FDA 510(k) clearances — page 26
clearances on record, most recent first.
Clearances — page 26
2,501–2,600 of 176,479- K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
- K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K252984 — Perin Health System (PHD80060-2)
- K253057 — AI-Rad Companion Brain MR
- K253253 — IPDmilled Blanks
- K253315 — Straumann Variobase Abutments XC for Bridge/Bar
- K253498 — Pump In Style® Pro+
- K253652 — Genie MAX Large Bore Introducer Sheath
- K253735 — AV Vascular
- K251281 — Nova Max Creat eGFR Monitoring System
- K251286 — Affirm 400
- K251385 — InQwire Super Stiff Guide Wire (6 models)
- K252369 — Boston Pico755
- K252977 — Halcyon, Ethos Radiotherapy System (5.0)
- K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System
- K253730 — RoVo Mechanical Thrombectomy System
- K254165 — Infinity OCT System
- K260170 — LumiCera
- K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
- K251318 — VariFuse Adjustable Infusion Catheter
- K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G +1 more
- K252537 — Rusch SoftSimplastic Foley Catheters
- K253173 — uCT 780 with uWS-CT-Dual Energy Analysis
- K253291 — Excelsior System
- K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
- K253698 — Milex Incontinence Dish Pessaries +3 more
- K253998 — Clearview Intracoronary Shunts
- K254085 — CARTO 3 EP Navigation System V9.0 with PIU Plus
- K254114 — Baylis Connector Cable
- K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
- K253363 — NeuroSpan Bridge
- DEN250005 — Sana Device
- K250135 — WAVE Clinical Platform (2.0.000)
- K251249 — Tru Hematology Test
- K251341 — VITAL Tubing Sets for Hemodialysis
- K251353 — Eyer 2
- K251367 — OptoMonitor 3
- K251448 — FL-10000U Respiratory Humidifier
- K251714 — Ion-C
- K251721 — Xpert GI Panel
- K251739 — da Vinci Surgical System (IS5000)
- K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter
- K251790 — SeptAlign
- K251900 — MY01 Continuous Compartmental Pressure Monitor
- K251934 — qXR-Detect
- K252205 — Curiteva Porous PEEK Cervical Interbody System +3 more
- K252297 — Toro 88 Superbore Catheter
- K252634 — Imagine® Enterprise Suite
- K252767 — actiTENS mini
- K252775 — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea) +3 more
- K252960 — SOLIUS PRO UVB Light Panel
- K253082 — LZI Buprenorphine II Enzyme Immunoassay
- K253408 — CoolTone
- K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
- K254126 — Natrelle 133S Tissue Expanders
- K254186 — Azurion R3.1
- DEN250009 — VitaSmart Hypothermic Oxygenated Perfusion System
- K251254 — Ignite RF System
- K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
- K251357 — Esperance pHLO Aspiration System
- K251458 — Electric Wheelchair (DH01168)
- K251831 — Bio-Medicus Life Support Catheter and Introducer
- K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
- K251961 — SDS Growing Rod
- K252188 — EMLA (6 models)
- K252283 — Nano-Check Influenza A+B Test
- K252516 — N22 EZ Glenosphere
- K252567 — AltiVate Reverse® ADLC Glenosphere
- K252934 — Diagnocat
- K253023 — BIOGRAPH One
- K253171 — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
- K253276 — Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)
- K253470 — MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
- K253925 — Aventus Thrombectomy System
- K254002 — TriMed Volar Bearing Plates (6 models)
- K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System
- K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP
- K251996 — ENTire IRE System
- K252219 — Cervical Interbody and VBR Fusion System
- K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff
- K252579 — Orthoscan TAU MVP Mini C-Arm System
- K252958 — METICULY Patient-specific titanium mesh implant
- K253511 — Concerto Versa Detachable Coil
- K253585 — SmartGuard technology; Predictive Low Glucose technology
- K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
- K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
- K251214 — BEAR® (Bridge-Enhanced ACL Restoration) Implant
- K252461 — Swedge Pedicle Screw Fixation System Bezier Rod
- K252549 — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid +1 more
- K253248 — Bright Cavity Liner
- K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) +1 more
- K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K250890 — SBC1 Cream
- K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
- K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
- K251389 — High speed air turbine handpiece
- K251524 — Dr. Yglo Skin Tag Remover
- K251558 — Precision AI Surgical Planning System (PAI-SPS)
- K251701 — Star E900 Electric System
- K251886 — EmpowerRide NAVIGATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.