONAL, INC. |
K073170 |
11/09/2007 |
R-PORT II LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
K974297 |
11/17/1997 |
GALILEO DISPOSABLE HYSTEROSCOPES |
NETOPTIX CORP. |
K033640 |
11/20/2003 |
SIROSON L AND SIROSONIC L ULTRASONIC SCALERS |
SIRONA DENTAL SYSTEMS GMBH |
K033675 |
11/24/2003 |
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER |
SIRONA DENTAL SYSTEMS GMBH |
K033812 |
12/09/2003 |
SIROAIR L AIR SCALER |
SIRONA DENTAL SYSTEMS GMBH |
K083659 |
12/10/2008 |
SILVER WOUND PAD |
MILLIKEN & CO. |
K974619 |
12/11/1997 |
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM |
AFP IMAGING CORP. |
K043530 |
12/21/2004 |
DVI CURING LIGHT |
DESIGNS FOR VISION, INC. |
K003990 |
12/26/2000 |
SOFRADIM PARIETEX SURGICAL MESHES |
SOFRADIM PRODUCTION |
K073719 |
12/31/2007 |
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
K970352 |
01/30/1997 |
SMARTVAC SMOKE EVACUATION SYSTEM |
ISOMEDIX OPERATIONS INC. |
K040998 |
04/19/2004 |
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH |
SOFRADIM PRODUCTION |
K981828 |
05/22/1998 |
GALILEO DISPOSABLE HYSTEROSCOPES |
NETOPTIX CORP. |
K962116 |
05/31/1996 |
GALILEO ENDOSCOPES |
GALILEO ELECTRO-OPTICS CORP. |
K960095 |
01/11/1996 |
BACTIDROP CALCOFLUOR WHITE |
REMEL CO. |
K111860 |
06/30/2011 |
BD MAX GBS ASSAY, BD MAX INSTRUMENT |
BECTON DICKINSON & CO. |
K070858 |
03/28/2007 |
EXPRESS SERIES |
MEDICAL GRAPHICS CORP. |
K121767 |
06/15/2012 |
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE |
MEDTRONIC INC. |
K122827 |
09/14/2012 |
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 |
MEDTRONIC INC. |
K122913 |
09/21/2012 |
AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 |
MEDTRONIC INC. |
K093203 |
10/13/2009 |
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 |
MEDTRONIC INC. |
K123314 |
10/25/2012 |
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE |
MEDTRONIC INC. |
K170951 |
03/31/2017 |
CardioCel 3D |
Admedus Regen Pty Ltd |
K162579 |
09/15/2016 |
VascuCel |
Admedus Regen Pty Ltd |
K980806 |
03/03/1998 |
AFFINITY MEDICAL PATIENT CABLE SYSTEM |
AFFINITY MEDICAL TECHNOLOGIES, LLC. |
K991400 |
04/22/1999 |
PARIETENE POLYPROPYLENE MESH |
SOFRADIM PRODUCTION |
K991416 |
04/23/1999 |
ENDOSCOPIC CAMERA |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
K993544 |
10/19/1999 |
SPACE-OR RETRACTOR |
ADVANCED SURGICAL CONCEPTS (ASC) |
K970399 |
02/03/1997 |
KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) |
ALLEGIANCE HEALTHCARE CORP. |
K961154 |
03/22/1996 |
BAXTER SODIUM ACETATE INFANT HEEL WARMER |
BAXTER HEALTHCARE CORP. |
K971381 |
04/14/1997 |
POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
K962022 |
05/23/1996 |
POWERCUT GOLD SURGICAL SYSTEM |
BAXTER HEALTHCARE CORP. |
K972291 |
06/19/1997 |
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
K964029 |
10/07/1996 |
EMERGENCY RELIEF KIT SYSTEM |
BAXTER HEALTHCARE CORP. |
K222418 |
08/10/2022 |
Nuvola |
Gruppo Europeo Ortodonzia srl |
K211163 |
04/19/2021 |
Bone Cement Genta, Bone Cement HV, Bone Cement LV |
Tecres S.p.A. |
K181732 |
07/02/2018 |
InterSpace Knee Extra-Large Size, InterSpace Knee ATS |
Tecres SpA |
K133013 |
09/25/2013 |
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE |
INVENTIS SRL |
K180592 |
03/06/2018 |
G-scan Brio |
Esaote S.p.A |
K161359 |
05/16/2016 |
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System |
Esaote S.p.A |
K162290 |
08/15/2016 |
MyLabSix CrystaLine |
ESAOTE S.P.A. |
K173291 |
10/16/2017 |
6440 Ultrasound System |
Esaote S.p.A |
K163082 |
11/03/2016 |
6200 Ultrasound System and 6250 Ultrasound System |
ESAOTE S.P.A |
K183191 |
11/19/2018 |
6420 Ultrasound System |
Esaote, S.p.A. |
K183685 |
12/28/2018 |
O-Scan |
Esaote S.p.A |
K220131 |
01/18/2022 |
KYPHON VuE Bone Cement |
Tecres S.p.A. |
K172010 |
07/03/2017 |
gel-e Bandage |
gel-e, Inc. (formerly Remedium Technologies, Inc.) |
K962649 |
07/08/1996 |
SPORTROL RAPID STERILITY INDICATOR |
NORTH AMERICAN SCIENCE ASSOC., INC. |
K983451 |
09/30/1998 |
CHALLENGE TEST PACK |
NORTH AMERICAN SCIENCE ASSOC., INC. |
K221859 |
06/27/2022 |
Atalante |
Wandercraft SAS |
K130297 |
02/06/2013 |
SCANORA 3DX |
PALODEX GROUP OY |
K110839 |
03/25/2011 |
SCANORA 3D |
SOREDEX PALODEX GROUP OY |
K122018 |
07/10/2012 |
OP300 |
PALODEX GROUP OY |
K163343 |
11/29/2016 |
Icare HOME tonometer |
Icare Finland Oy |
K093683 |
11/30/2009 |
ORTHOPANTOMOGRAPH OP300 |
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY |
K153694 |
12/23/2015 |
Icare ic100 |
Icare Finland Oy |
K231408 |
05/15/2023 |
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile |
Shandong Intco Medical Products Co, Ltd. |
K202708 |
09/16/2020 |
Surgical Face Masks |
Intco Medical(HK) Co., Ltd. |
K000976 |
03/27/2000 |
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) |
INSTRUMENTARIUM IMAGING, INC. |
K001171 |
04/11/2000 |
DELTA 16 TACT |
INSTRUMENTARIUM IMAGING, INC. |
K981641 |
05/08/1998 |
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ |
INSTRUMENTARIUM CORP. |
K223180 |
10/11/2022 |
AIRAscore |
AIRAmed GmbH |
K223254 |
10/21/2022 |
C2 Xplore |
Inomed Medizintechnik GmbH |
K103555 |
12/03/2010 |
MULTIPLATE 5.0 AGGREGOMETER |
VERUM DIAGNOSTICA GMBH |
K150235 |
02/02/2015 |
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels |
BOSTON SCIENTIFIC CORPORATION |
K180734 |
03/20/2018 |
SmartLinx Vitals Plus Patient Monitoring System |
Capsule Technologie |
K152693 |
09/21/2015 |
CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels |
BOSTON SCIENTIFIC CORPORATION |
K133566 |
11/20/2013 |
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS |
BOSTON SCIENTIFIC CORP. |
K183638 |
12/26/2018 |
SmartLinx Vitals Plus Patient Monitoring System |
Capsule Technologie |