FDA 510(k) clearances — page 57
clearances on record, most recent first.
Clearances — page 57
5,601–5,700 of 176,479- K242111 — VIVACE
- K242192 — Disposable Sphincterotome
- K242324 — DUTAU-NOVATECH®
- K242428 — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
- K242580 — Unimed Reusable Finger Clip SpO2 Sensors (4 models)
- K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
- K243243 — Delphi MCS Electrode Cap
- K243465 — Diode Laser Hair Removal Device (5 models)
- K243488 — VMAT PRO
- K243784 — Stryker Orthopaedics Hip Devices Labeling Update
- K243794 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K243817 — Scorpio Universal Dome Patella +5 more
- K244034 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
- K250044 — Celerity 5 HP Biological Indicator (LCB052) +3 more
- K250055 — BPS - Bone Fragment Fixation Plates, Screws and Washers
- K250061 — Celerity Incubator
- K250066 — Resolution Clip (6 models)
- K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial
- K241488 — TrainFES Advance
- K241593 — BoneMetrics (US)
- K242352 — Accurate Mini Non-invasive blood pressure monitor (AMB-001)
- K242896 — Caliber Intramedullary Fixation System
- K242983 — CROMA Electrosurgical Generator (PRD-EMR-050)
- K243555 — LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
- K243580 — GraftGun Universal Graft Delivery System (GDS)
- K243790 — GRYPHON X Anchor; HEALIX TRANSTEND Anchor
- K242916 — Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
- K243138 — Geon (S2) Nasal Aspirator
- K243333 — rTOP
- K250068 — Venclose digiRF Generator (VCRFG1)
- K240402 — Cito CBC System
- K241368 — Sonicaid Team3
- K241375 — IdentiTi Porous Ti Interbody System +11 more
- K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
- K241590 — Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
- K243146 — iCare APP
- K243182 — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode
- K243268 — TipTraQ (TTQ001)
- K243393 — JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
- K243908 — Tiger 2 System
- K250035 — Contour ProtégéAI+
- K241193 — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
- K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P) +4 more
- K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
- K241694 — ZeTTA PACS
- K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
- K242442 — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
- K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
- K242982 — Mobility Scooter (MS160A)
- K243150 — Nuance Audio Hearing Aid Software
- K243441 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
- K243572 — Game Ready system (550500-04) +11 more
- K243665 — Crius PEEK Suture Anchor System (4 models)
- K243742 — Arthrex DynaNite Nitinol Staples
- K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
- K233956 — Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
- K241270 — BTL-754
- K241292 — MyShoulder Planner (5.3SSWPL)
- K242568 — Wrist Blood Pressure Monitor (OHMS11, OHMS12)
- 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 +3 more
- K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT +4 more
- 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 ) +1 more
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.