FDA 510(k) clearances — page 21
clearances on record, most recent first.
Clearances — page 21
2,001–2,100 of 175,620- K250847 — VaporShield
- K250863 — FUJIFILM Ultrasonic Endoscope EB-710US
- K250974 — Bio Arterial Deluxe (IC-BAP-DX)
- K251085 — iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
- K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
- K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
- K251177 — Self-Seal Sterilization Pouch and Roll
- K251989 — VizMark Preloaded Tissue Marker Device (VM-0001)
- K252090 — Pterygoid Indication for GM Helix Implants
- K252120 — Fundus On Phone Non Mydriatic (FOP NM-10)
- K252273 — Therapy US
- K252391 — Revi System
- K252681 — EnCor EnCompass Breast Biopsy and Tissue Removal System
- K252745 — Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
- K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement
- K253489 — Swoop® Portable MR Imaging® System
- K253609 — TRAUMAGEL® 2.0 Hemostatic Gel
- K253749 — Affixus® Natural Nail® Proximal Humeral System
- K250988 — KLS Martin Pure Pectus System
- K251883 — MIM LesionID Pro
- K252482 — CogNet AI-MT+
- K252694 — Target Detachable Coil
- K252897 — APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista
- K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
- K252997 — HyperFlex® Bunion Correction System
- K253141 — DeepRhythmAI
- K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA)
- K250192 — Verisafe Safety Retractable Insulin Syringes
- K251598 — Intellidrop
- K252497 — SANSA HSAT
- K252826 — ARIX Femur Nail System
- K243449 — INFINITT DPS
- K250742 — Focused Cryotherapy System
- K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
- K251199 — Allia Moveo
- K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
- K252343 — Atlantis® Abutments in Titanium
- K252808 — GlasIonomer FX-LC
- K253706 — Lancing device (HH-XV-T)
- K250190 — Sequential Compression System (SCD600)
- K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System
- K251829 — DeGen Medical Patient Specific Implant (PSI) System
- K251936 — Ceribell Delirium Monitor System
- K252294 — Fetal EchoScan (v1.2)
- K252789 — Glass Ceramic
- K252862 — Electric Wheelchair (DH01126)
- K252994 — LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
- K243438 — MEMO Patch M (MPT-E08R-UNC01)
- K250512 — Augmented Gingival Matrix
- K250711 — VSP Orthopedics System
- K250743 — Remvia NightGuard
- K250764 — SpineLinc Anterior Cervical Implant System
- K250780 — ARTAssistant
- K250795 — PUREVUE FMS
- K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
- K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )
- K251514 — Overjet CBCT Assist
- K251657 — Personalized Therapy Comfort Settings (PTCS)
- K251722 — ProSeal Transfer Injector (421120, 421130, 421140)
- K251731 — KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)
- K252067 — Velora Acetabular System
- K252142 — Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
- K252151 — els unibond
- K252296 — OncoPatch
- K252465 — Any-Core
- K252494 — Electrically powered wheelchair (KZ301B)
- K252498 — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)
- K252504 — Gastric Alimetry
- K252605 — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
- K252825 — Manual Wheelchair (W45)
- K252828 — Manual Wheelchair (W47)
- K252841 — REAL INTELLIGENCE CORI XT (CORI XT)
- K253868 — QuietLab Pro
- K250679 — FFX Facet Fixation System
- K250791 — ASUS Ultrasound Imaging System (LU800 series)
- K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII)
- K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
- K251943 — Spineology Navigation Instruments
- K252126 — MitraPatch Mitral Valve Repair System
- K252429 — Vektor Computational ECG Mapping System (vMap®)
- K252588 — Mobility Scooter (T5)
- K252596 — Tigon Medical Knotless and Dual Javelin All-Suture Anchors
- K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
- K250692 — GentleBeam (GB1000)
- K250725 — Hugo RAS System
- K251203 — AVIEW Lung Nodule CAD
- K251601 — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem
- K251779 — Omnipod 5 algorithm
- K251881 — HippoMind (v1.0)
- K252213 — Bendit17 Microcatheter
- K253293 — VitaloJAK Clinic (Model 7100)
- K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
- K250896 — Aura Wave
- K252021 — Disposable Endoscopic Injection Needles
- K252069 — da Vinci SP Surgical System (SP1098)
- K252103 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
- K251370 — Cartesion Prime (PCD-1000A/3) V10.21
- K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
- K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)
Data sourced from openFDA. This site is unofficial and independent of the FDA.