FDA 510(k) clearances — page 92
clearances on record, most recent first.
Clearances — page 92
9,101–9,200 of 175,620- 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
- K231446 — Single-Use Latex Sterile Surgical Gloves (SG100)
- K231479 — TriALTIS Spine System
- K231730 — FemaSeed Intratubal Insemination
- K231767 — Annalise Enterprise CTB Triage Trauma
- K232183 — IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
- K232193 — Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)
- K232224 — iLet® Dosing Decision Software
- K232558 — UroLift 2 ATC Advanced Tissue Control System
- K232571 — CATHTONG II PICC Catheter
- K232594 — CATHTONG II PICC Catheter
- K232978 — DX. Bond V Dental Bonding Adhesive
- K223214 — Powder-Free Nitrile Examination Gloves
- K223354 — EGIS Biliary Single Bare Stent
- K230102 — Smart double sides wearable breast pump, Electric bilateral breast pump
- K230193 — Servator P Plus SALF Solution
- K230226 — Integrity-SI® Fusion System
- K230467 — BTL-899F
- K230767 — Pelvic Floor Muscle Stimulator
- K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
- K231401 — Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
- K231678 — Overjet Periapical Radiolucency Assist
- K232159 — QEVO System
- K232569 — CAREMIBRAIN
- K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
- K223179 — Cholestech LDX System
- K223421 — MedCAD AccuPlan Orthopedics System
- K223913 — Socrates Aspiration System
- K230011 — Mpact Extension
- K230043 — Insulin Pen Needle
- K230239 — AirSeal iFS System; AirSeal dV Solution
- K230692 — TULSA-PRO System
- K231342 — Insufflator (OPTO-IFL1000)
- K231385 — Rology Teleradiology Platform (v.1.22.1103)
- K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
- K231894 — LED Spectrum therapy instrument
- K232556 — DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
- K232582 — Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
- K232583 — Catalyst R1 Reverse Shoulder System
- K232592 — CITRELOCK® DUO
- K221309 — AI100 with Shonit
- K222948 — Q Distal Access Catheter
- K230966 — angiOCCLUDE Ligating Clips
- K231106 — Accuject Refra Injector AR2900
- K231281 — Aquilion Serve (TSX-307A/1) V1.3
- K231802 — Millipede 088 Access Catheter
- K232178 — GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
- K222251 — B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC
- K223835 — MA-40, MA-112
- K231367 — Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
- K231663 — The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
- K231832 — Access Myoglobin
- K232172 — BTL-785BNF Handpiece
- K232513 — X-Twist Biocomposite Suture Anchor
- K232530 — Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
- K232544 — Apollo ESG NXT System, Apollo REVISE NXT System
- K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
- K231688 — ImPACT Version 4
- K220735 — Avologi Gel Primer (Model: Av25)
- K220972 — Access Thyroglobulin
Data sourced from openFDA. This site is unofficial and independent of the FDA.