FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K230847 |
09/29/2023 |
Chemotherapy Gloves |
3A Glove Sdn. Bhd. |
Kumar Durarajen |
K233257 |
09/29/2023 |
3MÖ ClarityÖAligners with Quick Attachments |
3M Company, Unitek Orthodontic Products |
Hillary Peetsch |
K231739 |
09/25/2023 |
Cervical Spine Truss System (CSTS) |
4Web Medical, Inc. |
Lewis Harrison |
K230966 |
09/19/2023 |
angiOCCLUDE Ligating Clips |
A2 Medical Systems, LLC |
Robert Hall |
K214117 |
09/27/2023 |
AfinionÖ HbA1c, AfinionÖ 2 and Alere AfinionÖ AS100 Analyzer |
Abbott Diagnostics Technologies AS |
Danial Kirmani |
K232669 |
09/29/2023 |
TBI |
Abbott Laboratories |
Lisa Kelly |
K232690 |
09/29/2023 |
AmuletÖ Steerable Delivery Sheath |
Abbott Medical |
Dan Gapp |
K232386 |
09/08/2023 |
ILUMIENÖ OPTISÖ System, OPTISÖ Integrated System, OPTISÖ Mobile System, with AptiVueÖ Imaging Software version E.6 |
Abbott Medical |
Derek Pike |
K223755 |
09/11/2023 |
i-STAT G cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Mojgan Soleimani |
K223857 |
09/15/2023 |
i-STAT G3+ cartridge with the i-STAT 1 System |
ABBOTT POINT OF CARE, INC |
Jacquelyn Gesumaria |
K230980 |
09/22/2023 |
MicroMatrix« Flex |
ACell, Inc. |
Simone Oliver |
K232592 |
09/20/2023 |
CITRELOCK« DUO |
Acuitive Technologies, Inc. |
Matthew Poggie |
DEN230021 |
09/13/2023 |
ensoETM |
Advanced Cooling Therapy, Inc. d/b/a Attune Medical |
Erik Kulstad |
K232701 |
09/29/2023 |
Guardenia (GAR-1) |
Advanced Surgical Concepts |
Edward Hyland |
K223659 |
09/22/2023 |
Jazz |
AI Medical AG |
Christian Federau |
K223179 |
09/20/2023 |
Cholestech LDX Ö System |
Alere San Diego, Inc. |
Nathifa Bradshaw |
K231146 |
09/08/2023 |
AliTight |
Alic Iotech, LLC |
Like Zeng |
K230649 |
09/07/2023 |
Arm Blood Pressure Monitor |
Alicn Medical Shenzhen, Inc |
Fang Meisong |
K232233 |
09/26/2023 |
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks |
Align Technology, Inc. |
John Ray |
K221570 |
09/29/2023 |
Antibacterial bandage |
Allmed Medical Products Co., Ltd. |
Vince Tian |
K223621 |
09/08/2023 |
DeepXray |
Alpha Intelligence Manifolds, Inc. |
Qingzong Tseng |
K232413 |
09/08/2023 |
Fusion Robotic Navigation System |
Alphatec Spine, Inc. |
Sarah Braun |
K232097 |
09/25/2023 |
IdentiTi ALIF Interbody Systems |
Alphatec Spine, Inc. |
Andrew Zhang |
K232275 |
09/27/2023 |
Invictus« Spinal Fixation System |
Alphatec Spine, Inc. |
Cynthia Dorne |
K230925 |
09/27/2023 |
Disposable Injection Needle AF series |
Alton (Shanghai) Medical Instruments Co. Ltd |
Vivian Li |
K232582 |
09/20/2023 |
Ambu« aScopeÖ 5 Broncho 4.2/2.2 Sampler Set |
Ambu A/S |
Eva Lind Rasmussen |
K230332 |
09/15/2023 |
Ambu« aScopeÖ Colon; Ambu« aBoxÖ 2 |
Ambu A/S |
Mette Andersen |
K230043 |
09/20/2023 |
Insulin Pen Needle |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Bingyi Xiang |
K231767 |
09/22/2023 |
Annalise Enterprise CTB Triage Trauma |
Annalise-AI Pty Ltd |
Haylee Bosshard |
K231384 |
09/22/2023 |
Annalise Enterprise CTB Triage Trauma |
Annalise-AI Pty Ltd. |
Haylee Bosshard |
K232699 |
09/28/2023 |
Low Ejection Fraction AI-ECG Algorithm |
Anumana, Inc. |
Suzanne Goodman |
K223901 |
09/01/2023 |
ApneaRX Pro |
Apnea Sciences Coporation |
James Fallon |
K232544 |
09/18/2023 |
Apollo ESG NXT System, Apollo REVISE NXT System |
Apollo Endosurgery Inc. |
James Shene |
K232443 |
09/07/2023 |
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit |
Argon Medical Devices, Inc. |
Ana Jimenez-Hughes |
K230824 |
09/06/2023 |
IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) |
Art Optical Contact Lens, Inc. |
Jill Anastor |
K231353 |
09/14/2023 |
AccuCTP Pro |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
K230513 |
09/26/2023 |
Arthrex Univers Apex OptiFit Humeral Stem |
Arthrex Inc |
Tiffany Mentzel |
K232340 |
09/01/2023 |
Arthrex 2.4mm Knotless Hip SutureTak« Suture Anchor |
Arthrex Inc. |
Alex Underberg |
K231649 |
09/29/2023 |
Intraosseous Fusion Device System |
Auxano Medical LLC |
Jennifer Hazou |
K231242 |
09/15/2023 |
Perifix FX Catheter; Contiplex FX Catheter |
B. Braun Medical Inc. |
Tracy Larish |
K222251 |
09/18/2023 |
B╖R╖A╖H╖M╖S CgA II KRYPTOR, B╖R╖A╖H╖M╖S CgA II KRYPTOR CAL, B╖R╖A╖H╖M╖S CgA II KRYPTOR QC |
B.R.A.H.M.S GmbH part of Thermo Fisher |
Anne Kummerow |
K231827 |
09/15/2023 |
BTI Dental Implant System UnicCa« û Aesthetic Post Abutments |
B.T.I. Biotechnology Institute, S.L. |
JosΘ Ram≤n Rivero |
K231092 |
09/22/2023 |
T-SHAPE 2 |
B&M S.R.L. Marketing Nel Benessere |
Brando Baldan |
K230987 |
09/14/2023 |
FlowStar Analog Mixer Flowmeter |
Baldus Sedation GmbH & Co. KG |
Lisa Baldus |
K230609 |
09/13/2023 |
NG Delivery Catheter |
Balt USA, LLC |
Catherine Chiou |
K231283 |
09/11/2023 |
SiteRiteÖ 9 Ultrasound System |
Bard Access Systems, Inc. (C.R. Bard, Inc.) |
Fabio De Pasquale |
K232467 |
09/14/2023 |
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine |
Baxter Healthcare Corporation |
Kristen Bozzelli |
K223921 |
09/22/2023 |
Access CEA |
Beckman Coulter, Inc |
Abhi Kannan |
K231832 |
09/18/2023 |
Access Myoglobin |
Beckman Coulter, Inc |
Kate Oelberg |
K220972 |
09/15/2023 |
Access Thyroglobulin |
Beckman Coulter, Inc |
Abhi Kannan |
K213517 |
09/26/2023 |
Access Thyroglobulin Antibody II |
Beckman Coulter, Inc. |
Abhi Kannan |
K231239 |
09/22/2023 |
NexivaÖ Closed IV Catheter System with NearPortÖ IV Access |
Becton Dickinson Infusion Therapy Systems Inc. |
Paul Holman |
K230865 |
09/28/2023 |
PIVOÖ Pro Needle-free Blood Collection Device |
Becton Dickinson Infusion Therapy Systems, Inc. |
Amy Moore |
K230024 |
09/06/2023 |
HI-EMT MAGSHAPE |
Beijing Sano Laser S&T Development Co., Ltd |
Hongbo Zhang |
K223919 |
09/23/2023 |
B.Light Clear Evo and B.Light Restore Evo |
Bemer INT. AG |
Sandra Schwarzenberger |
K231628 |
09/29/2023 |
BeShape OneÖ Device |
BeShape Technologies Ltd. |
Amit Goren |
K232224 |
09/22/2023 |
iLet« Dosing Decision Software |
Beta Bionics, Inc. |
Liz Cooper |
K213987 |
09/20/2023 |
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls |
Biokit, S.A. |
Angels Roma |
K231207 |
09/07/2023 |
CARTOÖ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) |
Biosense Webster, Inc. |
Caleb Lau |
K230884 |
09/26/2023 |
AVVIGO'+ Multi-Modality Guidance System |
Boston Scientific Corporation |
Kevin Catalano |
K232651 |
09/29/2023 |
BLAZERÖ Dx-20 Bidirectional Steerable Diagnostic Catheter |
Boston Scientific Corporation |
Laura Wotta |
K230735 |
09/13/2023 |
Ultimate rTMS; Yingchi rTMS |
Brain Ultimate, Inc. |
Frank Ge |
K223864 |
09/09/2023 |
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial |
Brainlab AG |
Esther Moreno Garcia |
K231837 |
09/28/2023 |
Brainomix 360 Triage LVO |
Brainomix Limited |
Thais Sala |
K232172 |
09/18/2023 |
BTL-785BNF Handpiece |
BTL Industries Inc. |
David Chmel |
K230467 |
09/21/2023 |
BTL-899F |
BTL Industries Inc. |
David Chmel |
K221601 |
09/01/2023 |
MS-39 |
C.S.O. S.r.l. |
Gilda Mura |
K231281 |
09/19/2023 |
Aquilion Serve (TSX-307A/1) V1.3 |
Canon Medical Systems Corporation |
Paul Biggins |
K231748 |
09/12/2023 |
Cartesion Prime (PCD-1000A/3) V10.15 |
Canon Medical Systems Corporation |
Paul Biggins |
K232526 |
09/12/2023 |
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 |
Canon Medical Systems Corporation |
Paul Biggins |
K231538 |
09/27/2023 |
FreedomFlow Orbital Circumferential Atherectomy System |
Cardio Flow, Inc. |
Michael J. Kallok |
K221640 |
09/13/2023 |
AlloMap Heart Molecular Expression Testing |
CareDx, Inc. |
Camilla Lu |
K231888 |
09/25/2023 |
BD TexiumÖ Needle-Free Syringe |
Carefusion |
Breanna Casados |
K232159 |
09/21/2023 |
QEVO System |
Carl Zeiss Meditec AG |
Eva Jankovics |
K230350 |
09/22/2023 |
VISULAS yag |
Carl Zeiss Meditec Inc |
Tanesha Bland |
K232583 |
09/20/2023 |
Catalyst R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
K222638 |
09/27/2023 |
Xpert« Xpress GBS, GeneXpert« Dx System, GeneXpert« Infinity Systems |
Cepheid |
Suzette Chance |
K230881 |
09/11/2023 |
Change Healthcare Cardiology HemodynamicsÖ |
Change Healthcare Israel Ltd. |
Alona Golik |
K232068 |
09/01/2023 |
HyperLight Portable X-ray Unit |
Changzhou Sifary Medical Technology Co., Ltd. |
Tao Huan |
K223869 |
09/14/2023 |
ChoiceSpine Blackhawk Ti Cervical Spacer System |
ChoiceSpine, LLC |
Kim Finch |
K232102 |
09/15/2023 |
ClearPoint Array System (Version 1.2) |
ClearPoint Neuro, Inc. |
Brennan Sullivan |
K231335 |
09/08/2023 |
Cleerly ISCHEMIA |
Cleerly, Inc |
Candice Bautista-Biddle |
K231891 |
09/25/2023 |
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit |
Coloplast |
Jennifer Mrkvicka |
K231576 |
09/14/2023 |
cNeuro cPET |
Combinostics Oy |
Thurfjell Lennart |
K232426 |
09/08/2023 |
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts |
Conformis Inc |
Mary Kruitwagen |
K230239 |
09/20/2023 |
AirSeal iFS System; AirSeal dV Solution |
CONMED Corporation |
Tina Mornak |
K231047 |
09/01/2023 |
UniSyn Molecular Imaging (6-3-1) |
Convergent Imaging Solutions |
Mathew Thomas |
K213273 |
09/01/2023 |
Brain Anesthesia Response Monitor (Bar Monitor) |
Cortical Dynamics Ltd |
Louis Delacretaz |
K232686 |
09/08/2023 |
CorVista« System |
CorVista Health, Inc. |
Gabrielle Zaeska |
K231240 |
09/08/2023 |
MaxTackÖ Motorized Fixation Device |
Covidien |
Megha Patel |
K230591 |
09/29/2023 |
TriLEAP Plating System |
CrossRoads Extremity Systems |
Keith Knapp |
K232556 |
09/20/2023 |
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System |
Depuy Ireland UC |
Susan Mullane |
K232178 |
09/19/2023 |
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) |
DRGEM Corporation |
Park Sunghee |
K232487 |
09/14/2023 |
Provecta 3D Prime and Provecta 3D Prime Ceph |
Durr Dental SE |
Oliver Lange |
K212769 |
09/29/2023 |
DYNEX SmartPLEX MMRV IgG Assay Kit |
Dynex Technologies Inc. |
Jeff Fisher |
K232336 |
09/26/2023 |
ES Series V2 |
E-Scopics |
Claude Cohen Bacrie |
K230184 |
09/25/2023 |
Holter ECG and ABP System |
Edan Instruments, Inc. |
Lavender Wang |
K231248 |
09/21/2023 |
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform |
Edwards Lifesciencess LLC |
Anne Lo |
K231971 |
09/26/2023 |
DEKA PHYSIQ 360 |
El.En. S.p.A |
Paolo Peruzzi |
K232334 |
09/01/2023 |
DEKA SIMON |
El.En. S.p.A. |
Paolo Peruzzi |
K230317 |
09/01/2023 |
Elos Accurate Hybrid Base |
Elos Medtech Pinol A/S |
Lise Terkelsen |
K232596 |
09/27/2023 |
EndoGI S-Path Biliary Stent System |
EndoGI Medical, Ltd. |
Omri Naveh |
K213767 |
09/12/2023 |
Endure ETCO2/02 Nasal Cannula |
Endure Industries Inc |
Manoj Kumar |
K232014 |
09/01/2023 |
CONDUITÖ ATP Inserters |
Enztec Limited |
James Sheat |
K223674 |
09/01/2023 |
eZSUREÖ Empty Fluid Container (models 426030, 426040, 426110) |
Epic Medical Pte Ltd |
Freddie Lee |
K231928 |
09/25/2023 |
EFAI RTSUITE CT HCAP-Segmentation System |
Ever Fortune.AI Co., Ltd. |
Joseph Chang |
K232002 |
09/11/2023 |
Vantage« Total Ankle System |
Exactech Inc. |
Liz Howell |
K223933 |
09/25/2023 |
Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws |
Exactech, Inc |
Valdimir Talley |
K223833 |
09/14/2023 |
Exactech« Equinoxe« Reverse Humeral Liners and Humeral Adapter Trays |
Exactech, Inc |
Liz Howell |
K223622 |
09/01/2023 |
FaceHeart Vitals Software Development Kit (FH vitals SDK) |
FaceHeart Corp. |
Morris Chung |
K231730 |
09/22/2023 |
FemaSeed Intratubal Insemination |
Femasys Inc. |
Christine Thomas |
K231141 |
09/08/2023 |
STarFix Designer Software C0265 |
FHC, Inc. |
Kelly Moeykens |
K223684 |
09/05/2023 |
F&P 820 Humidification System |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
K231446 |
09/22/2023 |
Single-Use Latex Sterile Surgical Gloves (SG100) |
Fitone Latex Products Co., Ltd. Guangdong |
Christine Ou |
K231977 |
09/25/2023 |
PEACH 2, PEACH 2 Duo, PEACH 2 go |
Foreo Inc. |
Evan Feldstein |
K220179 |
09/22/2023 |
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors |
Foshan COXO Medical Instrument Co., Ltd. |
Zheng Yongjian |
K231717 |
09/06/2023 |
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 |
Foshan Jindi Electric Appliance Co.,Ltd |
Zhaozhi Li |
K221274 |
09/29/2023 |
StarFormer, TightWave |
Fotona d.o.o. |
Tina Bartolic |
K223827 |
09/08/2023 |
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 |
FUJIFILM Corporation |
Randy Vader |
K232314 |
09/01/2023 |
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) |
Fujifilm Healthcare Americas Corporation |
Chaitrali Kulkarni |
K230752 |
09/15/2023 |
Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) |
Fujifilm Healthcare Americas Corporation |
Kotei Aoki |
K231892 |
09/12/2023 |
Definium Pace Select |
GE Hualun Medical Systems Co. Ltd. |
Miny Liu |
K232569 |
09/21/2023 |
CAREMIBRAIN |
General Equipment for Medical Imaging, S.A. |
Maria Climent |
K232158 |
09/13/2023 |
GenX-CR |
Genoray Co., Ltd. |
Inyoung Kim |
K223214 |
09/21/2023 |
Powder-Free Nitrile Examination Gloves |
Global Protection Corp. |
Christina Cataldo |
K231342 |
09/20/2023 |
Insufflator (OPTO-IFL1000) |
Guangdong OptoMedic Technologies, Inc. |
Weijuan Guo |
K231363 |
09/27/2023 |
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) |
Hantech Medical Device Co., Ltd. |
Arnold Yang |
K222921 |
09/08/2023 |
Minuteful-kidney test |
Healthy.io Ltd. |
Ron Zohar |
K230237 |
09/14/2023 |
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) |
Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. |
Chen Yang |
K232189 |
09/14/2023 |
OrionXR |
Hoth Intelligence Inc. |
Jonathan Cohen |
K222988 |
09/01/2023 |
neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical |
HT Medical d.b.a. Xenix Medical |
Ryan Phillips |
K221052 |
09/25/2023 |
Self-Fitting hearing aids |
Huizhou Jinghao Medical Technology Co., Ltd. |
Yuanxia Mao |
K230102 |
09/21/2023 |
Smart double sides wearable breast pump, Electric bilateral breast pump |
Huizhou LVB Maternal And Infant Supplies Co,Ltd. |
Dongan Zhang |
K230743 |
09/05/2023 |
ICHOR 14F Embolectomy System |
ICHOR |
Angela Mallery |
K231791 |
09/15/2023 |
PENTO Nd:YAG and Alexandrite laser system |
Ilooda Co,.Ltd. |
Mason Moon |
K223811 |
09/13/2023 |
Lung-CAD |
Imagen Technologies, Inc |
Rebecca Jones, PhD |
K221817 |
09/22/2023 |
ALFIS Vitamin D, ALFIS-3 Analyzer |
Immunostics Inc. |
Young Mi Kim |
K231688 |
09/16/2023 |
ImPACT Version 4 |
ImPACT Applications, Inc. |
Michael Zagorski |
K231108 |
09/27/2023 |
Talon Transseptal Sheath |
Inari Medical, Inc. |
Ellen Nguyen |
K231973 |
09/29/2023 |
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove |
Ineo Tech Sdn Bhd |
Pierre Hoerner |
K232260 |
09/27/2023 |
Thinline Sheath Introducer |
Inneuroco Inc. |
Marc Litzenberg |
K231819 |
09/05/2023 |
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw |
Innovate Orthopaedics Limited |
Mike Bilson |
K231663 |
09/18/2023 |
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece |
Innovative Health Technologies (NZ), Ltd |
Chapman Philip |
K220458 |
09/29/2023 |
UltraFlo-R Push Button Blood Collection Set |
Innovative Medical Technologies, Inc. |
Brad Brown |
K213403 |
09/29/2023 |
Aptiva CTD Essential Reagent |
Inova Diagnostics, Inc. |
Andrea Seaman |
K230108 |
09/14/2023 |
Straumann« BLC and TLC Implants |
Institut Straumann AG |
Corinne Arimatea |
K221359 |
09/29/2023 |
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-▀2 Glycoprotein-I IgM |
Instrumentation Laboratory Co. |
Nikita Malladi |
K231147 |
09/14/2023 |
HammerdesisÖ Interphalangeal Fusion System |
Intelivation |
David Posillico |
K230623 |
09/01/2023 |
KITE Distal Fibula Kit |
Intrauma S.p.A |
Piero Costa |
DEN210011 |
09/29/2023 |
Invitae Common Hereditary Cancers Panel |
Invitae Corporation |
Elaine Cull |
K230517 |
09/11/2023 |
Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) |
Jarmon Medical, LLC (DBA Legends Orthopedics) |
Jeremy Jarmon |
K221743 |
09/07/2023 |
Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes |
Jiangsu Bonss Medical Technology Co., Ltd. |
Feir Zeng |
K213413 |
09/01/2023 |
Hemostatic Dressing |
Jiangsu NewValue Medical Products Co., Ltd. |
Lu Wang |
K230598 |
09/12/2023 |
Stone Extraction Baskets |
Jiangsu Vedkang Medical Science and TechnologyCo.,Ltd |
Qian Wen |
K230974 |
09/15/2023 |
NIDOÖ Pedicle Screw System |
Kalitec Medical |
Keith Cannon |
K223885 |
09/14/2023 |
HOPKINS Telescopes |
Karl Storz Endoscopy America, Inc. |
Jordan Lydia Verla |
K230535 |
09/08/2023 |
KARL STORZ Urological Laser Accessories |
Karl Storz SE & CO. KG |
Alita McElroy |
K200583 |
09/05/2023 |
Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL |
Ki Mobility LLC |
Mark Murphy |
K201869 |
09/05/2023 |
Ki Power Tilt System |
Ki Mobility LLC |
Mark Murphy |
K230644 |
09/07/2023 |
Signum opaque F |
Kulzer, LLC |
David Vincent |
K231766 |
09/12/2023 |
Skyway Anterior Cervical Plate System |
Kyocera Medical Technologies, Inc. (KMTI) |
Joey Thompson |
K232571 |
09/22/2023 |
CATHTONGÖ II PICC Catheter |
L&Z US, Inc. |
James Li |
K232594 |
09/22/2023 |
CATHTONGÖ II PICC Catheter |
L&Z US, Inc. |
James Li |
DEN220026 |
09/26/2023 |
VasQ |
Laminate Medical Technologies Ltd. |
Orit Yarden |
K232605 |
09/28/2023 |
Sacrix« Sacroiliac Joint Fusion Device System, Inspan« ScrewLES Fusion System, Invue« MAXÖ + Invue Inset Anterior Cervical Plate System, and FacetFuse« Screw Fixation System |
LESspine Innovations |
Vito Lore |
K231687 |
09/07/2023 |
Gradual Dental Zirconia Blank |
Liaoning UPCERA CO., Ltd |
Li Luo |
K232827 |
09/14/2023 |
LightForce Orthodontic System |
LightForce Orthodontics |
Jeffrey Roberts |
K231957 |
09/29/2023 |
SafeBreak« Vascular |
Lineus Medical |
Vance Clement |
K232274 |
09/28/2023 |
IPL hair removal device |
Lumenessa Corp |
Peter Kim |
K232389 |
09/07/2023 |
Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue |
Masimo Corporation |
Kertana Shankar |
K231112 |
09/12/2023 |
Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner |
Materialise NV |
Giulia Girola |
K230011 |
09/20/2023 |
Mpact Extension |
Medacta International S .A. |
Stefano Baj |
K223421 |
09/20/2023 |
MedCAD AccuPlan Orthopedics System |
MedCAD |
Brian Buss |
K230398 |
09/26/2023 |
MedCAD« AccuPlate« 3DTi Patient-Specific Plating System |
MedCAD |
Brian Buss |
K220396 |
09/26/2023 |
EasyStat 300 |
Medica corporation |
Photios Makris |
K231901 |
09/28/2023 |
Hakon, Hakon Smart |
Medical San Ind·stria de Equipamentos MΘdicos Ltda |
Francis Laion de Padua |
K230918 |
09/01/2023 |
MasterX 800 Series |
Medicatech USA |
George Makar |
K231106 |
09/19/2023 |
Accuject Refra Injector AR2900 |
Medicel AG |
Erik Braziulis |
K223835 |
09/18/2023 |
MA-40, MA-112 |
Medify Air LLC |
Pragati Anand |
K231527 |
09/29/2023 |
TriALTIS Navigation Enabled Instruments |
Medos International S└RL |
Nicole Aeschbacher |
K231479 |
09/22/2023 |
TriALTIS Spine System |
Medos International SARL |
Megan Smith |
K223788 |
09/15/2023 |
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter |
MedSource International LLC |
Amanda Salentine |
K231011 |
09/12/2023 |
Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse |
Meridian AG |
Eric Odenheimer |
K232609 |
09/27/2023 |
Micro AceÖ Advanced Micro Access System |
Merit Medical Systems, Inc. |
Garry Courtney |
K232299 |
09/29/2023 |
CeraPutty |
Meta Biomed Co., Ltd. |
Suk Song Oh |
K230127 |
09/06/2023 |
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
K231007 |
09/27/2023 |
CEDIA Heroin Metabolite (6-AM) Assay |
Microgenics Corporation |
Amrit Takhar |
K230563 |
09/27/2023 |
EVOLUTION« Hinge Knee System |
MicroPort Orthopedics Inc. |
Ryan Ross |
K230775 |
09/14/2023 |
SOFIA EX Intracranial Support Catheter |
MicroVention, Inc. |
Miranda Beach |
K223085 |
09/29/2023 |
Miris Human Milk Analyzer (HMA) |
Miris AB |
Elin Hallen |
K232154 |
09/11/2023 |
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation |
MiRus, LLC |
Jordan Bauman |
K222948 |
09/19/2023 |
Q Distal Access Catheter |
MIVI Neuroscience, Inc |
Srija Reddy Bandari |
K231884 |
09/01/2023 |
TRIOCLEAR System |
Modern Dental Laboratory (DG) Co., Ltd. |
Robin Liu |
K232508 |
09/15/2023 |
Barrier EasyWarm Active Self-Warming Blanket |
Molnlycke Health Care US, LLC |
Megan Bevill |
K232146 |
09/14/2023 |
Anovo Pedestal |
Momentis Surgical Ltd. |
Maya Leib Shlomo |
K230767 |
09/21/2023 |
Pelvic Floor Muscle Stimulator |
Nanjing Vishee Medical Technology Co., Ltd. |
Qiu Kai |
K223575 |
09/06/2023 |
Phoenix ICON, Phoenix ICON GO |
NeoLight, LLC |
Amy Oakes |
K232558 |
09/22/2023 |
UroLift 2 ATC Advanced Tissue Control System |
NeoTract, Inc. |
Kelsey Krische |
K230067 |
09/22/2023 |
Para-Fix External Fixation System |
New Paradigm Biomedical |
John Wixted |
K232530 |
09/18/2023 |
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System |
Nexus Spine, LLC |
Jared Crocker |
K232121 |
09/15/2023 |
Power wheelchair (Model:BC-EA8000) |
Ningbo Baichen Medical Devices Co., Ltd. |
Wu Xiao Long |
K221900 |
09/29/2023 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Sharvari Nayak |
K230372 |
09/08/2023 |
VitreJect Syringe |
OcuJect, LLC |
Leonid Lerner |
K230959 |
09/14/2023 |
VitreJect« Needle; OcuSafe« Needle |
OcuJect, LLC |
Leonid Lerner |
K231284 |
09/08/2023 |
OnPoint Augmented Reality Spine System |
OnPoint Surgical, Inc. |
Amy ODonnell |
K221197 |
09/05/2023 |
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack |
Ortho Clinical Diagnostics |
Declan Hynes |
K231270 |
09/01/2023 |
Montage Flowable Settable, Resorbable Bone Paste |
Orthocon, Inc. |
Aniq Darr |
K230252 |
09/26/2023 |
OFIX MIS App |
Orthofix US LLC |
Shant Aghyarian |
K232315 |
09/15/2023 |
Catalyst Bone Void Filler |
OssDsign AB |
Jonas Aberg |
K230750 |
09/13/2023 |
OSSIOfiber« Cannulated Trimmable Fixation Nail |
Ossio Ltd. |
Taly Lindner |
K222778 |
09/23/2023 |
Osstem Implant System |
Osstem Implant CO., LTD. |
Seungju Kang |
K231079 |
09/14/2023 |
LW Retraction Cap |
Ossvis Co., Ltd. |
Young Jae Kim |
K231235 |
09/15/2023 |
LW UCLA Abutment |
Ossvis Co., Ltd. |
Young Jae Kim |
K230226 |
09/21/2023 |
Integrity-SI« Fusion System |
OsteoCentric Technologies |
Todd Evans |
K231702 |
09/29/2023 |
WiScope« Digital Cystoscope System, WiScope« Single-Use Digital Flexible Cystoscope, WiScope« Medical Tablet |
OTU Medical Inc. |
Geping Liu |
K231678 |
09/21/2023 |
Overjet Periapical Radiolucency Assist |
Overjet, Inc |
Deepthi Paknikar |
K232513 |
09/18/2023 |
X-Twist Biocomposite Suture Anchor |
Parcus Medical |
Calen Souther |
K230483 |
09/16/2023 |
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) |
Passy-Muir, Inc. |
Donna Malter |
K231802 |
09/19/2023 |
Millipede 088 Access Catheter |
Perfuze Ltd. |
Anne-Marie Gannon |
K232657 |
09/01/2023 |
InnerView LC |
Perimetrics, Inc |
Alicia Mszyca |
K232021 |
09/01/2023 |
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T |
Philips Healthcare (Suzhou) Co., Ltd. |
Li Sherry |
K231401 |
09/21/2023 |
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva |
Poly Medicure Limited |
Ramdas Sharma |
K221860 |
09/15/2023 |
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe |
Poonglim Pharmatech Inc. |
Hee Min Cho |
K230778 |
09/25/2023 |
EndoCore |
Praxis Medical, LLC |
John Fisher |
K222831 |
09/13/2023 |
CRYOcheck Factor VIII Deficient Plasma with VWF |
Precision BioLogic Inc. |
Karen Black |
K220735 |
09/15/2023 |
Avologi Gel Primer (Model: Av25) |
Premier North America Inc. |
Ellis Tamari |
K232166 |
09/08/2023 |
PreXion3D Expedition |
PreXion Corporation |
Kenji Tanaka |
K223496 |
09/26/2023 |
Inclusive« Titanium Abutments compatible with: Straumann« Bone Level SC, BioHorizons« Tapered Internal, MIS« C1 Implant Systems |
Prismatik Dentalcraft, Inc. |
So Hyun Park |
DEN220023 |
09/29/2023 |
Procise ADL |
ProciseDx Inc. |
Kurt Bray |
DEN210056 |
09/29/2023 |
Procise IFX |
ProciseDx Inc. |
Kurtis R. Bray |
K230692 |
09/20/2023 |
TULSA-PRO System |
Profound Medical Inc. |
Nicole Baker |
K232361 |
09/05/2023 |
Promaxo MRI System II |
Promaxo, Inc. |
Veronica Sanz |
K231792 |
09/28/2023 |
VeriSafe Safety sterile syringes |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
K231484 |
09/14/2023 |
PureWay 1.4 Quart Sharps Collector |
PureWay Compliance Inc. |
Jeffery Miglicco |
K223873 |
09/29/2023 |
Boppli Infant Blood Pressure Monitor |
PyrAmes Inc. |
Xina Quan |
K232255 |
09/27/2023 |
EZSensor XHD |
Qpix Solutions Inc. |
Seungman Yun |
K231149 |
09/22/2023 |
qXR-CTR |
Qure.ai Technologies |
Srinidhi Ragunathan |
K222938 |
09/12/2023 |
Ablation-fit |
R.A.W. Srl |
Chiara Ferrari |
K230890 |
09/08/2023 |
ISE Electrodes |
Randox Laboratories Ltd. |
Karena Shaw |
K231622 |
09/29/2023 |
REGER Nebulizer Irrigation Cannula |
REGER Medizintechnik, GmbH |
Christopher Kohn |
K222610 |
09/15/2023 |
Elecsys Anti-Tg |
Roche Diagnostics |
Phil Williams |
K221890 |
09/30/2023 |
Elecsys Tg II |
Roche Diagnostics |
Edie Eads |
K231385 |
09/20/2023 |
Rology Teleradiology Platform (v.1.22.1103) |
Rology Inc. |
Amr Abodraiaa |
K230193 |
09/21/2023 |
Servator P Plus SALF Solution |
S.A.L.F. spa |
Carmelo Gagliano |
K232650 |
09/29/2023 |
KHEIRON« Spinal Fixation System, including patient specific K-ROD |
S.M.A.I.O |
Jean-Charles Roussouly |
K223354 |
09/21/2023 |
EGIS Biliary Single Bare Stent |
S&G Biotech Inc. |
Sung-Kwon Kang |
DEN230006 |
09/06/2023 |
esolution |
S4 Medical Corp |
William Fuller |
K221508 |
09/29/2023 |
AnemoCheck Home |
Sanguina, Inc. |
Cathryn Cambria |
K223913 |
09/20/2023 |
Socrates Aspiration System |
Scientia Vascular Inc |
Thomas Lippert |
K231030 |
09/14/2023 |
Cove Putty, OsteoCove Putty |
SeaSpine Orthopedics Corporation |
Cindy Toyama |
K232668 |
09/27/2023 |
Cove Strip, OsteoCove Strip |
SeaSpine Orthopedics Corporation |
Cindy Toyama |
K230746 |
09/14/2023 |
Non absorbable Surgical Polypropylene Suture |
Shandong Haidike Medical Products Co.,Ltd. |
Yan Wang |
K231367 |
09/18/2023 |
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) |
Shenzhen Finicare Co., Ltd. |
Chao Li |
K232183 |
09/22/2023 |
IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 |
Shenzhen Koli Technology Co.,Ltd |
Qizhen Fu |
K230362 |
09/11/2023 |
Planar LED mate |
Shenzhen Leaflife Technology Co., Ltd |
Cheng Qiang |
K231800 |
09/07/2023 |
IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 |
Shenzhen Qianyu Technology Co., Ltd. |
Guoyang Li |
K230066 |
09/15/2023 |
Carnation series Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co., Ltd. |
Jiang Xiaosan |
K232124 |
09/14/2023 |
IPL Hair Removal, Model: W-1095, W-1098 |
Shenzhen Wochuan Electronic Co., Ltd |
Rebecca Jiang |
K231894 |
09/20/2023 |
LED Spectrum therapy instrument |
Shenzhenshi Sincoheren S&T Development Co.,Ltd. |
Zhongzhou Li |
K233161 |
09/28/2023 |
BeautiLink SA |
Shofu Dental Corporation |
Mauro Malzyner |
K213510 |
09/08/2023 |
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA |
Siemens Healthcare Diagnostics Products Ltd |
Stefani Vinkemeier |
K220265 |
09/24/2023 |
ADVIA Centaur« NT-proBNPII (PBNPII) |
Siemens Healthcare Diagnostics, Inc. |
Asha Gartland |
K223812 |
09/15/2023 |
Sensis Vibe (VD15) |
Siemens Medical Solutions USA Inc. |
Patricia D Jones |
K232482 |
09/06/2023 |
MAGNETOM Viato.Mobile |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
K232617 |
09/26/2023 |
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System |
Siemens Medical Solutions, USA, Inc |
Shilpa Rapaka |
K221309 |
09/19/2023 |
AI100 with Shonit |
SigTuple Technologies Pvt. Ltd. |
Tathagato Rai Dastidar |
K232978 |
09/22/2023 |
DX. Bond V Dental Bonding Adhesive |
Sino-Dentex Co., Ltd. |
Pengtao Yan |
K231188 |
09/28/2023 |
ALIGN Radial Head System |
Skeletal Dynamics Inc |
Alexandra Rodriguez Rojas |
K230825 |
09/25/2023 |
Smileyscope System (Therapy Mode) |
Smileyscope Holding Inc. |
Paul Leong |
K232457 |
09/08/2023 |
Q-FIX ULTRA All-Suture Anchor |
Smith & Nephew |
Catherine Phelan |
K231710 |
09/01/2023 |
OW100S |
Softwave./TRT LLC |
John Warlick |
K232459 |
09/12/2023 |
Velacur |
Sonic Incytes |
Barry Allen |
K230310 |
09/08/2023 |
STAT Medical Device Lancing System |
STAT Medical Devices |
Hemel Mariano |
K232485 |
09/13/2023 |
AMSCO 600 Steam Sterilizer |
Steris |
Anthony Piotrkowski |
K231746 |
09/11/2023 |
VERIFY Spore Test Strip for S40 Sterilant Concentrate |
Steris Corporation |
Gregory Land |
K231854 |
09/20/2023 |
1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM |
Stryker |
April Malmborg |
K230045 |
09/29/2023 |
HipCheck |
Stryker Corp. |
Lucas Dun |
K222823 |
09/07/2023 |
AeroDVx Arm System |
Sun Scientific Inc |
Allan Alward |
K230857 |
09/25/2023 |
TiLink-P SI Joint Fusion System |
Surgentec, LLC |
Andrew Shoup |
K231828 |
09/07/2023 |
PounceÖ Sheath |
Surmodics, Inc. |
Peter Bather |
K232647 |
09/29/2023 |
Microcatheter |
Surmodics. Inc. |
Jodie Christe |
K221869 |
09/05/2023 |
BCR-ABL1 (p210) % IS Kit (Digital PCR Method) |
Suzhou Sniper Medical Technologies Co., Ltd |
Peng Zhang |
K230167 |
09/14/2023 |
BACK 4 |
SWIMS America Corp |
Matthieu Commeau |
K231643 |
09/08/2023 |
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) |
Syntex Healthcare Products Co., Ltd. |
Qiao Zhiqiang |
K231336 |
09/15/2023 |
T2 Biothreat Panel |
T2 Biosystems, Inc. |
Rachel Gilbert |
K230187 |
09/29/2023 |
Terran NM-101 |
Terran Biosciences, Inc. |
Sam Clark |
K232414 |
09/08/2023 |
Klassic« Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post |
Total Joint Othopedics, Inc. |
Chris Weaber |
K230526 |
09/14/2023 |
TEA Device |
Transtimulation Research, Inc. |
Jieyun Yin |
K230946 |
09/15/2023 |
Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L |
Trax Surgical |
Steven Tallarida |
K230805 |
09/01/2023 |
TriMed Clavicle Fixation System |
TriMed, Inc. |
David Medoff |
K230049 |
09/07/2023 |
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING |
TTK Healthcare Limited |
Daniel J S |
K223848 |
09/08/2023 |
IntrisoundÖ Tuned Lumen« 155 Hearing Aids |
Tuned Ltd |
Orit lanco |
K232462 |
09/14/2023 |
ThermPix Thermovisual Camera |
USA Therm, Inc. |
Eric Heil |
K232400 |
09/08/2023 |
VariSeed (v10) |
Varian Medical Systems |
Lynn Allman |
K231317 |
09/12/2023 |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
Varian Medical Systems, Inc. |
Peter J. Coronado |
K232192 |
09/11/2023 |
Venus Versa PRO System |
Venus Concept Inc. |
William H. McGrail |
K231504 |
09/11/2023 |
TITANEXÖ MICROBEAM Screw System, TITANEXÖ ARTEMIS Screw System |
Vilex LLC |
Brock Johnson |
K232616 |
09/27/2023 |
Volta AF-Xplorer |
Volta Medical |
Paola Milpied |
K232167 |
09/27/2023 |
VySpanÖ PCT System |
Vy Spine, LLC |
Jordan Hendrickson |
K231076 |
09/27/2023 |
VariLift«-C Interbody Fusion System |
Wenzel Spine, Inc. |
William Wilson |
K231542 |
09/07/2023 |
Digital Blood Pressure Monitor WBP Series |
Weony (Shenzhen) Technology Co., Ltd. |
Autumn Liu |
K231727 |
09/08/2023 |
Sterile Auto-Disable Syringes with/without Needle for Single Use |
Wepon Medical Technology Co., Ltd. |
Di Zhao |
K231720 |
09/08/2023 |
Sterile Hypodermic Needles for Single Use |
Wepon Medical Technology Co., Ltd. |
Di Zhao |
K231723 |
09/08/2023 |
Sterile Safety Hypodermic Needles for Single Use |
Wepon Medical Technology Co., Ltd. |
Di Zhao |
K231729 |
09/08/2023 |
Sterile syringes for single use with/without needle |
Wepon Medical Technology CO., Ltd. |
Di Zhao |
K231999 |
09/07/2023 |
Steriking« LT-Blueline Pouches with Tyvek« |
Wipak OY |
Hanna Marttila |
K231996 |
09/07/2023 |
Steriking« LT-Blueline Pouches with Tyvek« |
Wipak OY |
Hanna Marttila |
DEN230007 |
09/01/2023 |
LightStrike+ (MXSUV1-SL and MXSUV1-FT) |
Xenex Disinfection Services, Inc. |
Juan L. Gonzalez |
K232193 |
09/22/2023 |
Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) |
Yurob Rehabilitation Medical Co.,Ltd. |
Pan Daoping |
K230661 |
09/08/2023 |
Zeta Cranial Navigation System |
Zeta Surgical |
Jose Amich |
K231471 |
09/08/2023 |
Air/Water Bottle Tubing, CO2 Source Tubing |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
K232199 |
09/15/2023 |
Bariatric Heavy Duty Wheelchair (YJ-010B 20ÆÆDS; YJ-010B 20ÆÆDE; YJ-010B 20ÆÆDFS; YJ-010B 20ÆÆDFE;YJ-010B 20ÆÆADS; YJ-010B 20ÆÆADE; YJ-010B 20ÆÆADFS; YJ-010B 20ÆÆADFE; YJ-010B 22ÆÆDS; YJ-010B 22ÆÆDE; YJ-010B 22ÆÆDFS;YJ-010B 22ÆÆDFE; YJ-010B 22ÆÆADS;YJ-010 |
Zhenjiang Assure Medical Equipment Co., Ltd. |
Ying Mei |
K232198 |
09/15/2023 |
Reclining wheelchair (YJ-011S 16öD, YJ-011S 16öDF, YJ-011S 18öD, YJ-011S 18öDF, YJ-011S 20öD, YJ-011S 20öDF) |
Zhenjiang Assure Medical Equipment Co., Ltd. |
Ying Mei |
K232691 |
09/05/2023 |
Polibond |
Zirkonzahn Srl |
Sorana Siclovan |
K231013 |
09/28/2023 |
DNA/RNA Shield SafeCollect Saliva Collection kit |
Zymo Research |
Julie Ogi |