FDA 510(k) clearances — page 43
clearances on record, most recent first.
Clearances — page 43
4,201–4,300 of 176,479- K251759 — Flexiva Pulse Laser Fiber +3 more
- K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
- K241525 — ExcelsiusXR
- K250065 — DENSITY; DENZA; DENSITY Noir
- K250342 — Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
- K250695 — Single-use Ureteral Access Sheath
- K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
- K251741 — PathLoc Lumbar Interbody Fusion Cage System
- K251761 — Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode
- K251766 — TumorSight Viz
- K251776 — EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)
- K251804 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K243884 — TAVIPILOT
- K250496 — Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
- K250827 — aprevo® anterior lumbar interbody fusion device +7 more
- K251502 — TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
- K251863 — CustomSurg OrthoPlanner
- K243123 — IPL Treatment Device (MDSQMC-01)
- K243207 — BD Vacutainer® Eclipse Blood Collection Needle
- K243220 — Onera STS 2 (ONERA STS 2)
- K243255 — URIS Long Implant & Abutments
- K243280 — Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
- K243678 — TalisMann Neuromodulation System
- K243679 — MammoScreen® (4)
- K243826 — SMR Reverse HP Shoulder System
- K250105 — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
- K250165 — Pastelle
- K250286 — Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
- K250398 — Innovita Flu A/B Antigen Rapid Test
- K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit
- K250733 — 3DOSE 1ml Syringe
- K250822 — SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
- K250838 — Denudation Pipettes
- K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips
- K251080 — IdentiTi II Cervical Interbody System
- K251291 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- K251390 — MTA vpt
- K251528 — syngo.via MI Workflows; Scenium; syngo MBF
- K251599 — Single-use Ureteral Access Sheath
- K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
- K243399 — Boehringer Laboratories Liver Retractor
- K243468 — Compressor Nebulizer (4 models)
- K243701 — AuroLase® System
- K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K250279 — RC-SwiftPrep
- K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
- K250391 — Leksell Gamma Knife® (3 models)
- K250415 — G0 Blood Pressure Monitoring System (G0)
- K250524 — Mendaera Guidance System
- K250587 — Orthoscan TAU Mini C-Arm
- K250684 — OPUSWAVE Dual Sensor Imaging System
- K250729 — Power Wheelchair (MOB1107)
- K250779 — CS-Pro MED
- K250848 — Identity Shoulder System
- K251031 — Fiber Laser Treatment Systems (HS-232,HS-233)
- K251049 — SurgiLight 1470 Diode Laser System (Model:Halo)
- K251241 — EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)
- K251285 — Electric Wheelchair (HG-630)
- K251490 — 8 mm Assist Cannula; 12 mm Assist Cannula
- K251720 — OsteoFlo HydroFiber
- K251746 — Pure Impact
- K243485 — Alinity m CMV
- K243690 — SonoMSK
- K243779 — Bunkerhill Abdominal Aortic Quantification (AAQ)
- K250016 — droplet® personal lancets
- K250096 — Felix NeuroAI System
- K250204 — Endoscopic Camera System
- K250221 — StrokeSENS ASPECTS Software Application
- K250699 — Cure Twist Female 8 Catheter (T8) +9 more
- K251032 — MiniMed 780G insulin pump
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
- K251453 — Arthrex iBalance Partial Knee System
- K251719 — Momentum® Posterior Spinal Fixation System
- K251933 — SnugFit ASA Extension
- K243647 — Synapse PACS (7.5)
- K250022 — HeroTracker Sense
- K250484 — PIUR tUS inside
- K250670 — EchoConfidence (USA)
- K250987 — aprevo® posterior/transforaminal lumbar interbody fusion device
- K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
- K251000 — Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
- K251088 — Otsuka Digital Feedback Device
- K250972 — Primum Hydrophilic Guiding Catheter
- K242988 — Genostis Osteosynthesis System
- K243077 — Affirm 800
- K243130 — Integral Dental Unit
- K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
- K243183 — RTMsense Respiratory Monitoring System
- K243187 — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
- K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN
- K243388 — Disposable Distal Cap
- K243682 — SonoPlex STIM; SonoPlex II
- K243816 — Testa TP Pivoting Spacer System
- K243900 — eMotus Respiratory Motion Management System
- K250310 — VIKING Fixed Curve Diagnostic Catheter
- K250522 — Multi4 System
- K250585 — LumenaTM Ureteral Access Sheath
- K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
- K250648 — Philips iCT CT system
- K250828 — CPS Locator 3D Plus Delivery Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.