FDA 510(k) clearances — page 84
clearances on record, most recent first.
Clearances — page 84
8,301–8,400 of 176,479- K240601 — SnapshotNIR model KD205
- K240888 — Calibra Abutment Resin Cement
- K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,
- K232726 — External Hex Implant System
- K233133 — Talis EMR with Talis +ACG (Talis EMR with +ACG)
- K233676 — Us2.v2
- K233990 — Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
- K240043 — EVOLUTION® Hinge Knee System +13 more
- K240288 — SF Push- in Anchor
- K240397 — AlphaVac MMA F1885 System (H787253020)
- K240442 — MagnetOs Putty
- K240635 — ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm
- K231209 — Rejoyn
- K211122 — Novum IQ Large Volume Pump
- K230665 — Dose IQ Safety Software
- K232018 — Citrated: K, KH, RTH, FFH
- K232031 — LUNA 3D
- K232825 — Disposable Sphincterotome
- K233068 — Disposable Surgical Gown
- K233211 — AVIEW CAC
- K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation
- K233622 — AlignRT Plus
- K240310 — LCD Monitors C310S, G310S, C316S, G316S, C616W
- K240587 — SmoothSkin Pure Unplugged (SSB3)
- K240608 — MAGNETOM Viato.Mobile
- K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft
- K232013 — Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
- K232047 — VIVACE
- K232049 — IS-III active Short Implant
- K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more
- K233409 — Eko Low Ejection Fraction Tool (ELEFT)
- K233604 — BTL-785S
- K233609 — CORE 500 Digital Stethoscope
- K233657 — NAEOTOM Alpha
- K233669 — OEC 3D
- K233719 — FDR Visionary Suite
- K233838 — Emprint Ablation System with Thermosphere Technology (Overall System Name) +9 more
- K233909 — Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister
- K240171 — ProSeal Injector Plus (Model no. 421050)
- K240284 — Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)
- K240295 — InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)
- K240567 — CustomizedBone Service
- K240693 — LINQ II Insertable Cardiac Monitor (ICM)
- DEN210049 — Medline ART Skin Harvesting System
- K222613 — ARX Liquid Amies Collection & Transport System
- K223360 — LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
- K231425 — Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
- K232253 — Modius Stress
- K232891 — CARPL (CARPL)
- K233201 — MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)
- K233539 — MAMMOMAT B.brilliant
- K233951 — CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
- K233989 — CarboClear® Posterior Cervical Screw System
- K234097 — Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K234143 — i-STAT TBI Cartridge with the i-STAT Alinity System
- K234150 — Lucent® XP
- K240045 — QStat Cartridge
- K240389 — Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ) +1 more
- K231132 — J & P Click Attachments
- K231793 — RODIN 3D Resin SPLINT, Hard/Flex
- K231984 — Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
- K232954 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
- K233069 — Removal System Large Bore 60 cc Syringe
- K233151 — PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
- K233611 — SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
- K233650 — SOMATOM go.Up +7 more
- K233733 — SyMRI
- K240594 — Grappler Suture Anchor R3FLEX IOL System
- K231986 — Modus IR
- K232268 — STERI-OSS Implant System
- K233167 — LW Implant System Abutment
- K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) +2 more
- K233919 — VariAx 2 Distal Radius System
- K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
- K234085 — LUNE PureHygiene
- K240292 — Transcutaneous Electrical Nerve Stimulator (9029SCM)
- K240329 — Electric wheelchair (YHW001-C; YHW001-D; YHW001-E; YHW001-F)
- K240589 — Micropuncture Introducer Sets; Micropuncture Pedal Access Sets
- K240620 — Cube Navigator
- DEN230034 — X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
- K231795 — QuickVue COVID-19 Test
- K231806 — Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
- K231926 — NeuroStar Advanced Therapy System (All previously cleared models)
- K231927 — Elecsys PTH , Elecsys PTH STAT
- K231930 — Digital Ultrasonic Diagnostic Imaging System (Model: F6)
- K231938 — Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid +2 more
- K231953 — Biatain Fiber Ag (5 models)
- K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector
- K232169 — FITBONE® Transport and Lengthening System
- K232282 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device
- K232322 — MAGNETOM Terra; MAGNETOM Terra.X
- K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
- K232431 — syngo.CT Brain Hemorrhage
- K232548 — Corsano CardioWatch 287-2 System
- K232920 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
- K233148 — Augment Off-Axis Instrument System
- K233262 — Dukal SMS Sterilization Wrap
- K233441 — The Vest APX System (PVAPX1)
- K233569 — SeptAlign
- K233578 — BAHADIR STERILIZATION CONTAINERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.