FDA 510(k) clearances — page 92
clearances on record, most recent first.
Clearances — page 92
9,101–9,200 of 176,479- K233741 — Hoffmann LRF System
- K233813 — Bearing nsPVA Express
- K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
- K223585 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear
- K230545 — Inessa System
- K230736 — MagnetOs Putty
- K230850 — United Orthopedic Knee Patient Specific Instrumentation
- K230855 — BD Vacutainer® Serum Separator (SST) Blood Collection Tubes
- K230955 — syngo Application Software
- K231227 — SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
- K231354 — Pocket Ultrasound System (C10)
- K231402 — HP PTA Balloon Dilatation Catheter
- K231411 — INNO SLA Submerged Hybrid Ti-Base System
- K231556 — SPECTRUM® GV Bone Cement
- K231660 — Digital image scanner of dental
- K231780 — Perifit Care+
- K231968 — Tactoset® Injectable Bone Substitute
- K232017 — ARK Methotrexate II Assay
- K232048 — Cogent Hemodynamic Monitoring System; Cogent HMS
- K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- K232444 — Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
- K232736 — Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test
- K232992 — 10THERMA
- K233017 — TM Plating System
- K233130 — Blood Pressure Monitor
- K233176 — uOmnispace.MI
- K233492 — EMS Neck Massager
- K233782 — SmoothSkin Pure Adapt (SSG3)
- K233839 — Peridot-PT Anterior Cervical Intervertebral body fusion System +3 more
- K221199 — Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)
- K222810 — TD-7301 Peak Flow meter
- K230840 — PMT Facet Fixation System, Lumbar (PMT FFS-LX)
- K231526 — CORAIL Cemented Femoral Stem
- K231671 — IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
- K232458 — JETiHydrodynamic Thrombectomy System
- K232560 — Angled Abutment
- K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
- K233163 — ZENEX Implant System_Short
- K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
- K233470 — DEKA LILY
- K233551 — GORE® ACUSEAL Vascular Graft
- K222846 — AMT G-Tube Balloon Gastrostomy Feeding Device
- K222881 — Access hsTnI
- K231066 — CuratOR EX3242-FD
- K231429 — S-Plant Dental Implant System
- K231587 — MAGNETOM Cima.X
- K231929 — iQ-solutions
- K232780 — CC-Clip® Implant System
- K232847 — SiOxD Wound Matrix
- K232984 — Ion Endoluminal System (IF1000)
- K233815 — ClotTriever Sheath
- K233691 — FlexCath Cross Transseptal Solution
- K233536 — Air Compression Recovery System
- DEN230050 — Body Temperature Software (BTS)
- K223721 — Masimo Stork
- K230501 — Spirobank Oxi
- K230751 — EW10-EC02 Endoscopy Support Program
- K230926 — Ova+ (K-OVAP-USA)
- K230949 — ARTIS pheno (VE30A)
- K231160 — Cardio Q50, Cardio Q70
- K231447 — Double Internal Joint Stabilizer- Elbow
- K231478 — Digital Blood Pressure Monitor (Model: YB-800)
- K231700 — Ziehm Vision FD
- K231825 — Panther TPS
- K232095 — SeptiCyte RAPID
- K232130 — Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
- K232267 — Precice Max System
- K232384 — Videa Dental Assist
- K232394 — Internal Locking Plate and Screw Fixation System
- K232598 — Unscented Menstrual Tampon
- K232887 — Invisalign Palatal Expander System
- K232892 — Hp Detect Stool Antigen ELISA
- K232939 — IPL Hair Removal Device
- K232957 — Sterile and Non-Sterile Ultrasound Gels
- K233182 — Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
- K233237 — xeo+ Family
- K233564 — FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)
- K233607 — MagnetOs Easypack Putty
- K233668 — Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)
- K233681 — ConFirm 20 Minute Incubator
- K233682 — VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
- K223470 — C50
- K230950 — ARTIS icono (VE30A)
- K231181 — bright CT
- K231570 — StrokeViewer Perfusion
- K231645 — PherDal® At-Home Insemination Kit
- K231721 — Disposable Hot Biopsy Forceps
- K231801 — MedHealth DVT compression Devices MHH900S/MHH900E
- K231887 — ARIX Ankle Distal Tibia System
- K232283 — PhySoftAMS®
- K232401 — Disposable Veress Needles
- K232455 — SofWave System
- K232580 — Disposable Endobronchial Blocker Tube
- K232875 — Vial Adapter 20mm
- K233227 — VELYS Robotic-Assisted Solution
- K233374 — Secret Pro
- K233647 — VersaCross Connect Transseptal Dilator
- K233648 — Millipede 088 Access Catheter
- K233670 — Ascension Silicone MCP; Ascension Silicone PIP
- K230742 — ACCLARENT AERA Eustachian Tube Dilation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.