FDA 510(k) clearances — page 44
clearances on record, most recent first.
Clearances — page 44
4,301–4,400 of 176,479- K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
- K250984 — Maestro System (REF100)
- K251116 — Luja Coudé
- K251210 — Ampa One System (AMPA-001)
- K251329 — Diode laser device (RF3120-BI)
- K251431 — FIX-C PEEK ACIF SA System
- K251642 — Dental CBCT X-ray System
- K251654 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter
- K251660 — T3 Pro Implants ZimVie Packaging System
- K242846 — Doppler FHR Detector (BF-500D+, BF-560)
- K243079 — NeuroTrac® MyoPlus Pro (MYO120U)
- K243175 — Disposable Intermittent Catheter (TPU Catheter)
- K243179 — Sterilization Pouch and Roll
- K243275 — Equinoxe® Scapula Fracture System
- K243391 — AISight Dx
- K243636 — Neuralytix iD3 System (NTX-9001)
- K250519 — Lap.Ox Laparoscopic Tissue Oximeter
- K250548 — Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
- K250929 — TriMed Ulnar Osteotomy System (4 models)
- K250940 — Atmo Gas Capsule System
- K250956 — HardyDisk AST Gepotidacin 10µg (GEP10)
- K250967 — Sherlock
- K251395 — The Rialto SI Fusion System
- K251613 — SwissGraft X
- K251632 — Optimas MAX System
- K251694 — safety lancet
- K251717 — Freedom® Total Knee System Titanium Tibial Base Plate
- K251728 — Velacur One (LI-1100)
- K242845 — EGIS Biliary Double Bare Stent (BDB080405)
- K243112 — Curapuls 670
- K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313)
- K250302 — Flexible Partial Resin
- K250329 — GeniPhys Collymer Self-Assembling Scaffold
- K250747 — Globe® Pulsed Field System
- K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
- K250921 — CORIOGRAPH Pre-Op Planning and Modeling Services
- K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer
- K250966 — CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)
- K251003 — X-PAC® LLIF Expandable Lateral Cage System
- K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer
- K251606 — Power Wheelchair (D26)
- K251611 — Optiflow+ Nasal Cannula - Small (OPT942) +5 more
- K251627 — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue) +4 more
- K251725 — ANAX OCT Spinal System
- K243009 — MIST IC
- K250268 — HyperSnap Surgical System (HSS)
- K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
- K251358 — Bridge Plus Occlusion Balloon (590-002)
- K251362 — PediFlex Flexible Nail System
- K251644 — ProAM ALIF System
- K251648 — GPS Advanced; GPS Advanced Cannula
- K242924 — OPXION Optical Skin Viewer (OPXSV1-01F)
- K243142 — Cranial 4Pi Immobilization
- K243339 — WiTOF
- K250143 — Digital Prism Correction Feature (DPCF)
- K250470 — Ear Thermometer (3 models)
- K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190) +4 more
- K250885 — Ceftobiprole BPR 5 µg Disc
- K251271 — TempFIT Temporary Crown and Bridge Resin
- K251570 — Hippocampe Marathon and Trail
- K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.
- K242911 — Medconn Glycated Hemoglobin Test system
- K242964 — Celsi Warmer
- K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
- K242981 — Atellica IM Thyroglobulin (Tg)
- K242985 — CollOvine Wound Dressing
- K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
- K243053 — Navient Image Guided Navigation System (ENT) (955-NC-NC)
- K243062 — BD Intelliport System +5 more
- K243120 — HybridAPC probe
- K243168 — Alinity i Rubella IgG
- K243398 — CT Scanner TSX-501R/1 V11.1
- K243589 — PAL Sterilization Case
- K243978 — LED Facial Mask
- K250037 — Incompass Total Ankle System
- K250151 — Us2.ca
- K250566 — EsCem RMGI
- K250583 — AdheResp Smart Breath-actuated Mesh Nebulizer
- K250732 — Disposable Endoscopy Valve Set
- K250877 — TMINI Miniature Robotic System
- K250880 — LED LIGHT MASK (A093)
- K250968 — PathPresenter Clinical Viewer
- K251114 — FloPatch FP120
- K251224 — Restrata Soft Tissue Reinforcement (STR)
- K251240 — Branchor X Balloon Guide Catheter
- K251248 — ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)
- K251258 — MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula
- K251560 — FUBUKI XF-R Neurovascular Long Sheath
- K251567 — NovoSorb BTM
- K242944 — Leone Orthodontic Implant TAD (Temporary Anchorage Device)
- K250515 — EpiMonitor
- K251235 — Electrosurgical Pads
- K242224 — Happy Health Home Sleep Test
- K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more
- K242917 — Enteral Drainage System, Enteral Medicine straw
- K242922 — Extracorporeal Shock Wave Lithotripter (U200)
- K242933 — SPINEART Navigation Instrument System
- K243014 — EyeQ nanoECP
- K243039 — Ureteral Stents (AF-D series)
- K243102 — Mobility Scooter (JT10)
Data sourced from openFDA. This site is unofficial and independent of the FDA.