FDA 510(k) clearances — page 9
clearances on record, most recent first.
Clearances — page 9
801–900 of 175,620- K253459 — OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
- K253805 — Knee+
- K253832 — Dilation Balloon Catheter
- K254173 — ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
- K260009 — LungPoint Virtual Bronchoscopic Navigation (VBN) Software
- K260054 — I.T.S. PRS Phoenix II
- K260228 — POYA 3.5mm Medial Proximal Tibia System
- K260411 — PC Fix System
- K260429 — Control-IQ+ technology
- K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
- K260599 — INDIGO® Aspiration System INDIGO Link
- K260982 — Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)
- K260988 — °M Warmer System with °M Station
- K260993 — Amplatzer TorqVue Delivery System
- K260999 — LoFric Elle Pro
- K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute
- K261043 — AUTOBAHN Nailing System
- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
- K252389 — Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
- K252407 — OxyGo Portable Oxygen Concentrator (1400-7000)
- K252436 — Tula Tympanostomy Tube Delivery Device
- K252815 — ProBeam 360 Proton Therapy System v3.0
- K253589 — Liberant RX Aspiration Catheter
- K253752 — ARTIS genio floor; ARTIS icono.explore floor
- K254237 — CCI PACS VIEWER (PACS-US-001)
- K254248 — Introducer Sheath Set
- K260152 — Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)
- K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
- K260320 — Lunit INSIGHT MMG (v1.1.10)
- K260785 — DS Core CBCT Anatomy
- K260947 — 0.55T 12Ch Breast Coil
- K260976 — NeuroBlate System
- K261012 — OptiMap Catheter - 60mm (OPTI-CATH2-60)
- K252306 — Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100)
- K253077 — uOmnispace.MR
- K253163 — EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
- K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
- K253256 — myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
- K253765 — VANISH PRO
- K260150 — LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
- K260237 — Mobility Scooter (X-12, X-14, X-17)
- K260239 — Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
- K260570 — corra cervical plating system
- K250793 — RhythmStar System (SL)
- K253982 — Korotkoff sound blood pressure monitor
- K254046 — BosCATH Support Catheter
- K260216 — CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System
- K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
- K260518 — IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)
- K260573 — EvoEndo Single-Use Endoscopy System
- K260921 — Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
- K242163 — SmartSurgN Visualization System
- K252332 — Folliscan
- K252718 — Lunar Astra
- K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
- K253213 — SAGI Cervical Cage System
- K253558 — Luminoah FLOW Enteral Nutrition System
- K253638 — xStep (xStep)
- K253806 — Power Wheelchair (N5919 series)
- K260153 — Q-Switched Nd: YAG Laser System (Glamor Q)
- K260212 — EnSite X EP System
- DEN250033 — XplantR Explant Tool
- K252237 — EdgeFlow UW20
- K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
- K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
- K252338 — MySleepDash
- K252945 — Novasight Hybrid System
- K253970 — Wovyn Depth Electrode
- K254279 — Edwards eSheath+ introducer set
- K260696 — MTS Gepotidacin 0.016-256 µg/mL
- K260900 — DYNEX® External Fixation Systems
- K260929 — Neonav ECG Tip Location System
- K260934 — TITAN Nail; APTUS K-Wire System
- K261261 — Dura-Arch
- K251478 — ClearTip TBNA Type
- K251658 — Endoflux Biliary & Pancreatic Stent Sets
- K252317 — Zenith Micro Guidewire
- K252318 — Insufflator (OPTO-IFL1000)
- K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- K253170 — uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
- K253260 — ORIO-3D Cage System
- K253523 — Freedom DS Decompression System
- K253537 — 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)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)
- K253804 — DESS Dental Smart Solutions
- K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,
- K253907 — Disposable Radiofrequency Cannula
- K254101 — Julva Velvé Water-Based Personal Lubricant
- K254216 — Enso for Migraine
- K254223 — Next Generation 088 Catheter
- K254273 — Verisafe Safety Sterile Needles (SSN)
- K254274 — ARx® SAI Implant System
- K260011 — Foundation Surgical Navigated Lateral Disc Prep Instruments
- K260020 — Redermo Wound Matrix
- K260903 — Hot Pink Pad Warming System
- K252258 — VERIQA RT EPID 3D
- K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
- K252728 — IDS-iSYS Total Testosterone
- K252774 — Uni-C Cervical Cage System
- K252843 — STERRAD 100NX Sterilization System with ALLClear Technology (10104)
- K253337 — REGEN Bioactive Cement
Data sourced from openFDA. This site is unofficial and independent of the FDA.