FDA 510(k) clearances — page 49
clearances on record, most recent first.
Clearances — page 49
4,801–4,900 of 175,620- K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP
- K242757 — Rotarex Atherectomy System
- K243025 — Ureteral Access Sheath
- K243060 — TeleRPM Gen2 Blood Glucose Monitoring System
- K243202 — MTS Ceftobiprole 0.002-32 µg/mL
- K243410 — simpli-COLLECT STI Test
- K243442 — iBOT® PMD
- K243712 — WasherCap Mini Fixation System (Model 45)
- K243726 — Osprey Suture Anchor
- K241915 — CareSuperb COVID-19 Antigen Home Test
- K242217 — Surcam Dental Implant System
- K243042 — Co-Ablation System with Sterile Co-Ablation Probe
- K243117 — Digital Video Processor
- K243213 — Self-Forming Magnet (FLEX SFM)
- K243387 — GYDER® Hip System
- K243673 — Xenco Medical CancelleX Cervical Interbody System
- K243740 — Versalock Upper Limb Plating System
- K243374 — HemosIL CL HIT-IgG(PF4-H)
- K243423 — LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)
- K243439 — Medical Monitor (27HS714S)
- K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M
- K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
- K244025 — Argo Knotless GENESYS Anchor
- K244027 — SANSA HSAT
- K231297 — Firstar Dental Unit
- K241266 — Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
- K242941 — CO2 Laser Therapy Systems (SHE-LSP003-1)
- K243229 — Bunkerhill AVC
- K250014 — Symani Surgical System (820-03830)
- K241057 — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
- K241107 — Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)
- K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity
- K241232 — Galen Second Read
- K241239 — OrganProtex HTK Solution
- K241793 — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
- K242322 — Bone Marrow Biopsy Needle
- K243657 — ClearPoint System (Software Version 3.0)
- K243739 — AxCess® Expandable Interbody System
- K244023 — MAGENTIQ-COLO (ME-APDS)
- K241199 — Rotatable Connector (5944RL)
- K241234 — OTS 25-L (100-5)
- K241367 — RF Cannula
- K241728 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
- K241819 — CephNinja
- K242714 — Mobility Scooter (S-01); Mobility Scooter (S-02)
- K243158 — TeraRecon Aorta.CT (1.1.0)
- K243219 — MONARCH Platform (MON-000008)
- K243624 — Acu-Sinch Knotless Mini
- K243668 — ProLift Pivot Expandable Spacer System
- K240311 — JETT Medical II
- K241357 — XT3 System
- K241956 — Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
- K242446 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
- K242835 — Suture-TOOL System
- K243008 — Arthrex NanoScope System
- K243139 — Reverso Pro System
- K243350 — Rapid Neuro3D
- K243976 — ZeroClear Bag Access (423100)
- K243977 — EMPHASYS Acetabular System
- K243982 — Nicolet EDX
- K243985 — Rio Drug Reconstitution Transfer Device
- K241443 — Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)
- K241444 — Biliary Pancreaticobiliary Scope System
- K242288 — Advanced Cryo Wart Remover
- K243303 — Ziehm Vision RFD 3D
- K243929 — Oligio X
- K243955 — Precision AI Surgical Planning System (PAI-SPS)
- K241910 — Neonav ECG Tip Location System
- DEN230051 — Myocene
- K240217 — cobas® liat CT/NG nucleic acid test
- K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
- K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
- K241269 — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
- K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)
- K241949 — Digital Color Doppler Ultrasound System (P60 Series)
- K242051 — VersaD Delivery Catheter
- K242064 — Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut)
- K242171 — TechCare Trauma
- K242336 — hygh-tec Drainage II
- K242374 — ULSPIRA TS Nitric Oxide Therapy System
- K242608 — Embozene Color-Advanced Microspheres
- K242705 — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
- K242765 — Electronic Apex Locator (Alpha Apex I)
- K242825 — Prenuvo Body Composition
- K242860 — Type 5 Integrating Indicator for Steam (CSPN-15)
- K243067 — The ETHICON Total Energy System
- K243218 — TBS iNsight (V4)
- K243249 — TriALTIS Spine System
- K243291 — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
- K243315 — ProGrip Self-Gripping Polypropylene Mesh
- K243502 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
- K243545 — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn
- K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
- K243605 — Aurora
- K243606 — Babyroo TN300
- K243706 — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules
- K243892 — Affera Integrated Mapping System
- K243935 — Aptima CMV Quant Assay
- K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)
- K233770 — Pepper EMS Training System
Data sourced from openFDA. This site is unofficial and independent of the FDA.