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FDA Tracker

Every surgical 510(k), the day FDA posts it.

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Ablation Catheter Surgical Imaging Diagnostic All medical devices

All classes Class I Class II Class III100 entries · live · openFDA

510(k)

Sponsor

Device

Class

Cleared

Hindernis DE Mexico, S.A.P.I. DE C.V.

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

Zumax Medical Co., Ltd.

Surgical Microscope (OMS2360, OMS2380)

Cardinal Health 200, LLC

Cardinal Health Poly Reinforced Surgical Gown

Hubei Xinxin Non-Woven Co., Ltd.

Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)

Strauss Surgical USA

Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,

Foundation Surgical Group, Inc.

Foundation Surgical Navigated Lateral Disc Prep Instruments

American Medical Endoscopy, Inc.

Strauss Surgical cystoscope, hysteroscope and accessories Instruments

Restore Robotics

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)

Adeor Medical AG

Velocity Alpha MR High Speed Surgical Drill System

Zhejiang Hangkang Medical Equipment Co., Ltd.

Surgical Face Mask (Ear mount)

Copioumed International, Inc.

Copioumed AAMI 3 Surgical Gown

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

Medtronic Navigation, Inc.

Stealth AXiS Surgical System with Stealth AXiS Spine clinical application

MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture

Dentsply Sirona, Inc.

Stainless Steel Surgical Kits

Yadu Medical (Henan) Co., Ltd.

Henan Yadu Level 4 Surgical Gowns (Reinforced)

Surgical Reality Viewer

Point Robotics MedTech, Inc.

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

Intuitive Surgical, Inc.

da Vinci Surgical System (IS5000)

Intuitive Surgical, Inc.

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator

Beatles Medical Supplies (Xiantao) Co., Ltd.

Disposable Surgical Face Mask (3P00B, C2900)

Precision AI Pty, Ltd.

Precision AI Surgical Planning System (PAI-SPS)

Merit Medical Systems, Inc.

SCOUT MD Surgical Guidance System

Cmr Surgical Limited

Versius Surgical System (Versius Plus)

Intuitive Surgical, Inc.

da Vinci SP Surgical System (SP1098)

Yadu Medical (Henan) Co., Ltd.

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

Intuitive Surgical, Inc.

da Vinci SP Surgical System (SP1098)

Remington Medical, Inc.

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

Medical Microinstruments, Inc.

Symani Surgical System

Primed Medical Products, Inc.

PRIMED Surgical and Procedure Masks

Feeltech Co., Ltd.

V-soft Line Barbed Surgical Suture (Various)

Revolve Surgical, Inc.

Revolve Surgical System

Internacional Farmacéutica S.A DE C.V

PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)

Intuitive Surgical, Inc.

da Vinci SP Surgical System (SP1098)

Levita Magnetics International Corp

Magnetic Surgical System

Intuitive Surgical, Inc.

da Vinci SP Surgical System (SP1098)

Intuitive Surgical, Inc.

da Vinci Surgical System (IS5000)

Medical Microinstruments, Inc.

Symani Surgical System

Intuitive Surgical, Inc.

da Vinci SP Surgical System (SP1098)

Agnes Medical Co., Ltd.

Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)

Outlook Surgical Versa One System (8900139)

American Medical Endoscopy, Inc.

Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo

Intuitive Surgical, Inc.

da Vinci Surgical System, IS5000

Intuitive Surgical, Inc.

Da Vinci Surgical System (IS5000)

Dentsply Sirona, Inc.

Plastic Surgical Kits

Talladium España, SL

Guided DAS Surgical Kit

Excite Medical of Tampa Bay, LLC

True Non-Surgical Spinal Decompression System (DRX9000-SL)

Intuitive Surgical, Inc.

da Vinci Surgical System (IS5000)

Momentis Surgical , Ltd.

Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode

Hypervision Surgical

HyperSnap Surgical System (HSS)

Winner Medical Co., Ltd.

Procedure mask/Surgical mask/Face mask

Intuitive Surgical, Inc.

da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)

Levita Magnetics International Corp

Magnetic Surgical System

Momentis Surgical , Ltd.

Anovo Surgical System (6Ne)

Owens & Minor (O&M) Halyard, Inc.

Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce

Brain Navi Biotechnology Co., Ltd.

Stereotaxic Guiding Surgical Devices, NaoTrac S

Dae Myung Chemical Co., Ltd. (Vietnam)

Dream Medi Sterile Surgical Gown (SurgicalGownUL)

Intuitive Surgical, Inc.

da Vinci SP Surgical System (SP1098)

LEM Surgical AG

Dynamis Robotic Surgical System

Turbett Surgical

Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)

Intuitive Surgical, Inc.

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)

Prismatik Dentalcraft, Inc.

Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit)

Kico Knee Innovation Company Pty Limited

ARVIS Surgical Navigation System

Medline Industries, LP

Medline Level 4 Surgical Gown with Breathable Sleeves

New World Medical, Inc.

VIA360 Surgical System

Wontech Co., Ltd.

WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)

Infinitum Eta, Ltd.

NUVENTUS NV.C Surgical Cassette and Tray

Medical Microinstruments, Inc.

Symani Surgical System

Medical Microinstruments, Inc.

Symani Surgical System (820-03830)

Precision AI Pty, Ltd.

Precision AI Surgical Planning System (PAI-SPS)

Light Guide Optics International , Ltd.

LGO-Surgical Laser Fibers

Freudenberg Medical, LLC

FirstFit Surgical Kit

Intuitive Surgical, Inc.

da Vinci Surgical System (IS5000)

Navbit Pty, Ltd.

Rapid Surgical Plan (RSP-SW-001)

Supermax Healthcare Canada Supermax Medical

Aurelia Surgical Mask ASTM Level-3 (2130)

Wright Medical Technology, Inc. (Stryker)

Prophecy Surgical Planning System

Momentis Surgical , Ltd.

Anovo Surgical System (Model 6Ne)

Xiantao Daoqi Plastic Co., Ltd.

Surgical Face Mask (Tie on/ Ear loops)

Stryker Instruments

Stryker Steri-Shield 8 Surgical Hoods and Togas

Momentis Surgical , Ltd.

Anovo Surgical System (model 6N)

Saeshin Precision Co., Ltd.

Traus SSG10 Surgical System

Saeshin Precision Co., Ltd.

Traus SSG30 Surgical System

Standard Textile Co., Inc.

ProPel SG3 Surgical Gown

Prestige Ameritech

ProGear® Surgical Mask with Oxafence®, Model AV82030

Remington Medical, Inc.

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)

Primed Medical Products, Inc.

PRIMED Surgical Masks and PRIMED Procedure Masks

Precision AI Pty, Ltd.

Precision AI Surgical Planning System (PAI-SPS)

George Courey, Inc.

GCI Surgical Gown

Guangdong Kingfa Sci. & Tech.Co., Ltd.

Medical surgical mask

Asensus Surgical, Inc.

Senhance Surgical System

Guangdong Jinme Medical Technology Co., Ltd.

Surgical Drive System (Model: ES70, ES90, E8)

Peters Surgical

Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)

Intuitive Surgical, Inc.

da Vinci Surgical System (IS5000)

Owens & Minor (O&M) Halyard, Inc.

FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)

Oertli Instrumente AG

Faros Surgical System

Owens & Minor (O&M) Halyard, Inc.

Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)

Owens & Minor (O&M) Halyard, Inc.

Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)

Owens & Minor (O&M) Halyard, Inc.

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)

Intuitive Surgical, Inc.

da Vinci SP Surgical System (SP1098)

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