FDA 510(k) clearances — page 79
clearances on record, most recent first.
Clearances — page 79
7,801–7,900 of 175,620- K240173 — Treace Medical Systems (TMC) Plating System
- K240174 — 1688 4K Camera System with Advanced Imaging Modality
- K240193 — R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)
- K240313 — Oligio X
- DEN230064 — BraidE Embolization Assist Device
- K231561 — Pulmonary Function Tester, Model: A9
- K231753 — Oneday Implant Abutment
- K232148 — X-Guide Surgical Navigation System
- K232265 — BLUEPRINT Patient Specific Instrumentation
- K232502 — Cocoon Convective Warming System, Model CWS7000
- K233199 — ROSA® Shoulder System
- K233325 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
- K233439 — HD60 Series Ultrasound Diagnostic System
- K240194 — ProCinch, QuadCinch
- K231896 — Diode Laser Therapy System
- K233150 — NET BRAND Osteosynthesis Nailing System
- K233194 — TS Abutment System
- K233454 — ONLINE TDM Methotrexate
- K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)
- K233760 — Mjolnir Pro. (Multielectrode plasma)
- K240146 — BD Prevue II Peripheral Vascular Access System
- K230235 — Medline Luer Lock Syringes
- K231453 — SnapHammer Hammertoe Correction System
- K231513 — Oral Matrix
- K231657 — AGILON® XO Shoulder Replacement System
- K231985 — Disposable Grounding Pad
- K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
- K232087 — Dental LT Comfort Resin
- K232420 — Zenition 30
- K232645 — Airgle Room Air Purifier
- K232771 — Montage Flowable Settable, Resorbable Bone Paste
- K233652 — Contour Hand/Wrist (Q7000232)
- K233658 — Biowy Tym Tube (TT)
- K233708 — NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
- K233906 — S-Patch (S-Patch ExL)
- K234005 — Access CK-MB
- K240119 — VasQ
- K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
- K240148 — SCIg60 Infusion System
- K222917 — Breathing circuit bacterial/viral filter
- K223493 — PBC Separator with Selux AST System
- K231107 — Bronchoscope System
- K231522 — EMPHASYS Dual Mobility System
- K231659 — MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)
- K232245 — VedDilator ^TM (3-Stage Balloon Dilation Catheter)
- K232915 — EpiMonitor
- K233483 — FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
- K233656 — Contour Shoulder
- K234028 — COPAL® exchange G hip spacer; COPAL® G+V
- K234036 — SONIK MONARK 100
- K240130 — Medical Monitor (21HQ613D)
- K240157 — InVision 1.5 Surgical Theatre
- K231514 — Azure
- K233678 — Radiography 7000 M
- K240427 — airVata
- K231134 — VerteLoc Spinal System
- K231855 — QOCA® image Smart RT Contouring System
- K231990 — Apex Locator
- K232082 — EXPD 4343S
- K233661 — Transorb Self-Gripping Resorbable Mesh
- K233740 — Black Nitrile Powder Free Patient Examination Glove, Non Sterile
- K233788 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K233954 — Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
- K233959 — EPi-Ease Epicardial Access Device (EAS)
- K234048 — M.U.S.T. Pedicle Screw System - Extension
- K234123 — Easi-Vue® embolic microspheres System
- K231468 — SCOUT MD Surgical Guidance System
- K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope
- K232674 — PainFreeze II
- K233040 — EMS/TENS Massager Device
- K233092 — Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
- K233134 — I.T.S. INS Proximal Femur Nail
- K233217 — Mimics Cardiac Planner
- K233260 — Univers Revers CA Head and Adapter
- K233401 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
- K233533 — NerveTape
- K233635 — SPY Cystoscope/Hysteroscope
- K233667 — Facial Toning device (UIC-189); Facial Toning device (UIC-589)
- K231355 — Aurora
- K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor
- K232072 — AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G
- K232473 — Infrared Thermometer: Model YJ600
- K233464 — WSA Self-Fitting Hearing Aid Gen 2
- K233631 — ZapStim Controller Application (Z1023)
- K233638 — VERZA High Speed Drills
- K234034 — VenaCore Thrombectomy Catheter (46-101)
- K234037 — CATS-L Tonometer Prism
- K240066 — Fine Osteotomy
- K240072 — Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
- K240084 — V-STRUT® Vertebral Implant
- K240098 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
- K230839 — Concentriq Dx
- K231536 — eQUANT System
- K231575 — Vecttor VT-300
- K231662 — Aid-U
- K231913 — T-FIT
- K232644 — neuro42 MRI System
- K232854 — Leksell GammaPlan (LGP)
- K233024 — Alma Harmony
- K233080 — HealthFLD
Data sourced from openFDA. This site is unofficial and independent of the FDA.