| K160173 |
01/27/2016 |
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) |
Boston Scientific Corporation |
| K160514 |
02/24/2016 |
OptiCross 18, 30 MHz Peripheral Imaging Catheter |
BOSTON SCIENTIFIC CORPORATION |
| K161125 |
04/21/2016 |
OptiCross X, 40 MHz Coronary Imaging Catheter |
Boston Scientific Corporation |
| K171268 |
05/01/2017 |
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter |
MicroTherapeutics, Inc. d/b/a ev3 Neurovascular |
| K111498 |
05/31/2011 |
FATHOM (TM) 14 STEERABLE GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
| K111485 |
05/31/2011 |
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX |
Boston Scientific Corporation |
| K192460 |
09/09/2019 |
Sentinel Cerebral Protection System |
Boston Scientific Corporation |
| K123621 |
11/23/2012 |
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER |
BOSTON SCIENTIFIC CORP. |
| K153617 |
12/18/2015 |
OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) |
BOSTON SCIENTIFIC CORPORATION |
| K211590 |
05/24/2021 |
Fiducial Marker |
Carbon Medical Technologies Inc. |
| K191797 |
07/03/2019 |
BiomarC Fiducial Marker |
Carbon Medical Technologies |
| K160112 |
01/19/2016 |
Besmed PEEP Valve |
BESMED HEALTH BUSINESS CORP. |
| K210143 |
01/19/2021 |
Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) |
Foshan Nanhai Plus Medical CO LTD |
| K211036 |
04/07/2021 |
Plus Medical Chemotherapy Gown |
Foshan Nanhai Plus Medical CO LTD |
| K212600 |
08/17/2021 |
Disposable Medical Nitrile Examination Gloves (Non-sterile) |
Suqian Linglian Medical Technology Co., Ltd |
| K222480 |
08/17/2022 |
Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) |
Foshan Nanhai Plus Medical Co., Ltd. |
| K212698 |
08/25/2021 |
Plus Medical Isolation Gown Level 3 |
Foshan Nanhai Plus Medical Co Ltd |
| K213177 |
09/28/2021 |
Plus Medical Cover Gown |
Foshan Nanhai Plus Medical CO LTD |
| K050951 |
04/15/2005 |
MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 |
CIBERNET SYSTEMS CORP. |
| K151211 |
05/06/2015 |
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup |
Assure Tech. Co., Ltd |
| K152025 |
07/22/2015 |
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
ASSURE TECH. CO., LTD. |
| K152768 |
09/24/2015 |
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip |
ASSURE TECH. CO., LTD. |
| K210402 |
02/10/2021 |
Curiteva Sacroiliac Joint Fusion System |
Curiteva, Inc. |
| K231232 |
04/28/2023 |
Curiteva Laminoplasty System |
Curiteva, Inc. |
| K181261 |
05/11/2018 |
Curiteva Cervical Interbody Fusion System |
Curiteva, LLC |
| K181549 |
06/12/2018 |
Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) |
Curiteva, LLC |
| K181562 |
06/14/2018 |
Curiteva Anterior Cervical Plate System |
Curiteva, LLC |
| K181589 |
06/18/2018 |
Curiteva Lumbar Interbody Fusion System |
Curiteva, LLC |
| K191810 |
07/05/2019 |
Curiteva Pedicle Screw System |
Curiteva, Inc. |
| K213030 |
09/21/2021 |
Curiteva Porous PEEK Cervical Interbody Fusion System |
Curiteva, Inc. |
| K223200 |
10/13/2022 |
Curiteva Navigation System |
Curiteva, Inc. |
| K992916 |
08/30/1999 |
BRAINLAB STEREOTACTIC ARC |
BRAINLAB |
| K983660 |
10/19/1998 |
EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) |
BRAINLAB, INC. |
| K190365 |
02/15/2019 |
Baby Gorilla/Gorilla Plating System |
Paragon 28, Inc. |
| K190586 |
03/06/2019 |
Monster« Screw System |
Paragon 28, Inc. |
| K191227 |
05/07/2019 |
Paratrooper Plantar Plate Repair System |
Paragon 28, Inc. |
| K191782 |
07/02/2019 |
TTC Phantom Intramedullary Nail System |
Paragon 28, Inc. |
| K182148 |
08/08/2018 |
SILVERBACK Gorilla Plating System |
Paragon 28, Inc. |
| K182307 |
08/24/2018 |
Small Bone Phantom« Intramedullary Nail System; TTC Phantom« Intramedullary Nail System |
Paragon 28, Inc |
| K172886 |
09/21/2017 |
Breakaway Screw System |
Paragon 28 |
| K182898 |
10/16/2018 |
TenoTac Soft Tissue Fixation System |
Paragon 28, Inc |
| K192994 |
10/25/2019 |
Paragon 28 APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. |
| K133475 |
11/12/2013 |
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS |
NEXXT SPINE LLC |
| K183228 |
11/20/2018 |
HammerToe Compression System |
Paragon 28, Inc. |
| K183690 |
12/31/2018 |
Tenodesis Screw System |
Paragon 28,Inc. |
| K070239 |
01/25/2007 |
MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM |
EXIR PHARMACEUTICAL CO. |
| K070472 |
02/20/2007 |
CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230 |
TaiDoc Technology Corporation |
| K070641 |
03/08/2007 |
ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 |
TaiDoc Technology Corporation |
| K070941 |
04/04/2007 |
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 |
TaiDoc Technology Corporation |
| K091555 |
05/27/2009 |
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
| K071493 |
05/30/2007 |
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225 |
TaiDoc Technology Corporation |
| K091814 |
06/18/2009 |
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE |
TaiDoc Technology Corporation |
| K091898 |
06/24/2009 |
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234 |
TaiDoc Technology Corporation |
| K091897 |
06/24/2009 |
BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019 |
TaiDoc Technology Corporation |
| K092106 |
07/14/2009 |
U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132 |
TaiDoc Technology Corporation |
| K072039 |
07/25/2007 |
ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F |
TaiDoc Technology Corporation |
| K132338 |
07/26/2013 |
DA01 BLOOD GLUCOSE MONITORING SYSTEM |
DELBIO INCORPORATION |
| K072489 |
09/04/2007 |
REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
| K133090 |
09/30/2013 |
OXICARE FINGERTIP PULSE OXIMETER |
DELBIO INCORPORATION |
| K072784 |
10/01/2007 |
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
| K073119 |
11/05/2007 |
CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
| K073118 |
11/05/2007 |
PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM |
DIAGNOSTIC DEVICES INC. |
| K073445 |
12/07/2007 |
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 |
TaiDoc Technology Corporation |
| K161302 |
05/09/2016 |
PC ECG |
EDAN INSTRUMENTS, INC. |
| K161300 |
05/09/2016 |
Acclarix AX8 Diagnostic Ultrasound System |
EDAN INSTRUMENTS INC. |
