K120840 |
03/20/2012 |
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM |
L&K BIOMED CO., LTD |
K120879 |
03/23/2012 |
LEXUS CERVICAL FIXATION SYSTEM |
L & K BIOMED CO., LTD |
K121096 |
04/11/2012 |
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM |
L & K BIOMED CO., LTD |
K143271 |
11/13/2014 |
CastleLoc-P Anterior Cervical Plate System |
L&K BIOMED Co., Ltd |
K143279 |
11/14/2014 |
LnK Anterior Cervical Plate System |
L&K BIOMED Co., Ltd. |
K143363 |
11/24/2014 |
VENUS Spinal Fixation System |
L&K BIOMED Co., Ltd. |
K200793 |
03/26/2020 |
LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System |
L&K BIOMED Co., Ltd. |
K200789 |
03/26/2020 |
LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System |
L&K BIOMED Co., Ltd. |
K200794 |
03/26/2020 |
AccelFix Spinal Fixation System |
L&K BIOMED Co., Ltd. |
K200790 |
03/26/2020 |
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System |
L&K BIOMED Co., Ltd. |
K221050 |
04/11/2022 |
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System |
Aegis Spine, Inc. |
K221719 |
06/13/2022 |
ABTross ALIF Expandable Cage System |
Aegis Spine, Inc. |
K192481 |
09/10/2019 |
AccelFix Lumbar Plate System |
L&K Biomed Co., Ltd. |
K223521 |
11/23/2022 |
ZESPIN SI Joint Fusion System |
Aegis Spine, Inc. |
K223719 |
12/12/2022 |
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System |
Aegis Spine, Inc. |
K060179 |
01/23/2006 |
BIO-RAY SDX DIGITAL X-RAY SYSTEM |
SIGMA BIOMEDICS, INC. |
K103600 |
12/08/2010 |
PORTABLE X-RAY SYSTEM |
DIGIMED CORPORATION |
K970376 |
02/03/1997 |
PTCA GUIDEWIRE |
LAKE REGION MFG., INC. |
K970994 |
03/19/1997 |
CORE AND COIL ASSEMBLY GUIDEWIRE |
LAKE REGION MFG., INC. |
K971322 |
04/10/1997 |
CORE AND COIL ASSEMBLY GUIDEWIRE |
LAKE REGION MFG., INC. |
K031891 |
06/13/2003 |
VIRTUOSAPH |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
DEN070014 |
06/20/2007 |
MANDOMETER III |
AB MANDO |
K083693 |
12/12/2008 |
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. |
K063698 |
12/13/2006 |
CO2 LASER SYSTEM, MODEL C-LAS |
CLINICON CORP. |
K222297 |
08/01/2022 |
CentriMag Pre-connected Pack |
Abbott |
K181852 |
07/11/2018 |
Percuvance Percutaneous Surgical System |
Teleflex Medical, Inc. |
K142492 |
09/04/2014 |
GM60A-32S, GM60A-40S |
SAMSUNG ELECTRONICS CO., LTD. |
K143029 |
10/21/2014 |
Digital Diagnostic X-ray System (GC80) |
SAMSUNG ELECTRONICS CO., LTD. |
K150550 |
03/03/2015 |
SilverCoat Silicone Foley Catheter |
COVALON TECHNOLOGIES, INC. |
K112549 |
09/01/2011 |
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER |
COVALON TECHNOLOGIES, INC. |
K163556 |
12/19/2016 |
MediClear PreOp |
COVALON TECHNOLOGIES, INC. |
K113323 |
11/10/2011 |
ARTUS INFL A/B RG RT-PCR KIT |
QIAGEN, GMBH |
K161829 |
07/05/2016 |
Huvitz Imaging System |
HUVITZ CO., LTD. |
K220024 |
01/05/2022 |
ChoiceSpine Navigation System |
ChoiceSpine, LLC |
K140142 |
01/22/2014 |
CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) |
CHOICE SPINE, LP |
K190227 |
02/05/2019 |
BoomerangÖ Anterior Cervical Plate System |
ChoiceSpine, LP |
K180519 |
02/27/2018 |
HARRIER-SAÖ Lumbar Interbody System |
Choice Spine, LP |
K170821 |
03/20/2017 |
ChoiceSpineÖ Proliant« Posterior Pedicle Screw and Hook Fixation System |
Choice Spine, LP |
K160775 |
03/21/2016 |
ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
CHOICE SPINE LP |
K170942 |
03/30/2017 |
The ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
Choice Spine, LP |
K170953 |
03/31/2017 |
Tomcat Cervical Spinal System |
Choice Spine, LP |
K220953 |
04/01/2022 |
ChoiceSpine TigerSharkÖ M, Modular Interbody System |
ChoiceSpine, LLC |
K211449 |
05/10/2021 |
TritonÖ Sacroiliac Joint Fixation System |
ChoiceSpine, LLC |
K171456 |
05/17/2017 |
ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
Choice Spine |
K171489 |
05/22/2017 |
Acapella Cervical Spacer System |
Choice Spine, LP. |
K191367 |
05/22/2019 |
Harrier-SA Lumbar Interbody System |
ChoiceSpine LLC |
K171686 |
06/07/2017 |
Choice Spine HawkeyeÖ Vertebral Body Replacement (VBR) System |
Choice Spine |
K201643 |
06/17/2020 |
ChoiceSpine Tiger Shark Cervical Spacer System |
ChoiceSpine, LLC |
K191621 |
06/18/2019 |
ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octan |
ChoiceSpine, LLC |
K121850 |
06/25/2012 |
Typhoon(TM) Facet Screw Fixation System |
CHOICE SPINE, LP |
K132049 |
07/02/2013 |
THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS |
CHOICE SPINE |
K162103 |
07/29/2016 |
Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine Interbody Fusion System (HarrierÖ), Choice Spine Vertebral Body Replacement System (HawkeyeÖ) |
CHOICE SPINE, LP |
K152515 |
09/02/2015 |
TOMCAT Cervical Spinal System |
CHOICE SPINE, LP |
K172816 |
09/18/2017 |
TiGer SharkÖ System |
Choice Spine, LP. |
K182721 |
09/28/2018 |
Choice Spine Navigation System |
Choice Spine, LP. |
K173215 |
10/02/2017 |
Choice Spine LaminoplastyÖ Fixation System |
Choice Spine, LP |
K133214 |
10/18/2013 |
BLACKBIRD SPINAL SYSTEM |
CHOICE SPINE, LP |
K153107 |
10/27/2015 |
Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine VEOÖ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System |
CHOICE SPINE, LP |
K203311 |
11/10/2020 |
ChoiceSpine Blackhawk Ti Cervical Spacer System |
ChoiceSpine, LLC |
K183214 |
11/19/2018 |
Raven Lumbar Plate System |
Choice Spine, LP |
K183397 |
12/07/2018 |
ChoiceSpine Stealth Cervical Spacer System |
ChoiceSpine, LP |
K203561 |
12/07/2020 |
ChoiceSpine Navigation System |
ChoiceSpine, LLC |
K183588 |
12/21/2018 |
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System |
Choice Spine |
K223869 |
12/23/2022 |
ChoiceSpine Blackhawk Ti Cervical Spacer System |
ChoiceSpine, LLC |
K120274 |
01/30/2012 |
DELTAMAXX 18 MICROCOIL SYSTEM |
CODMAN AND SHURTLEFF, INC. |
K120686 |
03/06/2012 |
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM |
Codman & Shurtleff, Inc. |
K040725 |
03/22/2004 |
BD FACSCANTO SYSTEM |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
K130981 |
04/09/2013 |
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM |
CORDIS CORP. |
K041074 |
04/26/2004 |
BD FACSCANTO WITH BD FACSANTO SOFTWARE |
BD Biosciences |
K073231 |
11/15/2007 |
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
K133843 |
12/18/2013 |
SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER |
CORDIS CORPORATION |
K200530 |
03/02/2020 |
AMICUS Separator System |
Fresenius Kabi AG |
K180615 |
03/08/2018 |
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter |
Fresenius Kabi USA LLC |
K141019 |
04/21/2014 |
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED |
FENWAL, INC. |
K111702 |
06/17/2011 |
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE |
FENWAL, INC. |
K162462 |
09/02/2016 |
AMICUS Separator System, AMICUS Separator System; Refurbished |
FRESENIUS KABI USA LLC |
K962775 |
07/16/1996 |
SUNGLASSES (NON-PRESCRIPTION) |
CANADD TRADING CO. |
K190471 |
02/26/2019 |
4CIS« Chiron Spinal Fixation System |
Solco Biomedical Co., Ltd. |
K162402 |
08/26/2016 |
4CIS« Marlin ACIF Cage System |
SOLCO BIOMEDICAL CO., LTD. |
K211114 |
04/14/2021 |
Will3D |
HDX WILL CORP. |
K181142 |
05/01/2018 |
Absoanchor Microimplant |
Dentos Inc |
K150478 |
02/24/2015 |
A35 Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD. |
K151808 |
07/02/2015 |
3D/5D Viewer |
SAMSUNG MEDISON CO., LTD |
K030301 |
01/29/2003 |
UNICONDYLAR FEMORAL COMPONENT |
SMITH & NEPHEW, INC. |
K040212 |
01/30/2004 |
TRIGEN INTERTAN |
SMITH & NEPHEW, INC. |
K040462 |
02/23/2004 |
TRIGEN TROCHANTERIC ANTEGRADE NAIL |
SMITH & NEPHEW, INC. |
K040929 |
04/09/2004 |
TRIGEN ADOLESCENT TAN |
SMITH & NEPHEW, INC. |
K041106 |
04/28/2004 |
REVISION KNEE SYSTEM |
SMITH & NEPHEW, INC. |
K021673 |
05/21/2002 |
TOTAL HIP FEMORAL HEAD - 12/14 TAPER |
SMITH & NEPHEW, INC. |
K022010 |
06/19/2002 |
TOTAL KNEE FEMORAL COMPONENT |
SMITH & NEPHEW, INC. |
K041825 |
07/07/2004 |
SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT |
SMITH & NEPHEW, INC. |
K022556 |
08/02/2002 |
REFLECTION MODIFIED ACETABULAR SHELLS |
SMITH & NEPHEW, INC. |
K022958 |
09/06/2002 |
TOTAL HIP FEMORAL HEADS AND LINERS |
SMITH & NEPHEW, INC. |
K180497 |
02/26/2018 |
Scone Mask |
ResMed Ltd |
K230322 |
02/06/2023 |
SelectFlex Neurovascular Access System Family |
Q'apel Medical, Inc. |
K111254 |
05/04/2011 |
RELIEVA SOLO ELITE SINUS BALLOON CATHETER |
ACCLARENT, INC. |
K222786 |
09/15/2022 |
072 Aspiration System |
QÆApel Medical, Inc. |
K230720 |
03/16/2023 |
LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 |
Light Tree Ventures Europe B.V. |
K221444 |
05/18/2022 |
LED Eye Perfector, model: EY-36A, EY-36B |
Light Tree Ventures Europe B.V. |
K221775 |
06/21/2022 |
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) |
Light Tree Ventures Europe B.V. |
K113287 |
11/07/2011 |
SOMATOM PERSPECTIVE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K113342 |
11/14/2011 |
SOMATOM DEFINITION FLASH |
SIEMENS MEDICAL SYSTEMS, INC. |
K001223 |
04/17/2000 |
ACULUX, MODEL AX3001, AX3002 |
ACULUX |
K013511 |
10/22/2001 |
XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) |
ACULUX, INC. |
K990011 |
01/04/1999 |
CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR |
CONTINENTAL SOFT LENS, INC. |
K152659 |
09/17/2015 |
V10 |
MEDIANA CO., LTD |
K170497 |
02/17/2017 |
V10 |
Mediana Co., Ltd. |
K230871 |
03/30/2023 |
EXTRON 5; EXTRON 7 |
DRTECH Corporation |
K213855 |
12/10/2021 |
Arrow Pressure Injectable Midline Catheter |
Arrow International LLC Subsidiary of Teleflex Incorporated |
K001179 |
04/11/2000 |
SUPER NOVA, ACUBEAM |
LIGHT FORCE THERAPY, INC. |
K160923 |
04/04/2016 |
REDAPT Anteverted Cemented Liner |
SMITH & NEPHEW, INC. |
K171073 |
04/11/2017 |
Smith & Nephew, Inc. REDAPT Augments |
Smith & Nephew, Inc. |
K162303 |
08/17/2016 |
REDAPT Sleeved Monolithic Revision Stems |
SMITH & NEPHEW INC. |
K073056 |
10/30/2007 |
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 |
VIEWORKS CO., LTD. |
K980350 |
01/28/1998 |
VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 |
CUDA PRODUCTS CO. |
K020407 |
02/06/2002 |
LORENZ BLUE DEVICE |
WALTER LORENZ SURGICAL, INC. |
K030425 |
02/10/2003 |
LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER |
WALTER LORENZ SURGICAL, INC. |
K010427 |
02/13/2001 |
LORENZ FIDUCAIL SCREW |
WALTER LORENZ SURGICAL, INC. |
K961074 |
03/18/1996 |
LIGHTSOURCE OR ILLUMINATOR |
CUDA PRODUCTS CO. |
K031034 |
04/01/2003 |
SPIN DOWN RAPIDFLAP |
WALTER LORENZ SURGICAL, INC. |
K011076 |
04/09/2001 |
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW |
WALTER LORENZ SURGICAL, INC. |
K091058 |
04/13/2009 |
ADKINS STRUT |
BIOMET MICROFIXATION, INC. |
K040983 |
04/15/2004 |
LORENZ SELF-DRILLING IMF SCREW |
WALTER LORENZ SURGICAL, INC. |
K081067 |
04/15/2008 |
FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) |
BIOMET MICROFIXATION, INC. |
K040990 |
04/16/2004 |
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS |
WALTER LORENZ SURGICAL, INC. |
K981469 |
04/23/1998 |
CERMAX300 LIGHTSOURCE |
CUDA PRODUCTS CO. |
K061384 |
05/18/2006 |
LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM |
WALTER LORENZ SURGICAL, INC. |
K031696 |
06/02/2003 |
LORENZE EXTERNAL MANDIBULAR DISTRACTOR |
WALTER LORENZ SURGICAL, INC. |
K031751 |
06/05/2003 |
RAPIDFIRE SELF DRILLING SCREWS |
WALTER LORENZ SURGICAL, INC. |
K071577 |
06/08/2007 |
BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER |
BIOMET MICROFIXATION, INC. |
K111908 |
07/05/2011 |
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM |
BIOMET MICROFIXATION, INC. |
K032228 |
07/21/2003 |
LORENZ 2.4 SELF DRILLING SCREWS |
WALTER LORENZ SURGICAL, INC. |
K042516 |
09/16/2004 |
OTOMIMIX |
WALTER LORENZ SURGICAL, INC. |
K983277 |
09/17/1998 |
LIGHTSOURCE OR ILLUMINATOR MODEL I-100 |
CUDA PRODUCTS CO. |
K062842 |
09/22/2006 |
TWIST DRILL |
WALTER LORENZ SURGICAL, INC. |
K063052 |
10/04/2006 |
LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES |
WALTER LORENZ SURGICAL, INC. |
K063386 |
11/08/2006 |
LORENZ ORTHODONTIC ANCHORAGE SYSTEM |
WALTER LORENZ SURGICAL, INC. |
K063506 |
11/20/2006 |
LORENZ STERNAL CLOSURE SYSTEM |
WALTER LORENZ SURGICAL, INC. |
K033740 |
11/28/2003 |
LORENZ STERNAL CLOSURE SYSTEM |
WALTER LORENZ SURGICAL, INC. |
K013954 |
11/30/2001 |
LORENZ SELF DRILLING SCREWS |
WALTER LORENZ SURGICAL, INC. |
K014148 |
12/18/2001 |
SELF-DRILLING RADIOGRAPHIC MARKER |
WALTER LORENZ SURGICAL, INC. |
K980166 |
01/16/1998 |
LIGHTSOURCE OR ILLUMINATOR |
CUDA PRODUCTS CO. |
K081545 |
06/02/2008 |
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 |
ADVANCED MEDICAL OPTICS, INC. |
K070665 |
03/12/2007 |
LITHOSKOP |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K990846 |
03/15/1999 |
AMORPHOUS DIAMOND COATED DRILL |
NOBEL BIOCARE UAS INC |
K070799 |
03/23/2007 |
MODULARIS VARIOSTAR |
SIEMENS MEDICAL SOLUTIONS USA INC. |
K101347 |
05/13/2010 |
MAGNETOM AERA; MAGNETOM SKYRA |
SIEMENS MEDICAL SOLUTIONS USA INC. |
K992538 |
07/30/1999 |
AMORPHOUS DIAMOND COATED SCREW |
NOBEL BIOCARE UAS INC |
K072392 |
08/27/2007 |
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K151790 |
07/01/2015 |
PMT Platinum Depthalon Depth Electrode |
PMT CORPORATION |
K101563 |
06/04/2010 |
SMARTO |
JEIL MEDICAL CORPORATION |
K060902 |
04/03/2006 |
STARCLOSE INTRODUCER SET MODEL- 1002 |
ABBOTT VASCULAR INC. |
K051125 |
05/03/2005 |
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 |
ABBOTT LABORATORIES |
K213271 |
09/30/2021 |
MedicloseTM System |
Health Value Creation BV, trading as Corporis Medical |
K220797 |
03/18/2022 |
FootHold System |
CrossRoads Extremity Systems, LLC |
K202268 |
08/11/2020 |
CrossRoads Tray System |
CrossRoads Extremity Systems, LLC |
K223342 |
11/01/2022 |
MotoBANDÖ CP Implant System: DynaBunionÖ 4D Minimal-incision Bunion System, DynaMETÖ Lesser TMT Fusion System |
CrossRoads Extremity Systems, LLC |
K193452 |
12/13/2019 |
MotoBAND CP Implant System |
CrossRoads Extemity Systems, LLC |
K023232 |
09/27/2002 |
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE |
SMART PRACTICE |
K123184 |
10/10/2012 |
FINN CHAMBERS AQUA |
SMART PRACTICE |
K063160 |
10/17/2006 |
ALLERGEAZE PATCH TEST CHAMBERS |
SMART PRACTICE |
K103409 |
11/22/2010 |
ALLERGEAZE R CLEAR |
SMARTPRACTICE |
K012254 |
07/18/2001 |
VBR |
OSTEOTECH, INC. |
K003155 |
10/10/2000 |
VERTEBRAL BODY REPLACEMENT |
OSTEOTECH, INC. |
K003384 |
10/31/2000 |
VERSALINK TITANIUM ROD-TO-ROD COUPLERS |
OSTEOTECH, INC. |
K140096 |
01/14/2014 |
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE |
HMICRO, INC. |
K030742 |
03/10/2003 |
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM |
CRYO VASCULAR SYSTEMS INC. |
K120853 |
03/21/2012 |
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, |
BIONESS, INC. |
K961900 |
05/16/1996 |
TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
K091924 |
06/30/2009 |
VPS CATHETER |
VASONOVA INC. |
K172011 |
07/03/2017 |
LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) |
HMicro, Inc. |
K972641 |
07/15/1997 |
DUAL OFFSET PERFECTA IMC HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
K042230 |
08/17/2004 |
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM |
CRYOVASCULAR SYSTEMS, INC. |
K983104 |
09/04/1998 |
NORIAN PERIODONTAL/DENTAL CEMENT (PDC) |
NORIAN CORP. |
K122784 |
09/11/2012 |
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT |
BIONESS, INC. |
K973524 |
09/17/1997 |
ADVANCE MODULAR TIBIAL COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
K973530 |
09/18/1997 |
INFINTY DISTAL FEMORAL COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
K042541 |
09/20/2004 |
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM |
CRYOVASCULAR SYSTEMS, INC. |
K103260 |
11/04/2010 |
VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE |
VASONOVA INC. |
K974328 |
11/18/1997 |
ADVANCE TOTAL KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
K033622 |
11/18/2003 |
POLARCATH PERIPHERAL DILATATION SYSTEM |
CRYOVASCULAR SYSTEMS, INC. |
K123636 |
11/23/2012 |
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE |
BIONESS, INC. |
K083920 |
12/31/2008 |
FLOWPICC CATHETER |
VASONOVA INC. |
K103255 |
11/03/2010 |
VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET |
VASONOVA INC. |
K190044 |
01/09/2019 |
VSP Orthopedics System |
3D Systems, Inc. |
K151285 |
05/14/2015 |
VSP Cranial System |
3D Systems, Inc. |
K161841 |
07/05/2016 |
D2P |
3D SYSTEMS, INC. |
K192192 |
08/13/2019 |
VSP System |
3D Systems |
K193432 |
12/10/2019 |
Vantage PSI System |
3D Systems |
K183489 |
12/17/2018 |
D2P |
3D Systems, Inc. |
K153705 |
12/23/2015 |
PROcedure Rehearsal Studio |
3DSYSTEMS, SIMBIONIX PRODUCTS |
K050119 |
01/18/2005 |
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT |
BECKMAN COULTER, INC. |
K031002 |
03/31/2003 |
SYNCHRON SYSTEMS OPIATE REAGENT |
BECKMAN COULTER, INC. |
K032035 |
07/01/2003 |
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI |
BECKMAN COULTER, INC. |
K032287 |
07/24/2003 |
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 |
BECKMAN COULTER, INC. |
K042195 |
08/13/2004 |
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 |
BECKMAN COULTER, INC. |
K042459 |
09/10/2004 |
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT |
BECKMAN COULTER, INC. |
K151260 |
05/12/2015 |
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD |
Cardiovascular System, Inc. |
K152694 |
09/21/2015 |
Diamondback 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems Inc. |
K153407 |
11/25/2015 |
Stryker Neptune 3 Waste Management System |
STRYKER CORPORATION |
K142359 |
08/25/2014 |
Vasc Band hemostat |
Lepu Medical Technology (Beijing) Co., LTD |
K062096 |
07/24/2006 |
KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST |
KOREAMEDICO CO. LTD. |
K201296 |
05/15/2020 |
i-Rapha Solution |
IRM Inc |
K051639 |
06/20/2005 |
AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM |
AS SOFTWARE, INC. |
K040231 |
02/02/2004 |
INTELIPORT OCCLUDING DEVICE |
ALCON, INC. |
K050729 |
03/21/2005 |
ALCON MULTI-PURPOSE DISINFECTING SOLUTION |
ALCON RESEARCH, LTD. |
K031193 |
04/16/2003 |
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION |
ALCON, INC. |
K071236 |
05/03/2007 |
ALCON MULTI-PURPOSE SOLUTION |
ALCON, INC. |
K960718 |
02/21/1996 |
LRM |
LAKE REGION MFG., INC. |
K960866 |
03/04/1996 |
LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. |
LAKE REGION MFG., INC. |
K981326 |
04/13/1998 |
LAKE REGION MANUFACTURING GUIDEWIRES |
LAKE REGION MFG., INC. |
K981667 |
05/11/1998 |
HYDROPHILIC COATED GUIDEWIRE |
LAKE REGION MFG., INC. |
K041324 |
05/18/2004 |
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER |
LIFECORE BIOMEDICAL, INC. |
K192900 |
10/15/2019 |
H500 Multi-Sensing Oximetry System |
Nonin Medical, Inc. |
K160231 |
02/01/2016 |
Model X-100C CO-MetÖ Oximetry System |
NONIN MEDICAL, INC. |
K172625 |
09/01/2017 |
Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor |
Nonin Medical Inc. |
K213010 |
09/20/2021 |
FEELject LDV (Low dead volume) syringe |
Feeltech Co., Ltd. |
K050357 |
02/14/2005 |
CAMCERAM TCP |
CAM IMPLANTS B.V. |
K223029 |
09/29/2022 |
Perfit CL |
Vatech mcis Co., Ltd. |
K190139 |
01/29/2019 |
Zircos-Com |
Bioden Co., Ltd |
K193497 |
12/17/2019 |
Fixone Biocomposite Interference Screw |
AJU Pharm Co., Ltd. |
K171299 |
05/03/2017 |
Fixone Biocomposite Anchor |
AJU Pharm Co.,Ltd. |
K162070 |
07/27/2016 |
JOINIX CANNULAR SYSTEM |
AJU Pharm Co.,Ltd. |
K192484 |
09/10/2019 |
Fixone Biocomposite Anchor |
AJU Pharm Co., Ltd. |
K192709 |
09/27/2019 |
Fixone All Suture Anchor |
AJU Pharm Co.,Ltd. |
K112489 |
08/29/2011 |
SWIFT FX BELLA |
RESMED LTD. |
K171212 |
04/25/2017 |
AirFit N20 |
ResMed Ltd |
K161978 |
07/18/2016 |
AirFit N20 |
ResMed Ltd |
K153673 |
12/21/2015 |
AirFit N20 |
ResMed Ltd |
K070937 |
04/04/2007 |
MULTIPLE BRAND MALE LATEX CONDOM |
NULATEX SDN. BHD. |
K072896 |
10/11/2007 |
GS FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
K951965 |
04/27/1995 |
DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION |
DAKO CORP. |
K955706 |
12/15/1995 |
JPI AUTOMATIC X-RAY FILM PROCESSOR |
JPI HEALTHCARE CO., LTD |
K030612 |
02/26/2003 |
GENESIS II TOTAL KNEE SYSTEM |
SMITH & NEPHEW, INC. |
K010555 |
02/26/2001 |
JAX |
SMITH & NEPHEW, INC. |
K030766 |
03/11/2003 |
OXINIUM FEMORAL HEADS |
SMITH & NEPHEW, INC. |
K041976 |
07/22/2004 |
SMITH & NEPHEW GRAFT DELIVERY SYSTEM |
SMITH & NEPHEW, INC. |
K002740 |
09/01/2000 |
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS |
SMITH & NEPHEW, INC. |
K042896 |
10/20/2004 |
SMITH & NEPHEW HYBRID KNEE FEMORAL |
SMITH & NEPHEW, INC. |
K033552 |
11/12/2003 |
JAX-TCP |
SMITH & NEPHEW, INC. |
K063535 |
11/22/2006 |
CAPTION APPLICATOR |
SMITH & NEPHEW, INC. |
K083528 |
11/28/2008 |
SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 |
SMITH & NEPHEW, INC. |
K024340 |
12/27/2002 |
SMITH & NEPHEW FEMORAL HEADS |
SMITH & NEPHEW, INC. |
K193513 |
12/19/2019 |
SIGNAFUSE Bioactive Bone Graft |
Bioventus |
K021084 |
04/04/2002 |
LIGHT SABER SPINAL NEEDLE |
MINRAD, INC. |
K980591 |
02/17/1998 |
RENU MULTIPLUS LUBRICATING & REWETTING DROPS |
BAUSCH & LOMB, INC. |
K013232 |
09/27/2001 |
CYBERCASES BY BAUSCH & LOMB |
BAUSCH & LOMB, INC. |
K120215 |
01/24/2012 |
SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE |
INTUITIVE SURGICAL, INC. |
K112584 |
09/06/2011 |
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT |
INTUITIVE SURGICAL, INC. |
K203523 |
12/01/2020 |
Fixone hybrid knotless anchor |
AJU Pharm Co., Ltd. |
K152334 |
08/19/2015 |
Sungshim Insulin Pen Needle |
SUNGSHIM MEDICARE CO., LTD. |
K152803 |
09/28/2015 |
SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE |
SUNG SHIM MEDICARE CO., LTD. |
K090872 |
03/30/2009 |
MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM |
CARDICA, INC. |
K091017 |
04/09/2009 |
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 |
CARDICA, INC. |
K150372 |
02/13/2015 |
VERASENSE Knee System |
OrthoSensor, Inc. |
K130380 |
02/14/2013 |
ORTHOSENSOR KNEE BALANCER |
ORTHOSENSOR, INC. |
K041206 |
05/07/2004 |
EPITOME SYSTEM |
GEBAUER MEDIZINTECHNIK GMBH |
K062042 |
07/19/2006 |
PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) |
PLETHORA SOLUTIONS |
K072102 |
07/31/2007 |
EPIVISION SL SYSTEM |
GEBAUER MEDIZINTECHNIK GMBH |
K100303 |
02/03/2010 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY |
ANGIOSCORE, INC. |
K050500 |
02/28/2005 |
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
K150634 |
03/11/2015 |
AngioSculpt PTA Scoring Baloon Catheters |
Spectranetrics |
K081220 |
04/30/2008 |
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER |
ANGIOSCORE, INC. |
K101735 |
06/21/2010 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY |
ANGIOSCORE, INC. |
K091966 |
07/01/2009 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 |
ANGIOSCORE, INC. |
K051802 |
07/05/2005 |
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
K082059 |
07/21/2008 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
ANGIOSCORE, INC. |
K122685 |
08/31/2012 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
ANGIOSCORE, INC. |
K142983 |
10/16/2014 |
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating |
ANGIOSCORE, INC. |
K133998 |
12/26/2013 |
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING |
ANGIOSCORE, INC. |
K153293 |
11/13/2015 |
Extension Set |
B. BRAUN MEDICAL INC. |
K193279 |
11/27/2019 |
Comet II Pressure Guidewire |
Boston Scientific Corporation |
K111739 |
06/21/2011 |
KIDS ROCK 3 CHAIR |
PRIDE MOBILITY PRODUCTS CORP. |
K092088 |
07/09/2009 |
VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713 |
PRIDE MOBILITY PRODUCTS CORP. |
K092961 |
09/25/2009 |
JAZZY FRONTIE |
PRIDE MOBILITY PRODUCTS CORP. |
K112815 |
09/27/2011 |
QUANTUM BARIATRIC 451 |
PRIDE MOBILITY PRODUCT CORPORRATION |
K113488 |
11/23/2011 |
JAZZY ELITE 6 |
PRIDE MOBILITY PRODUCT CORPORRATION |
K060651 |
03/13/2006 |
PROXIS SYSTEM, MODEL EPS101 |
ST. JUDE MEDICAL |
K052523 |
09/14/2005 |
PROXIS SYSTEM |
VELOCIMED INC. |
K211701 |
06/03/2021 |
X-Guide« Surgical Navigation System |
X-Nav Technologies, LLC |
K181916 |
07/17/2018 |
d-Nav System |
Hygieia, Inc |
K132105 |
07/08/2013 |
PERCLOT TOPICAL |
CRYOLIFE, INC. |
K060801 |
03/24/2006 |
DEKNA-LOK MODEL BP1000V2L |
TELEFLEX MEDICAL |
K143383 |
11/25/2014 |
Q6 Edge EM |
Pride Mobility Product Corporation |
K190868 |
04/03/2019 |
Cleerly Labs |
Cleerly Inc |
K192705 |
09/27/2019 |
MiniCap Extended Life PD Transfer Sets |
Baxter Healthcare |
K170336 |
02/02/2017 |
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector |
Becton, Dickinson and Company |
K100402 |
02/16/2010 |
SITE-RITE VISION ULTRASOUND SYSTEM |
BARD ACCESS SYSTEMS, INC. |
K200891 |
04/03/2020 |
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System |
Becton, Dickinson and Company |
K201075 |
04/22/2020 |
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter |
Becton, Dickinson and Company |
K071204 |
05/01/2007 |
SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 |
C.R. BARD, INC. |
K161777 |
06/29/2016 |
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems |
Becton Dickinson Infusion Therapy Systems, Inc. |
K052517 |
09/14/2005 |
SITE-RITE 5 ULTRASOUND SYSTEM |
C.R. BARD, INC. |
K123734 |
12/05/2012 |
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM |
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
K183399 |
12/07/2018 |
BD Nexiva Closed IV Catheter System |
Becton Dickinson Infusion Therapy Systems Inc. |
K222872 |
09/22/2022 |
DNA Appliance |
Vivos Therapeutics, Inc. |
K091865 |
06/19/2009 |
SPORT-ELEC BODY CONTROL SYSTEM |
SPORT-ELEC |
K092142 |
07/15/2009 |
SPORT-ELEC BODY CONTROL SYSTEM BS |
SPORT-ELEC |
K081171 |
04/24/2008 |
TRITANIUM ACETABULAR SHELL SYSTEM |
HOWMEDICA OSTEONICS CORP |
K121283 |
04/30/2012 |
BD EMERALD SAF-T SINGLE USE, HYPODERMIC |
Becton, Dickinson and Company |
K091946 |
06/30/2009 |
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX |
STRYKER SPINE |
K102606 |
09/10/2010 |
AVS ANCHOR-C CERVICAL CAGE SYSTEM |
STRYKER SPINE |
K083020 |
10/09/2008 |
STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM |
STRYKER CORP. |
K093704 |
12/01/2009 |
AVS PL PEEK SPACERS |
STRYKER CORP. |
K083562 |
12/02/2008 |
STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM |
STRYKER CORP. |
K083661 |
12/10/2008 |
AVS TL PEEK SPACERS |
STRYKER CORP. |
K200522 |
03/02/2020 |
AERO CHROME* Breathable Performance Surgical Gowns |
O&M Halyard, Inc |
K210688 |
03/08/2021 |
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown |
O&M Halyard, Inc |
K192362 |
08/30/2019 |
Aero Blue Performance Surgical Gowns |
O&M Halyard, Inc. |
K131301 |
05/07/2013 |
BD FACS SAMPLE PREP ASSISTANT III |
BECTON DICKINSON & CO. |
K120579 |
02/27/2012 |
SOMATOM DEFINITION EDGE |
SIEMENS MEDICAL SYSTEMS, INC. |
K190578 |
03/06/2019 |
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence |
Siemens Medical Solutions USA Inc. |
K150745 |
03/23/2015 |
syngo.CT Single Source Dual Energy |
Siemens Medical Solutions USA, Inc. |
K150757 |
03/23/2015 |
syngo.CT Dual Energy |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K170952 |
03/31/2017 |
syngo.CT View&GO |
Siemens Medical Solutions USA, Inc. |
K130901 |
04/01/2013 |
SOMATOM DEFINITION AS OPEN |
SIEMENS MEDICAL SYSTEMS, INC. |
K121072 |
04/09/2012 |
SOMATOM DEFINITION FLASH |
SIEMENS MEDICAL SYSTEMS, INC. |
K140920 |
04/10/2014 |
SYNGO.CT COLONOGRAPHY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K161196 |
04/27/2016 |
SOMATOM Drive |
Siemens Medical Solutions USA, Inc. |
K151765 |
06/30/2015 |
SOMATOM Perspective |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K151887 |
07/10/2015 |
syngo VSim |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K152036 |
07/22/2015 |
SOMATOM Definition Edge, SOMATOM Definition AS/AS+ |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K162302 |
08/17/2016 |
Somatom Confidence « RT Pro |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K162370 |
08/24/2016 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
K132902 |
09/16/2013 |
SYNGO DUAL ENERGY SOFTWARE PACKAGE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K122909 |
09/21/2012 |
SYNGO SINGLE SOURCE DUAL ENGERY |
SIEMENS MEDICAL SYSTEMS, INC. |
K142955 |
10/14/2014 |
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K153220 |
11/06/2015 |
syngo.CT Single Source Dual Energy (Twin Beam) |
Siemens Medical Solutions USA, Inc. |
K133424 |
11/08/2013 |
SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K123540 |
11/19/2012 |
SYNGO CT PULMO 3D |
SIEMENS MEDICAL SYSTEMS, INC. |
K123541 |
11/19/2012 |
SYNGO.CT NEURO PERFUSION |
SIEMENS MEDICAL SYSTEMS, INC. |
K123585 |
11/21/2012 |
SYNGO, CT CARDIAC FUNCTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K123584 |
11/21/2012 |
SYNGO, CT BONE READING |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K133590 |
11/22/2013 |
SOMATOM PERSPECTIVE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K133589 |
11/22/2013 |
SOMATOM FORCE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K163284 |
11/22/2016 |
syngo. CT Neuro Perfusion |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K163296 |
11/22/2016 |
SOMATOM go.Up, SOMATOM go.Now |
Siemens Medical Solutions USA, Inc. |
K163289 |
11/22/2016 |
syngo. CT Single Source Dual Energy (twin beam) |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
K163297 |
11/22/2016 |
Scan&GO |
Siemens Medical Solutions USA, Inc. |
K183272 |
11/23/2018 |
AI Rad Companion (Engine) |
Siemens Medical Solutions USA, Inc. |
K183271 |
11/23/2018 |
AI-Rad Companion (Pulmonary) |
Siemens Medical Solutions USA, Inc. |
K173637 |
11/24/2017 |
syngo.CT Coronary Analysis; syngo.CT Vascular Analysis |
Siemens Medical Solutions USA, Inc. |
K173625 |
11/24/2017 |
syngo.CT Clinical Extensions |
Siemens Medical Solutions USA, Inc. |
K173632 |
11/24/2017 |
SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO |
Siemens Medical Solutions USA, Inc. |
K173635 |
11/24/2017 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
K173630 |
11/24/2017 |
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence |
Siemens Medical Solutions USA, Inc. |
K133643 |
11/27/2013 |
SYNGO, CT LIVER ANALYSIS |
SIEMENS MEDICAL SOLUTIONS, INC. |
K133646 |
11/27/2013 |
ADMIRE |
SIEMENS MEDICAL SYSTEMS, INC. |
K133648 |
11/27/2013 |
SYNGO, CT DUAL ENERGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K143401 |
11/28/2014 |
SOMATOM Definition Edge |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K143400 |
11/28/2014 |
SOMATOM Definition AS/AS+ |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K133677 |
11/29/2013 |
SYNGO CT SINGLE SOURCE DUAL ENERGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K163341 |
11/29/2016 |
syngo.CT Extended Functionality |
SIEMENS MEDICAL SOLUTIONS USA, Inc. |
K213867 |
12/10/2021 |
Carestation 750/750c |
Datex-Ohmeda, Inc. |
K183548 |
12/20/2018 |
SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 |
Siemens Medical Solutions USA, Inc. |
K122471 |
08/14/2012 |
SOMATOM DEFINITION |
SIEMENS MEDICAL SYSTEMS, INC. |
K133936 |
12/23/2013 |
ARTUS C. DIFFICILE QS-RGQ MDX KIT |
QIAGEN, GMBH |
DEN180013 |
03/15/2018 |
PREVENA 125 and PREVENA PLUS 125 Therapy Units |
KCI USA, Inc. |
K180855 |
04/02/2018 |
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System |
KCI USA, Inc. |
K051301 |
05/19/2005 |
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES |
ETHICON ENDO-SURGERY, INC. |
K181507 |
06/07/2018 |
PREVENA RESTOR(TM) Incision Management System |
KCI USA, Inc. |
K141804 |
07/03/2014 |
POLARIS SPINAL SYSTEM - HA COATED |
BIOMET SPINE LLC, |
K122417 |
08/08/2012 |
SCOPEVALET DISPOSABLE BIOPSY VALVE |
THE RUHOF CORP. |
K133518 |
11/15/2013 |
MAXAN ANTERIOR CERVICAL PLATE SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
K042732 |
10/01/2004 |
ARCHITECT CA 15-3 ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
K042731 |
10/01/2004 |
ARCHITECT CA 125 II ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
K033731 |
11/28/2003 |
AXSYM CORTISOL ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
K130794 |
03/22/2013 |
CELLTRACKS ANALYZER II SYSTEM |
VERIDEX, LLC |
K122821 |
09/14/2012 |
CELLTRACKS AUTOPREP SYSTEM |
VERIDEX, LLC |
K071015 |
04/10/2007 |
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K183268 |
11/23/2018 |
AI-Rad Companion (Cardiovascular) |
Siemens Medical Solutions USA, Inc. |
K092476 |
08/12/2009 |
SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M |
SPORT-ELEC |
K132236 |
07/18/2013 |
.DECIMAL PROTON APERTURE |
.DECIMAL, INC. |
K173294 |
10/16/2017 |
Magnesium |
Abbott Laboratories |
K070151 |
01/16/2007 |
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER |
ETHICON ENDO-SURGERY, LLC |
K050344 |
02/11/2005 |
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER |
ETHICON ENDO SURGERY, INC. |
K031147 |
04/10/2003 |
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR |
ETHICON ENDO-SURGERY, INC. |
K051950 |
07/18/2005 |
INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 |
ETHICON ENDO-SURGERY, INC. |
K042777 |
10/06/2004 |
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P |
ETHICON ENDO-SURGERY, INC. |
K190078 |
01/16/2019 |
IntraSight |
Volcano Corporation |
K140311 |
02/07/2014 |
CARESITE LUER ACCESS DEVICE |
B. BRAUN MEDICAL, INC. |
K171584 |
05/31/2017 |
B. Braun Tear-Away Introducer Needle |
B. Braun Medical Inc. |
K131842 |
06/21/2013 |
STERICAN CANNULA |
B. BRAUN MEDICAL, INC. |
K212842 |
09/07/2021 |
Microvolume Luer Access Device |
B. Braun Medical Inc. |
K202618 |
09/10/2020 |
IV Administration Sets |
B. Braun Medical Inc. |
K173803 |
12/15/2017 |
Omnican fine |
B. Braun Medical Inc. |
K223073 |
09/30/2022 |
Alio |
Alio, Inc. |
K090915 |
04/01/2009 |
STERILE WATER FOR INHALATION FLEX BAG, USP |
CARDINAL HEALTH, INC. |
K091853 |
06/23/2009 |
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 |
NSPIRE HEALTH, INC. |
K131512 |
05/28/2013 |
KATIA SYSTEM |
SHANGHAI SANYOU MEDICAL CO, LTD |
K132731 |
09/03/2013 |
DIGIFIX EXTERNAL FIXATION SYSTEM |
VIRAK ORTHOPEDIC RESEARCH, LLC |
K231021 |
04/10/2023 |
KIMTECHÖ PolarisÖ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
Kimberly-Clark Corporation |
K231435 |
05/17/2023 |
KIMTECHÖ PolarisÖ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
Kimberly-Clark Corporation |
K090649 |
03/11/2009 |
VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE |
VIRTUAL RADIOLOGIC CORPORATION |
K191536 |
06/10/2019 |
Biatain Silicone Ag |
Coloplast A/S |
K182388 |
09/04/2018 |
Krystal Klear Aligners |
Shatkin F.I.R.S.T. LLC |
K070163 |
01/17/2007 |
SWABBABLE CAP, MODEL 60205 |
BAXA CORP. |
K062909 |
09/27/2006 |
REPEATER PUMP II TUBE SETS |
BAXA CORP. |
K004025 |
12/27/2000 |
SPLITTABLE SHEATH INTRODUCER KIT |
THOMAS MEDICAL PRODUCTS, INC. |
K091281 |
05/01/2009 |
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA |
PROCTER & GAMBLE CO. |
K041935 |
07/19/2004 |
DR SYSTEMS PACS, RELEASE 6.1 |
DR. SYSTEMS, INC. |
K143318 |
11/19/2014 |
DR Systems Zero Download 3D Viewer (Z3D) |
DR Systems, Inc |
K032371 |
08/01/2003 |
TITANIUM MESH SYSTEM |
ENCORE MEDICAL, L.P. |
K032905 |
09/17/2003 |
3DKNEE POROUS COATED FEMORAL COMPONENT |
ENCORE ORTHOPEDICS, INC. |
K062025 |
07/18/2006 |
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 |
CORGENIX, INC. |
K100865 |
03/29/2010 |
AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX |
STRYKER SPINE |
K101051 |
04/15/2010 |
AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX |
STRYKER SPINE |
K093864 |
12/17/2009 |
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX |
STRYKER CORP. |
K110186 |
01/21/2011 |
SYNAPSE 3D LIVER ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
K113284 |
11/07/2011 |
BIOPSY POSITIONER |
FUJI FILM MEDICAL SYSTEMS |
K103720 |
12/21/2010 |
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
K163470 |
12/12/2016 |
Galvanic Spa, Model: SKB-1405 |
ShenZhen Siken 3D Technology Development Co., Ltd. |
K171155 |
04/20/2017 |
Surgical Angle Handpiece, Surgical Straight Handpiece |
Nakanishi Inc. |
K182999 |
10/30/2018 |
General Cutting Contra Handpiece |
Nakanishi Inc. |
K163131 |
11/08/2016 |
A-dec NLZ Electric Motor System |
NAKANISHI, INC. |
K163402 |
12/05/2016 |
NLZ Motor System |
NAKANISHI INC. |
K163483 |
12/12/2016 |
PANA SPRAY Plus |
NAKANISHI, INC. |
K173905 |
12/22/2017 |
Surgic Pro, Surgic Pro+ |
Nakanishi Inc. |
K203833 |
12/30/2020 |
Tacrolimus Assay Kit |
Shanghai Genext Medical Technology Co., Ltd. |
K955434 |
10/02/1995 |
ACCESS FOLATE ASSAY (MODIFICATION) |
BECKMAN COULTER, INC. |
K212283 |
07/21/2021 |
BioRoot Flow 0.5g, BioRoot Flow 2g |
Septodont |
K211799 |
06/10/2021 |
Biodentine XP 500, Biodentine XP 200 |
Septodont |
K210115 |
01/19/2021 |
FiteBac CC OrthoSeal |
Largent Health, LLC |
K190271 |
02/08/2019 |
FiteBac Cavity Cleanser |
Largent Health, LLC |
K200614 |
03/09/2020 |
FiteBac Antimicrobial Cavity Cleanser |
Largent Health, LLC |