FDA 510(k) clearances — page 83
clearances on record, most recent first.
Clearances — page 83
8,201–8,300 of 175,620- K232535 — MAGNETOM Sola; MAGNETOM Altea
- K232717 — Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
- K232789 — VIO System (V-1000)
- K232881 — Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
- K233027 — NanoZoomer S360MD Slide scanner system
- K233058 — VivaChek Link Plus Blood Glucose Monitoring System
- K233082 — TopCEM Dual Cure Resin Cement
- K233104 — SofWave System
- K233109 — TP Pivot Pro Needle Guide
- K233205 — Distal Access Catheter
- K233264 — Anthogyr INTEGRAL Guided Surgery Cassettes
- K233304 — Omnimax S3, Omnimax S4
- K233734 — Interson USB Ultrasound System
- K233742 — CloudTMS Edge for OCD
- K234043 — 3M Transbond Orthodontic Adhesive
- K221753 — Kangbeier Child Surgical Mask
- K223359 — LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
- K223729 — FLOWpresso
- K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
- K231027 — KaiBiLi Extended ViralTrans
- K231099 — SMR Hybrid Glenoid System
- K231307 — Elos Accurate Customized Abutment
- K231531 — Pediarity
- K231889 — Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
- K232320 — iSR`obot Mona Lisa 2.0
- K232329 — Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
- K232579 — Twoplus Applicator
- K232744 — syngo Virtual Cockpit (VB10A)
- K232784 — RELiZORB®
- K232870 — TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)
- K232888 — Disposable Laryngeal Electrodes
- K232944 — CALLISTO eye
- K233016 — Dental Glass Ceramics
- K233018 — PICOSECOND Nd:YAG Laser System
- K233112 — HM70 EVO Diagnostic Ultrasound System
- K233154 — SkyOPS Orthopedic Plate System
- K233276 — Reusable Blood Pressure Cuff
- K233396 — Cannulated Screw System
- K233423 — Tyber Medical Anatomical Plating System Line extension to the Mini-Frag System
- K233465 — RadiForce MX317W
- K233498 — Stryker Orthopaedics Hip Systems Labeling Update
- 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; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.