FDA 510(k) clearances — page 27
clearances on record, most recent first.
Clearances — page 27
2,601–2,700 of 175,620- K251215 — Philips IntelliSpace Cardiovascular
- K251398 — IPL Hair Removal Device (IPL-001, IPL-002)
- K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
- K252059 — CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
- K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
- K252440 — EasyTeleMed (2.0.2)
- K252758 — Cannulated Screw and Kirschner (K wire) System
- K252769 — Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)
- K250026 — Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
- K250083 — PRO-DOSE System
- K250767 — Newclip Patient-matched instrumentation non sterile PSI
- K251501 — Visby Medical Men's Sexual Health Test
- K251767 — Vena MicroAngioscope System
- K251825 — Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
- K251899 — E Blator
- K252096 — Light Therapy Decollete Mask (1019135)
- K252447 — Picosecond laser device (BMPS4)
- K252804 — Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL,
- K243270 — TigerConnect Alarm Management
- K250050 — miDiagnostics HSV-1&2 CSF Test
- K250331 — Astrasono A3Pro Bladder Scanner (A3Pro)
- K251197 — Dexter L6 System
- K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter
- K251690 — Arthrex SpeedFLEX Implant
- K251799 — Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06)
- K252072 — Francisella tularensis Real-time PCR assay
- K252085 — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)
- K252106 — External Fixation Mini Rail System
- K252722 — Biopsy Forceps
- K243833 — Portable oxygen concentrator (JAY-1000P)
- K243983 — Paltop Dental Implant System
- K250023 — SMART PCFD
- K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
- K251104 — SureTome SW Sphincterotome with DomeTip
- K251334 — NEW DOUBLO 2.0
- K252051 — allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)
- K252054 — SpineAR SNAP (SyncAR Spine)
- K252441 — Primero Safe Access System
- K252594 — UltraGuideCTR® image guided soft tissue release system
- K252770 — iLet ACE Pump
- K253236 — G-BLOCK
- K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
- K250318 — Planmed XFI
- K250659 — LoFric Origo
- K251204 — FUJIFILM Stiffening Wire Device (SW-2000)
- K251208 — Tuned Self-Fitting Mobile App
- K251262 — S.I.N. Dental Implant System
- K251275 — VitalStream ART Connect; VitalStream-Hemo
- K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
- K251919 — Thulium Laser System (Deluxlase)
- K251986 — AUXILIARY WATER TUBE MAJ-855
- K252105 — Ligence Heart
- K252221 — Inset Reverse Total Shoulder System
- K252435 — Magnetic Surgical System
- K252700 — Optima Coil System (Optima Packing Coil System)
- K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps
- DEN250016 — Essilor® Stellest®
- K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
- K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)
- K250076 — Endeavor Stand-Alone Cervical IBF System
- K250837 — Pulse Oximeter
- K251148 — JDEvolution Plus L and JDEvolution Plus LE
- K251465 — Root canal repair materials (nRoot BP)
- K251512 — Hi bebe super (BT-150B)
- K251527 — Brain WMH
- K251789 — EMBOTRAP III Revascularization Device
- K251791 — Auxano® Wedge Fixation System
- K251812 — Steripath® Flow Blood Collection System
- K251868 — Panther Fusion GI Bacterial Assay
- K251971 — RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
- K251993 — Panther Fusion GI Expanded Bacterial Assay
- K251997 — Single-Use Biopsy Valve (MAJ-1555)
- K252013 — EnSite X EP System
- K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
- K252063 — Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)
- K252102 — Alinity m HCV
- K252371 — uMR 680
- K252725 — Stem Extension Line (U2 Total Knee SystemPSA Type)
- K243910 — Retraxil
- K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
- K250045 — uWS-Angio Pro
- K250071 — Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
- K250792 — t:slim X2 insulin pump with interoperable technology
- K251206 — Digital X-Ray DentiMax Pro Imaging System
- K251734 — ProVee Video Processing Unit (PV-003)
- K252183 — Resitu Slider 09 (RESL09)
- K252227 — Pounce(TM) Sheath
- K252680 — Celerity 20 HP Biological Indicator
- K252682 — LenSx Laser System (8065000944)
- K252689 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
- K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
- DEN240080 — Biolinq Shine Autonomous Time-in-Range Microsensor
- K250209 — Polyvinyl Alcohol Embolic Microspheres
- K251140 — Zenflow Spring Scope
- K251483 — SwiftSight-Brain
- K251894 — Himaging Bronchscope System
- K251973 — Luminance Red Cold Sore Device (TN1927G)
- K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)
- K251987 — Rapid Aortic Measurements
- K252043 — Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
Data sourced from openFDA. This site is unofficial and independent of the FDA.