FDA 510(k) clearances — page 58
clearances on record, most recent first.
Clearances — page 58
5,701–5,800 of 175,620- K242157 — Anovo Surgical System (Model 6Ne)
- K242266 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
- K242554 — Arthrex VAL and VAL KreuLock Compression Screw System
- K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
- K232994 — Vittra APS Unique Flow
- K233054 — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
- K233378 — ABCcolla® Collagen ADM Scaffold
- K240226 — Pixie Skin Tag
- K240725 — PreXolid CAD/CAM abutments
- K240844 — Spectral CT 7500 RT
- K240916 — Surgical Face Mask (Tie on/ Ear loops)
- K241131 — edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK
- K241490 — Contour+ (MVision AI Segmentation)
- K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
- K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)
- K242132 — FREDDO
- K242372 — Mg OSTEOREVIVE, Mg OSTEOCRETE
- K242435 — Dental Barrier and Sleeves
- K242473 — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)
- K242813 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K242828 — Corplex P/ Theracor P/ Allacor P
- K242837 — BriefCase-Triage
- K242864 — ROSA® Knee System
- K242868 — Kinos Total Ankle System
- K242879 — dS Knee Coil 8ch 1.5T
- K243033 — dS Wrist coil 8ch 1.5T
- K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)
- K211943 — Microlyte Ag/Lidocaine
- K240160 — EGPS Navigated Instruments
- K240218 — Electric Breast Pump (F5055)
- K240321 — MP Pin flat without thread (36BMP000020/MP20)
- K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM)
- K240711 — Zipline Access Catheter
- K241242 — SIGNA MAGNUS
- K241267 — Hidroxa SE30
- K241337 — Electrically powered wheelchair (HP202)
- K242197 — IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
- K242809 — Ascent Cardiorespiratory Diagnostic Software
- K242899 — NOVA Minimally Invasive System
- DEN230087 — AMStent® Tracheobronchial Covered Stent System
- K240114 — UltraEzAir® (UEA1A)
- K240364 — RELIEEV Uterine Manipulator Injector (CUMI 5.0)
- K240468 — Alkaline Phosphatase
- K240596 — Cerebral Autoregulation Index (CAI) Algorithm
- K240849 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2
- K241221 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
- K241244 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
- K241272 — Stryker Steri-Shield 8 Surgical Hoods and Togas
- K241481 — xvision Spine System
- K241613 — Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
- K241632 — Electrically powered wheelchair
- K242556 — JLK-CTP
- K242784 — Vy Spine VyLam Laminoplasty System
- K242794 — ONCOZENE Microspheres
- K242839 — Safe Secure Sterilization Pouches and Rolls
- K231997 — SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
- K240192 — Single-use Extraction Baskets
- K240385 — VINT
- K241673 — Denture Base Resin (PN-Denture (Red, White))
- K241894 — Artix MT; Artix Thin-Walled Thrombectomy Sheath
- K242097 — DenMat Bulk Fill Composite
- K242536 — TauTona Pneumoperitoneum Assist Device (TPAD)
- K242781 — cvi42 Software Application
- K242795 — Getinge Assured MI Steam Migrating Integrator
- K242812 — NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
- DEN230078 — Versius Surgical System
- K232565 — UriSponge
- K232779 — QUEX ED; QUEX S
- K233265 — Monotime and Optime R
- K234110 — Belun Ring BLR-200 (BLR-200)
- K240143 — JDZygoma dental implants
- K240242 — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
- K240472 — PBM Hair Therapy Cap
- K240499 — ARTAIRA Arterial Compression Device (AACD01)
- K240501 — Spark Clear Aligner System
- K240797 — PPH Saliva Collection Kit
- K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
- K241153 — Progressive Orthodontics App
- K241163 — SPECTRALIS with Flex Module
- K241569 — syngo Application Software
- K241857 — LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
- K241971 — HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
- K242035 — Accure Laser System
- K242095 — Access Toxo IgM II
- K242133 — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)
- K242387 — Mobility Scooter (N3473)
- K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
- K242778 — X Sensor (Model: IOS-A15IF, HDI-15DGF)
- K242779 — Hood (DH-083ST)
- K242833 — Legend® Acetabular Shell
- K230325 — GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
- K233947 — KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System
- K240262 — BTI Interna 3.0 Dental Implant System UnicCa®
- K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
- K240786 — AutoChamber
- K240848 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance
- K240992 — eMVFit (MVF-10M)
- K241092 — Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
- K241430 — EchoMeasure
- K241491 — Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid
Data sourced from openFDA. This site is unofficial and independent of the FDA.