FDA 510(k) clearances — page 30
clearances on record, most recent first.
Clearances — page 30
2,901–3,000 of 175,620- K252019 — CurvaFix Low Profile System
- K252364 — Edwards eSheath Optima introducer set
- K252380 — Invisalign System
- K252392 — Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set
- K243767 — SV600, SV800 Ventilator
- K243901 — SmartPilot YpsoMate NS-A2.25
- K250148 — Medical Gas Analyzer (AG200)
- K250788 — Definium Tempo Select
- K251429 — OTC 4-Channel Rechargeable TENS Unit
- K251484 — CT:VQ
- K251594 — truFlex
- K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
- K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
- K252030 — RadiForce GX570; RadiForce GX570-AR
- K252057 — Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System
- K252350 — da Vinci SP Firefly Imaging System
- K252383 — Somfit D
- K252411 — JARVIS Glenoid Reverse Shoulder Prosthesis
- K252437 — JAZZ Spinal System
- K252505 — Powder-Free Vinyl Exam Gloves, clear
- K241766 — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
- K241882 — Fetal & Maternal Monitor (F15A, F15A Air)
- K243166 — Dermalage
- K243687 — Vital Signs
- K243774 — ELID (Endoscopic Less Invasive Decompression) System
- K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
- K250625 — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
- K250947 — VistaSoft 4.0 and VisionX 4.0
- K251068 — KnoxFog Anti-fogging Device
- K251382 — Phoenix Sinus Tarsi Stent System
- K251415 — Additively Manufactured Aligner Resin
- K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
- K251716 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
- K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
- K252118 — CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
- K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K244061 — X-Wire Guidewire
- K250049 — Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)
- K250261 — Heager Medical Laser Family (Sabrina/Adolf)
- K251305 — Ultra-Fast Vitri; Ultra-Fast Warm
- K251983 — Brainomix 360 Triage Stroke
- 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); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoject 6mL Syringe, Luer-Lock Tip (1180600777); Monoject 12mL Syringe, Luer-Lock Tip (1181200777); Monoject 20mL Syringe, Luer-Lock Tip (1182000777); Monoject 35mL Syringe, Luer-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec
- K243685 — MammoScreen BD
- K243692 — EnDrive (EnDriveUS)
- K250147 — CPS Locator 3D Delivery Catheter
- K251192 — Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)
- 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; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.