FDA 510(k) clearances — page 75
clearances on record, most recent first.
Clearances — page 75
7,401–7,500 of 175,620- K233249 — APPRAISE-HRI
- K233666 — CorVista System with PH Add-On
- K233779 — LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
- K233935 — DigiLine Direct Print Aligner System
- K234105 — Catalyst F1x Shoulder System
- K234152 — ACESO Early Pregnancy Test
- K240360 — Wrinkle Treatment Device (JM2)
- K240647 — Virage® Navigation System
- K240737 — G Surgical Marksman MIS System
- K231834 — VSP PEEK Cranial Implant
- K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
- K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
- K232114 — TRIBRID® Unicompartmental Knee System
- K232227 — ABLATE-IQ
- K232790 — KONG®-TL VBR System and KONG® C VBR System
- K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
- K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
- K233837 — Agile Esophageal Stent System
- K233910 — Vertex Hip Fracture Nailing System
- K240038 — Clear Moves Aligners
- K240071 — Peleton Universal Single Use Power System and Attachments
- K240172 — Preview Shoulder
- K240361 — Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)
- K240639 — PINNACLETM Constrained Acetabular Liners
- K240652 — Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
- K230889 — Digital Thermometer
- K232653 — Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
- K232899 — AI-Rad Companion Organs RT
- K233548 — Uresta®
- K233618 — Oxevision Sleep Device
- K240135 — Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)
- K240282 — IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
- K240350 — AnyPlus II Spinal Fixation System
- K240618 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens
- DEN230036 — Sepsis ImmunoScore
- K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
- K232112 — R&G Surgical Mask
- K232835 — Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
- K233750 — ECG-less Cardiac
- K233975 — Zoom 6F Insert Catheters
- K240080 — Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- 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;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
- 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); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
- 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); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B)
- 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 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)
- K231132 — J & P Click Attachments
Data sourced from openFDA. This site is unofficial and independent of the FDA.