FDA 510(k) clearances — page 100
clearances on record, most recent first.
Clearances — page 100
9,901–10,000 of 176,479- K232064 — Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
- K232359 — Surgical face mask
- K221890 — Elecsys Tg II
- DEN210011 — Invitae Common Hereditary Cancers Panel
- DEN210056 — Procise IFX
- DEN220023 — Procise ADL
- K212769 — DYNEX SmartPLEX MMRV IgG Assay Kit
- K213403 — Aptiva CTD Essential Reagent
- K220458 — UltraFlo-R Push Button Blood Collection Set
- K221274 — StarFormer, TightWave
- K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
- K221508 — AnemoCheck Home
- K221570 — Antibacterial bandage
- K221900 — Stat Profile Prime Plus Analyzer System
- K223085 — Miris Human Milk Analyzer (HMA)
- K223873 — Boppli Infant Blood Pressure Monitor
- K230045 — HipCheck
- K230187 — Terran NM-101
- K230591 — TriLEAP Plating System
- K230847 — Chemotherapy Gloves
- K231527 — TriALTIS Navigation Enabled Instruments
- K231622 — REGER Nebulizer Irrigation Cannula
- K231628 — BeShape One Device
- K231649 — Intraosseous Fusion Device System
- K231702 — WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
- K231957 — SafeBreak® Vascular
- K231973 — PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
- K232299 — CeraPutty
- K232647 — Microcatheter
- K232650 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K232651 — BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter
- K232669 — TBI
- K232690 — Amulet Steerable Delivery Sheath
- K232701 — Guardenia (GAR-1)
- K233257 — 3M ClarityAligners with Quick Attachments
- K230865 — PIVO Pro Needle-free Blood Collection Device
- K231013 — DNA/RNA Shield SafeCollect Saliva Collection kit
- K231188 — ALIGN Radial Head System
- K231792 — VeriSafe Safety sterile syringes
- K231837 — Brainomix 360 Triage LVO
- K231901 — Hakon, Hakon Smart
- K232274 — IPL hair removal device
- K232605 — Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
- K232699 — Low Ejection Fraction AI-ECG Algorithm
- K233161 — BeautiLink SA
- K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
- K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
- K230563 — EVOLUTION® Hinge Knee System
- K230925 — Disposable Injection Needle AF series
- K231007 — CEDIA Heroin Metabolite (6-AM) Assay
- K231076 — VariLift®-C Interbody Fusion System
- K231108 — Talon Transseptal Sheath
- K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
- K231538 — FreedomFlow Orbital Circumferential Atherectomy System
- K232167 — VySpan PCT System
- K232255 — EZSensor XHD
- K232260 — Thinline Sheath Introducer
- K232275 — Invictus® Spinal Fixation System
- K232596 — EndoGI S-Path Biliary Stent System
- K232609 — Micro Ace Advanced Micro Access System
- K232616 — Volta AF-Xplorer
- K232668 — Cove Strip, OsteoCove Strip
- DEN220026 — VasQ
- K213517 — Access Thyroglobulin Antibody II
- K220396 — EasyStat 300
- K223496 — Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems
- K230252 — OFIX MIS App
- K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
- K230513 — Arthrex Univers Apex OptiFit Humeral Stem
- K230884 — AVVIGO'+ Multi-Modality Guidance System
- K231971 — DEKA PHYSIQ 360
- K232233 — Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
- K232336 — ES Series V2
- K232617 — ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
- K221052 — Self-Fitting hearing aids
- K223933 — Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
- K230184 — Holter ECG and ABP System
- K230778 — EndoCore
- K230825 — Smileyscope System (Therapy Mode)
- K230857 — TiLink-P SI Joint Fusion System
- K231739 — Cervical Spine Truss System (CSTS)
- K231888 — BD Texium Needle-Free Syringe
- K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
- K231928 — EFAI RTSUITE CT HCAP-Segmentation System
- K231977 — PEACH 2, PEACH 2 Duo, PEACH 2 go
- K232097 — IdentiTi ALIF Interbody Systems
- K220265 — ADVIA Centaur® NT-proBNPII (PBNPII)
- K222778 — Osstem Implant System
- K223919 — B.Light Clear Evo and B.Light Restore Evo
- K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
- K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer
- K223659 — Jazz
- K223921 — Access CEA
- K230067 — Para-Fix External Fixation System
- K230350 — VISULAS yag
- K230980 — MicroMatrix® Flex
- K231092 — T-SHAPE 2
- K231149 — qXR-CTR
- K231239 — Nexiva Closed IV Catheter System with NearPort IV Access
- K231384 — Annalise Enterprise CTB Triage Trauma
Data sourced from openFDA. This site is unofficial and independent of the FDA.