FDA 510(k) clearances — page 53
clearances on record, most recent first.
Clearances — page 53
5,201–5,300 of 176,479- 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) +2 more
- 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 (3 models)
- 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) +6 more
- 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)
- K250468 — iSLEEVE Introducer Set
- DEN240018 — CORIS System
- K241791 — Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
- K241842 — Luer-Split MAJ-2092
- K242241 — Sunny
- K242486 — Tyber Medical Anatomical Plating System
- K243092 — AcuPebble Ox (200)
- K243443 — EXPD 4343N1 +9 more
- K243472 — 1NEED Pro
- K243689 — AVIEW
- K243987 — TriMed Elbow and Forearm System
- K243999 — TriMed Ankle Fixation System
- K250042 — PeekMed web
- K250131 — IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
- K250171 — IPL Hair Removal Device (BE965A, BE965B, BE965C)
- K250210 — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) +2 more
- K250429 — DSPS-Prominent® baseplate, MR (113820) +13 more
- K250502 — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)
- K240287 — LYHER® Oral fluid Multi-Drug Test Kit (Cube)
- K240933 — CarbonCool® System
- K241729 — Hard Splint & Thermo-Adaptive Splint
- K241783 — FortiVy OsteoVy Lumbar IBF
- K241937 — Klarity SGRT System (ARSG-E1A, ARSG-E3A)
- K242161 — Radlink GPS Pro Imaging
- K242533 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K242683 — QP-Prostate® CAD
- K243553 — QuikClot Control+ Hemostatic Device
- K243556 — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
- K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
- K250413 — Aglaia LED Beauty Device (BP-D2309)
- K250494 — The OsteoCentric Bone Plate and Screw System
- K241975 — SERV MEDICAL CDSS
- K242140 — Air Compression Leg Massager (K-705)
- K243504 — MAIA (AHMACME001)
- K243646 — Ziehm Solo FD
- K243802 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation
- K243862 — LVivo Software Application
- K243867 — LAGIS Suction Irrigation System
- K243869 — Horizon® 3.0 TMS Therapy System (3 models)
- K244056 — DOC Band 3D
- K250379 — SIGNA Prime Elite
Data sourced from openFDA. This site is unofficial and independent of the FDA.