FDA 510(k) clearances — page 44
clearances on record, most recent first.
Clearances — page 44
4,301–4,400 of 175,620- K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
- K242166 — TribusConnect
- K243178 — Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di
- K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001)
- K250263 — Disposable Grasping Forceps FG-52D/FG-54D
- K250663 — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
- K250946 — Denture Base Resin DT20
- K242618 — Layer 7-T
- K250601 — Neuro Omega System; NeuroSmart System
- DEN240020 — Visby Medical Women's Sexual Health Test
- K233953 — Makani Science Respiration Monitoring System
- K234067 — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
- K241927 — Synthes Graphic Case & Tray System
- K242022 — Access Toxo IgG
- K242952 — INNOVANCE Antithrombin
- K243228 — Flexi-Seal AIR (with ENFit Connector)
- K243520 — Bullsai Confirm
- K244030 — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
- K244044 — PBC Separator with Selux AST System
- K250571 — CATALYSTEM Femoral Stems
- K250596 — Arthrex FiberTak Suture Anchor
- K241785 — StarFormer (M008-3T)
- K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48)
- K241962 — Crossloop
- K242201 — HyperSuture White/Green Extension Line
- K242745 — AI-Rad Companion Organs RT
- K242919 — V5med Lung AI
- K243038 — Salix Central
- K243426 — Nurochek-Pro System
- K243708 — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)
- K243768 — iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System
- K244046 — Edwards eSheath Optima introducer set
- K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)
- K250092 — HC Biologics Osteopoint Spinal Fixation System
- K250555 — MallyaD injection pen adapter (MallyaD)
- K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
- K240189 — NM-01/CPT neurometer (NM-01/CPT)
- K241855 — SB Knife Jr2 (MD-47702 and MD-47702L)
- K242669 — SnapshotGLO (KB100)
- K243831 — Rayvolve LN
- K243840 — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
- K243891 — EarliPoint System
- K243995 — Arthrex Humeral Plating System and Cerclage Button
- K244003 — Electrically powered wheelchair
- K250134 — Power Wheelchair (YH-E6011,YH-E6013A)
- K250194 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
- K250542 — AC3 Range Intra-Aortic Balloon Pump
- K250225 — Bolt Intravascular Lithotripsy (IVL) System
- K250668 — Aventus Thrombectomy System (IM-2100)
- K241921 — Alinity m BKV
- K242356 — TIDAL Fusion Cage System
- K242893 — VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
- K243052 — Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))
- K243525 — SonoTAP and SonoTAP II
- K243642 — UltraCor Twirl Breast Tissue Marker
- K243865 — AERO MIS Facet Fusion System
- K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
- K243991 — Klassic Knee System - Revision Tibial Baseplate
- K250013 — VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)
- K250125 — LMNT O2
- K250182 — Innovasis Navigation Instruments
- K250603 — AxTiHA® Stand-Alone ALIF System
- K240761 — Arisure® Closed Male Luer with Spike Adapter (YM060)
- K241065 — ChecQ (AC100)
- K241833 — V-GRAD
- K241890 — Philips Holter Analysis System
- K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
- K242107 — CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)
- K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
- K242564 — Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit)
- K242888 — Electrohydraulic Lithotriptor (TCS-B3-II)
- K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- K243032 — EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
- K243185 — REMI Remote EEG Monitoring System
- K243451 — FiAPC plus probes
- K243630 — Medical Laser System Incanto / Evoline Platinum /Evoline
- K243649 — BD Vacutainer® Multiple Sample Luer Adapter
- K243808 — Rayvolve PTX-PE
- K243958 — Consolidated Operating Room Equipment (CORE) 2 Console
- K243980 — ARVIS Surgical Navigation System
- K250106 — Signos Glucose Monitoring System
- K250186 — GoLIF! Lumbar Interbody Fusion System
- K250403 — Catamaran SI Joint Fusion System
- K250513 — IntelliSep Test (CV-ICG-048)
- K250517 — Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006
- K250556 — Porous Biologic Scaffold
- K250561 — Natural Cycles
- K241704 — Endoscopic Water Pump
- K241884 — HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
- K241961 — Vent Creativity Knee v1.0 (Hermes)
- K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
- K242771 — Tesera-k PL System and Tesera-k XL System
- K242958 — Joylux Intimacy Gel (PG3100)
- K243016 — Starlight Imaging Catheter
- K243292 — brAIn Shoulder Positioning
- K243922 — Revogene
- K243928 — ViaOne Epicardial Access System
- K243975 — Knee+
- K243988 — RootMend MRR
- K250463 — Ameda GLO Wearable Breast Pump (Model W8S)
Data sourced from openFDA. This site is unofficial and independent of the FDA.