| K221537 |
05/27/2022 |
Nightwear Aligners |
Smylio Inc. |
| K212660 |
08/23/2021 |
Smylio Invisible Clear Aligners |
Smylio, Inc |
| K160081 |
01/15/2016 |
TENS Electrodes |
CATHAY MANUFACTURING CORP. |
| K170369 |
02/06/2017 |
Disposable Electrosurgical Pencils |
Cathay Manfacturing Corp. |
| K120554 |
02/23/2012 |
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K230566 |
03/01/2023 |
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor |
Joytech Healthcare Co.,Ltd |
| K150545 |
03/03/2015 |
Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K170666 |
03/06/2017 |
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors |
Joytech Healthcare Co., Ltd. |
| K200599 |
03/09/2020 |
Digital Thermometer |
Joytech Healthcare Co., Ltd |
| K200649 |
03/12/2020 |
Arm-Type Fully Automatic Digital Blood Pressure Monitor |
Joytech Healthcare Co., Ltd |
| K110776 |
03/21/2011 |
DIGITAL THERMOMETER MT SERIES |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K190873 |
04/03/2019 |
Infrared Ear/Forehead Thermometer |
Joytech Healthcare Co., Ltd. |
| K190886 |
04/04/2019 |
Non-invasive blood pressure measurement systems |
Joytech Healthcare Co., Ltd |
| K181081 |
04/24/2018 |
Infrared Ear Thermometer |
Joytech Healthcare Co., Ltd. |
| K121355 |
05/04/2012 |
WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K181239 |
05/10/2018 |
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer |
Joytech Healthcare Co.,Ltd |
| K161577 |
06/07/2016 |
Arm-Type Fully Automatic Digital Blood Pressure Monitor |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K141755 |
06/30/2014 |
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K212115 |
07/07/2021 |
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor |
JOYTECH HEALTHCARE CO.,LTD |
| K082192 |
08/04/2008 |
INFRARED EAR THERMOMETER, MODEL ET-101A |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K152426 |
08/26/2015 |
Wrist - Type Fully Automatic Digital Blood Pressure Monitor |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K152687 |
09/18/2015 |
Arm-Type Fully Automatic Digital Blood Pressure Monitor |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K182629 |
09/24/2018 |
Digital Thermometer |
Joytech Healthcare Co., Ltd. |
| K172989 |
09/27/2017 |
Electric Breast Pump |
Joytech Healthcare Co., Ltd. |
| K173024 |
09/28/2017 |
Non-invasive blood pressure measurement systems |
Joytech Healthcare Co.,Ltd |
| K153149 |
10/30/2015 |
Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K153146 |
10/30/2015 |
Infrared Ear Thermometer |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K183393 |
12/07/2018 |
Digital Thermometer |
Joytech Healthcare Co.,Ltd |
| K163518 |
12/15/2016 |
Digital Thermometer |
JOYTECH HEALTHCARE CO., LTD |
| K113598 |
12/05/2011 |
POWER-LOAD COT FASTENER SYSTEM |
STRYKER MEDICAL |
| K131816 |
06/20/2013 |
SORIN CONNECT DATA MANAGEMENT SYSTEM |
SORIN GROUP DEUTSCHLAND GMBH |
| K200586 |
03/06/2020 |
Straumann TLX Implant System |
Institut Straumann AG |
| K030009 |
01/02/2003 |
KSEA POWERSHAVER SYSTEM S2 |
KARL STORZ ENDOSCOPY |
| K960486 |
02/02/1996 |
KSEA MODEL 383320 20 ANGIOMAT |
KARL STORZ ENDOSCOPY |
| K140312 |
02/07/2014 |
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM |
EDWARDS LIFESCIENCES, LLC. |
| K040476 |
02/24/2004 |
STORZ MODULITH, MODEL SLX-F2 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K960791 |
02/27/1996 |
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K961091 |
03/19/1996 |
KARL STORZ MODEL 203020 20 EQUIMAT |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K961178 |
03/26/1996 |
KARL STORZ INTUBATION FIBERSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K961713 |
05/02/1996 |
INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K962030 |
05/24/1996 |
KARL STORZ REMORGIDA FORCEPS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K962090 |
05/29/1996 |
KARL STORZ MODEL 203210 O1 UNIMAT PLUS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K962083 |
05/29/1996 |
KARL STORZ REMORGIDA FORCEPS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
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08/08/2008 |
LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE |
INTEGRATED MEDICAL SYSTEMS, INC. |
| K954797 |
10/18/1995 |
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K955756 |
12/19/1995 |
KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K970055 |
01/07/1997 |
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K960323 |
01/23/1996 |
KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
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02/23/1996 |
KARL STORZ URETER RESECTOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K171996 |
07/03/2017 |
TruWave Disposable Pressure Transducer |
Edwards Lifesciences, LLC |
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07/23/1996 |
KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K102922 |
10/01/2010 |
HARDYCHROM MRSA |
HARDY DIAGNOSTICS |
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02/01/2017 |
SunCHECK |
SUN NUCLEAR CORPORATION |
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02/09/2005 |
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE |
TECHNOMED EUROPE |
| K062437 |
08/11/2006 |
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED |
TECHNOMED EUROPE |
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09/01/2004 |
SMK, CX, CXE, RCN |
TECHNOMED EUROPE |
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05/12/1998 |
STRATA, MODEL V.O.95 |
ROSSES MEDICAL SYSTEMS |
| K191179 |
05/02/2019 |
Myo Plus |
Otto Bock Healthcare Products GmbH |
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07/07/2014 |
MYGAIT STIMULATION SYSTEM |
OTTO BOCK HEALTHCARE PRODUCTS GMBH |
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10/22/2004 |
STAT MEDICAL PEN NEEDLE |
EMERGO GROUP, INC. |
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01/23/2003 |
F1 DIODE LASER SYSTEM |
OPUS MEDICAL, INC. |
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07/15/2016 |
DoseCHECK |
Sun Nuclear Corporation |
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07/07/2003 |
SMART KLAMP VARIOUS BY SIZE |
EMERGO GROUP, INC. |
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09/07/2004 |
MODIFIED SPACEMAKER SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
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06/14/2007 |
PARIETEX POLYESTER MESH WITH INTRODUCER |
SOFRADIM PRODUCTION |
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09/12/2008 |
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP |
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10/04/2012 |
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE |
COVIDIEN |
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05/03/2017 |
Tubing Pack |
Medtronic, Inc. |
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06/30/2017 |
Tubing Pack |
Medtronic, Inc. |
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07/21/2016 |
Affinity NT Oxygenator with Cortiva BioActive Surface |
MEDTRONIC, INC. |
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10/17/2016 |
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface |
MEDTRONIC, INC. |
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04/02/2001 |
A-LINE AEP MONITOR |
ALARIS MEDICAL SYSTEMS, INC. |
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06/21/2004 |
BIS PEDIATRIC SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
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07/25/2013 |
ERGONOMIC PRODUCTS WORKSTATION |
ERGONOMIC PRODUCTS, INC. |
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09/11/2006 |
BIS BILATERAL SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
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06/04/2012 |
MINIARC PRO SINGLE-INCISION SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS |
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06/19/2012 |
AMS LARGE PORE POLYPROPHLENE MESH |
AMERICAN MEDICAL SYSTEMS |
| K132655 |
08/26/2013 |
RETROARC RETROPUBIC SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
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09/30/2013 |
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM |
Boston Scientific Corporation |
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03/07/2016 |
XYcor« Expandable Spinal Spacer System |
Alphatec Spine, Inc |
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05/17/2016 |
Arsenal Spinal Fixation System |
ALPHATEC SPINE, INC |
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10/08/2015 |
Arsenal Spinal Fixation System |
ALPHATEC SPINE, INC |
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11/03/2014 |
Arsenal Spinal Fixation System |
ALPHATEC SPINE, INC. |
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12/17/2015 |
Alphatec Navigation Instruments |
ALPHATEC SPINE, INC. |
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04/30/2021 |
CAPRI Corpectomy Cage System |
K2M, Inc. |
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05/23/2022 |
Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement Syste |
Stryker Spine |
| K183071 |
11/05/2018 |
VLIFT-s Vertebral Body Replacement System |
Stryker Spine |
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04/29/2009 |
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS |
ETHICON ENDO-SURGERY, INC. |
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09/13/2010 |
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER |
ETHICON ENDO-SURGERY, INC. |
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10/15/2009 |
ETHICON ENDO-SURGERYOPTICAL DILATOR |
ETHICON ENDO-SURGERY, INC. |
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02/14/2022 |
Tornier Perform Humeral System û Stemless |
Tornier, Inc. |
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03/30/2022 |
Tornier Perform Humeral System û Fracture |
Tornier, Inc. |
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04/04/2017 |
Latitude EV Total Elbow Arthroplasty |
Tornier Inc. |
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05/18/2020 |
PERFORM Humeral System û Stem |
Tornier, Inc. |
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06/15/2018 |
ORTHOLOC SPS Shoulder Plating System |
Tornier Inc. |
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06/26/2019 |
ORTHOLOCÖ SPS Shoulder Plating System |
Tornier Inc. |
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09/10/2018 |
LATITUDE EV Total Elbow Arthroplasty |
Tornier Inc. |
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11/25/2019 |
LATITUDE EVÖ Total Elbow Arthroplasty |
Tornier Inc. |
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01/19/2016 |
Heat Pain Pro |
OMRON HEALTHCARE, INC. |
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03/18/2019 |
HEM-6410T-ZL Wrist Blood Pressure Monitor |
Omron Healthcare, Inc. |
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07/10/2017 |
Avail |
Omron Healthcare, Inc. |
| K181992 |
07/26/2018 |
Heat Pain Pro |
Omron Healthcare, Inc. |
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07/28/2016 |
Evolv Model BP7000 Upper Arm Blood Pressure Monitor |
OMRON HEALTHCARE, INC. |
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08/06/2018 |
Wrist Blood Pressure Monitor Model BP6100 |
Omron Healthcare, Inc. |
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08/06/2018 |
Maxpower Relief |
Omron Healthcare, Inc. |
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08/07/2020 |
Omron Model BP7900 Blood Pressure Monitor + EKG |
Omron Healthcare, Inc. |
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08/10/2018 |
Wrist Blood Pressure Monitor Model BP4350 |
Omron Healthcare, Inc. |
| K182481 |
09/10/2018 |
HEM-6410T-ZM Wrist Blood Pressure Monitor |
Omron Healthcare, Inc. |
| K182579 |
09/19/2018 |
Omron Model BP7900 Blood Pressure Monitor + EKG |
Omron Healthcare, Inc. |
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10/07/2014 |
BP652N (HEM-6300-Z) |
OMRON Healthcare, Inc |
| K163045 |
10/31/2016 |
Omron HEM-6400T-Z Wrist Blood Pressure Monitor |
Omron Healthcare, Inc. |
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11/17/2016 |
HEM-9210T |
Omron Healthcare, Inc. |
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11/19/2018 |
Focus TENS Therapy, Model PM710-M/-L |
Omron Healthcare, Inc. |
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03/20/2017 |
EchoPAC Software Only, EchoPAC Plug-in |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
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09/05/2018 |
Centricity Universal Viewer |
GE Healthcare |
| K211823 |
06/14/2021 |
Bonine Acupressure Bands |
WellSpring Pharmaceutical Corporation |
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04/07/1998 |
PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA |
HEWLETT-PACKARD CO. |
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07/06/1998 |
NC-STAT |
NEUROMETRIX, INC. |
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07/20/1999 |
PROTON BEAM THERAPY SYSTEM (PBTS) |
OPTIVUS TECHNOLOGY, INC. |
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02/10/1997 |
SMARTSITE ACCESS PIN |
IVAC MEDICAL SYSTEMS |
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02/11/2003 |
MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) |
ALARIS MEDICAL SYSTEMS, INC. |
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04/02/2001 |
MEDLEY SP02 MODULE, MODEL 8220 |
ALARIS MEDICAL SYSTEMS, INC. |
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04/15/1996 |
IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT |
IVAC MEDICAL SYSTEMS |
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06/04/2003 |
MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 |
ALARIS MEDICAL SYSTEMS, INC. |
| K012383 |
07/27/2001 |
GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C |
ALARIS MEDICAL SYSTEMS, INC. |
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08/12/2002 |
MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE |
ALARIS MEDICAL SYSTEMS, INC. |
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09/17/2001 |
SINGLE DOSE DISPENSING PIN, MODEL 2201 |
ALARIS MEDICAL SYSTEMS, INC. |
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09/30/2002 |
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 |
ALARIS MEDICAL SYSTEMS, INC. |
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10/18/1999 |
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS |
ALARIS MEDICAL SYSTEMS, INC. |
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11/18/1997 |
VARIABLE PRESSURE SYRINGE PUMP |
ALARIS MEDICAL SYSTEMS, INC. |
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10/18/2013 |
ARSENAL SPINAL FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
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12/11/2007 |
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 |
ETHICON ENDO-SURGERY, INC. |
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06/15/2022 |
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) |
Smith and Nephew, Inc. |
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04/13/2005 |
RT019 INSPIRATORY/EXPIRATORY FILTER |
FISHER & PAYKEL HEALTHCARE, LTD. |
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06/20/2016 |
LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer |
AAP IMPLANTATE AG |
| K161696 |
06/20/2016 |
aap LOQTEQ« Distal Lateral Humerus Plate 2.7/3.5 |
AAP IMPLANTATE AG |
| K161747 |
06/24/2016 |
LOQTEQ« VA Distal Tibia Plate System: LOQTEQ« VA Distal Medial Tibia Plate 3.5; LOQTEQ« VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ« VA Distal Fibula Plate 2.7/3.5 |
aap Implantate AG |
| DEN230012 |
02/16/2023 |
Ruthless Spine RJB |
Ruthless, LLC dba Ruthless Spine |
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06/20/2018 |
Endoscopic Linear Cutting Staplers and Loading Units for Single Use |
Ezisurg (Suzhou) Medical Co., Ltd. |
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07/08/2002 |
ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS |
ALARIS MEDICAL SYSTEMS, INC. |
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03/16/2022 |
RobPath« Total Hip Application |
Hangzhou Lancet Robotics Co., Ltd. |
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01/23/2004 |
PERIPHERAL CUTTING BALLOON |
BOSTON SCIENTIFIC CORP. |
| K051254 |
05/16/2005 |
PERIPHERAL CUTTING BALLOON |
BOSTON SCIENTIFIC IVT |
| K041993 |
07/23/2004 |
2 CM PERIPHERAL CUTTING BALOON |
BOSTON SCIENTIFIC IVT |
| K052038 |
07/28/2005 |
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM |
Boston Scientific Corporation |
| K220697 |
03/09/2022 |
Nitrile Patient Examination Gloves, Powder Free |
Lalan Rubbers (Pvt) Ltd |
