FDA 510(k) clearances — page 7
clearances on record, most recent first.
Clearances — page 7
601–700 of 175,620- K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
- K253235 — Introcan Safety® Deep Access XL IV Catheter
- K253642 — Jada System (Jada-2002)
- K253716 — uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super
- K253756 — cobas liat CT/NG nucleic acid test
- K253759 — cobas liat CT/NG/MG nucleic acid test
- K253935 — medXion NEXUS
- K254028 — Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)
- K254050 — Manual Tissue Removal Device
- K254120 — SubtleHD-CT (1.x)
- K260059 — NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)
- K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
- K260506 — Ventana® P/T Lumbar Interbody System
- K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
- K260771 — TruSelect 2.6 Microcatheter
- K260989 — Varion Thoracolumbar Fixation System
- K261264 — Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+
- K261273 — Neurophet AQUA
- K261289 — UNiD Spine Analyzer (SW3002)
- K252601 — Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)
- K252652 — Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr
- K252776 — ARIES Anterior Cervical Plate Systems
- K253078 — ART.1-US
- K253372 — ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
- K253676 — CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)
- K253883 — Bonalive Maxillofacial
- K254013 — SubtleHD-PET (1.x)
- K254048 — Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
- K254133 — ENTity USB Videoscope System
- K260085 — RAYMO Mobile X-ray System (Model: RAYMO)
- K260111 — Palmtop Ultrasound Diagnostic System (MT10P/MT10)
- K260485 — Any-Etch
- K260565 — SmartClip Delivery Catheter (ADR-1715)
- K260892 — Suction Pump (SU-90)
- K261134 — Dormiva Anti-Snoring Mouth Guard
- K261224 — MatriDerm
- K261241 — TriMed Compression Screws
- K261317 — BriefCase-Triage
- K252591 — Automatic Micro Needle System (CODE-X)
- K252638 — VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)
- K252653 — ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
- K253061 — Portable Neuromodulation Stimulator (PoNS)
- K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform
- K253241 — Electric Wheelchair (Y207BL)
- K254073 — StatSeal Disc
- K254125 — Electric Breast Pump (HL-3058 II Pro)
- K260032 — Morph
- K261363 — Y-Knotless Flex Anchors
- K252731 — Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
- K254192 — Senhance Ultrasonic System
- K260051 — CorVision® (91-205-Z0014)
- K260235 — CellDx-Tissue
- K260378 — Rayvolve
- K260415 — myLEDmask 2 (MJ-144)
- K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
- K260837 — VersaLift Expandable System
- K260850 — OSTEOMNI SPINAL CAGES SYSTEM
- K261196 — Promisemed VeriEcto Automatic Biopsy Needles
- K250964 — Protable Phlegm Suction Unit (JMA D01)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K252880 — Pytheas Your Guided Trajectory
- K252953 — Velmeni for Dentists (V4D) Endo-Perio
- K253696 — CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)
- K254178 — SAYA 86 Radial Access Guide Catheter
- K254228 — KARL STORZ Trocars with Valve Seals
- K260196 — ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm)
- K260805 — Dual Core
- K260842 — HardyDisk AST Gepotidacin 10µg (GEP10)
- K260846 — Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos
- K261214 — PICO SHINING (PICO-K; PICOFY)
- K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
- K261145 — Avanti Distal Elbow ORIF System
- DEN250013 — Modius Spero
- K250814 — Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
- K252617 — MiroCam® Capsule Endoscope System
- K252621 — DeepSkin (DEP100)
- K253013 — Disposable Stone Retrieval Balloon Catheter
- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
- K253396 — AYON Body Contouring System (AYON SYSTEM)
- K253679 — Hydro Irrigation System
- K253991 — Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
- K254215 — Arthrex Beaming System
- K260321 — HipGuide (V 1.0.0.0)
- K260419 — LingOral Dental Design System
- K260788 — Smylio Aligners
- K260792 — AerFrame Patient Immobilization System (AFPIS)
- K253647 — Evita (V800); Evita (V600)
- K253739 — SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
- K253826 — Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
- K253837 — SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
- K253992 — Veritas Reverse Total Shoulder System
- K254183 — MR Conditional Cup Electrodes
- K254276 — Lynx Aspiration Catheter System
- K260460 — Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
- K260974 — CO2 Laser Machine (Monica-I,Monica-II)
- K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
- K253027 — Anchor with Fiber Wire and Disposable Inserter
- K253152 — BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
- K253855 — KardiaPSI Balloon Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.