FDA 510(k) clearances — page 39
clearances on record, most recent first.
Clearances — page 39
3,801–3,900 of 175,620- K250544 — Knotilus+ Biocomposite Knotless Anchor
- K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
- K250778 — Sil-Flow
- K250938 — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)
- K251044 — 93 NeuFlex Catheter
- K251211 — ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach
- K251292 — RECLAIM Monobloc Revision Femoral Stem
- DEN240035 — ConcizuTrace ELISA
- K242586 — ArgoCap (200.52)
- K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
- K242684 — Harioculture TL-16 Time-lapse Incubator
- K250532 — Solawave 2-in-1 Skincare Mini (Model: 61043)
- K250630 — Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
- K250639 — DESS Dental Smart Solutions
- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
- K250897 — Koala Intrauterine Pressure Catheter (IPC-5000E)
- K250910 — Optilume® High Pressure Urological Balloon Dilation Catheter
- K250920 — Arthrex Spine Compression FT Screw
- K250935 — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)
- K250980 — Physica System (Physica CR Porous Femoral components)
- K251052 — Trivicta® Hip Stem
- K251493 — Skin Clinic Freeze Point for Warts and Skin Tags
- K242527 — The Karma® Fixation System
- K242637 — MEM Clear Aligner System
- K242857 — ClearHemograsper
- K243116 — FlareHawk Interbody Fusion System
- K243122 — uMR Omega
- K243302 — 3DMatrix DynaFlex (DynaFlex)
- K243429 — HJY VisualNext 3D Endoscopic Vision System
- K243762 — Synapse 3D Base Tools (V7.0)
- K243793 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K243866 — InVision Precision Cardiac Amyloid
- K250493 — MotiliCap GI Monitoring System
- K250528 — Stryker AlphaVent Knotless SP Biocomposite Anchor
- K250798 — Control-IQ+ technology
- K251109 — SMARTDent
- K251230 — The Alma Hybrid Laser System
- K251239 — GrandioSO Unlimited
- K251276 — Swoop® Portable MR Imaging® System
- K242485 — EveryWare
- K250199 — VitalFlow Console
- K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
- K250370 — SCENARIA View Phase 5.0
- K250489 — FP3D
- K250534 — Biomic Color Opaque
- K250602 — X-PAC® N-GAGE Lumbar Plate System
- K250866 — Sovereign Posterior Cervical System
- K251231 — ViewFlex X ICE Catheter, Sensor Enabled
- K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System
- K242755 — Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
- K243301 — MapRT
- K243411 — Diagnostic X-ray System
- K243601 — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
- K243643 — restor3d Reverse Total Shoulder Arthroplasty System
- K250020 — Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost
- K250038 — Muscle Stimulator Device (PZ-100)
- K250122 — SleepRight Snore Aid
- K250390 — CloSYS® Dry Mouth Sensitive Mouth Rinse
- K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
- K250456 — Dentemp Pro-Comfort Dental Guard
- K240554 — InferRead Lung CT.AI
- K241581 — Hemodialysis Catheter
- K241671 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
- K242438 — Clearo
- K242569 — Mixed Reality Spine Navigation
- K242585 — Cystatin C
- K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
- K242731 — MasteRad MiniX Mobile Digital Imaging System (Mini-X)
- K243105 — Ruby Intravascular Catheter
- K243176 — BLESSING System
- K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
- K243602 — Arthrex Spine Endoscope
- K243617 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
- K243837 — iBSM
- K243927 — MobileLink Acetabular Cup System - inhouse coatings
- K244008 — Spectral CT
- K244033 — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
- K250086 — OTS Hip
- K250099 — Mobius3D (4.1)
- K250110 — Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);
- K250141 — Synthecure Synthetic Calcium Sulfate
- K250971 — Embosphere Microspheres
- K251184 — AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System
- K240857 — Youmagic FLM System (YM5-U1)
- K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
- K242176 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
- K242479 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
- K242518 — Hypertension Prediction Index (HePI) Algorithm
- K242519 — Lumify Diagnostic Ultrasound System
- K242931 — HFT750U
- K243165 — Limfa Therapy System (Limfa Therapy)
- K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
- K250276 — Nitinol Enhanced Device (NED)
- K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
- K250444 — NEXUS® Hip Stem
- K250451 — NeurAxis IB-Stim (01-1020)
- K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
- K251156 — NPseal
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
- K242072 — CeraRoot TL Implant System (TL)
Data sourced from openFDA. This site is unofficial and independent of the FDA.