FDA 510(k) clearances — page 39
clearances on record, most recent first.
Clearances — page 39
3,801–3,900 of 176,479- K252526 — Rapid DeltaFuse
- K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip)
- K243680 — Neurovascular Insight V1.0
- K243709 — NeuroEars-Anna
- K243800 — PRO Pen Microneedling System (6883)
- K243834 — NobelZygoma TiUltra Implant system
- K251246 — Sparrow Ascent
- K251404 — Quantra QStat Cartridge
- K251440 — CRYOcheck Chromogenic Factor VIII
- K251593 — DenMat Multilayered Zirconia Disc
- K251811 — Motor and Apex Module (MaAM)
- K243660 — Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777) +8 more
- K243685 — MammoScreen BD
- K243692 — EnDrive (EnDriveUS)
- K250147 — CPS Locator 3D Delivery Catheter
- K251192 — Diagnostic Ultrasound System (13 models)
- K251277 — CoraForce Microcatheter, CoraFlex Microcatheter
- K251443 — PROMO
- K251604 — CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
- K251828 — CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set
- K251884 — One-Fil Putty Injectable
- K252302 — CARTO 3 EP Navigation System V8.1
- K252303 — Stem Extension Line (USTAR II System)
- K252362 — GBrain MRI
- K241152 — InSee
- K243965 — Origin
- K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)
- K250923 — Fine Osteotomy
- K250994 — ClearTip FNA and FNB Types
- K251029 — Vista OS, Vista AI Scan, RTHawk
- K251130 — Portable Oxygen Concentrator (JM-P50A)
- K251135 — Treace Medical Concepts (TMC) Implant Fixation System
- K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
- K251588 — LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
- K251647 — MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System
- K252244 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
- K252356 — The Acumed Wrist Fixation System - 2.4mm Screws
- DEN250002 — Delphi-MD System
- K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
- K250383 — Wearable Breast Pump (Model W6)
- K250417 — Remanufactured EndoWrist Cobra Grasper (420190)
- K250721 — LOCATOR® Angled Abutment
- K251229 — EndoFixTissue Fixation System
- K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
- K251471 — IPD Dental Implant Abutments
- K251481 — ACUSON Sequoia Diagnostic Ultrasound System +3 more
- K251563 — WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test
- K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
- K251590 — Methinks CTA Stroke
- K251837 — Salix Coronary Plaque (V1.0.0)
- K252061 — Distal Xtremities System
- K252104 — T1D1
- K243713 — Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)
- K250313 — Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
- K250387 — Remanufactured EndoWrist Long Tip Forceps (420048)
- K250399 — Remanufactured EndoWrist Cadiere Forceps (420049)
- K250539 — Remanufactured EndoWrist Tenaculum Forceps (420207)
- K252022 — OSSIOfiber® Interference Screw
- K252316 — Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)
- K243539 — Apollo TMS Therapy System
- K243604 — Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid
- K250167 — Evolution Spine Navigation Instruments
- K250271 — Neodent Implant System - Zirconia Implant System
- K251086 — PnueAira (PNCU-01)
- K251161 — ANTHEM® Fracture System
- K251913 — OsteoCentric® UnifiMI® TCS Plating System
- K243650 — Zio® monitor (DFG0001)
- K243851 — CHLOE BLAST
- K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
- K250170 — PHAROS
- K250397 — Helios Dermal Scaffold
- K250620 — KLS Martin Ixos System
- K250818 — Nerveblox
- K250867 — Dunamis Screw and Suture Locking System
- K251243 — OneRF Trigeminal Nerve Radiofrequency Probes
- K251747 — VEA Align; spineEOS
- K251834 — Persona Partial Knee
- K251871 — FEATHER 01 02 03 04 (Model:01)
- K251877 — JMS CAVEO A.V. Fistula Needle Set
- K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System
- K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative +1 more
- K252236 — CP Relief Wand Rx - TENS/NMES
- K252259 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
- K243437 — mOm Essential Incubator (ME1)
- K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
- K243600 — 3nethra neo HD FA
- K243905 — Stitch Cerclage Suture Tapes
- K250164 — Cassette Autoclave (ACA5)
- K250898 — Reprocessed HARMONIC 700 Shears (3 models)
- K250916 — WinForth (LM-E470KA)
- K251012 — TRUDERMAL Pro (ZLD-390)
- K251062 — Geistlich Bio-Gide +6 more
- K251176 — IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
- K251526 — FilmArray GI Control Panel M238
- K243279 — DOLORCLAST Focused Shock Waves
- K243579 — AeroJet Ventilation Catheter
- K243653 — KARL STORZ HOPKINS Telescopes for Urology
- K250163 — T2 Alpha Femur Retrograde Nailing System
- K250841 — Electrotherapy Electrodes
- K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (4 models)
Data sourced from openFDA. This site is unofficial and independent of the FDA.