FDA 510(k) clearances — page 3
clearances on record, most recent first.
Clearances — page 3
201–300 of 176,013- K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
- K261668 — Venue Go
- K261905 — BUM Oil
- K261937 — PacTemp Automix NE
- K262357 — Arthrex Bioabsorbable PushLock Suture Anchors
- K251508 — Telemetry Monitor (iT30, iT50)
- K253469 — Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM) +5 more
- K253999 — Universal Base ASC Engaging +6 more
- K254194 — QIAstat-Dx BCID GPF Plus AMR Panel
- K260223 — Aristotle Mini Guidewire
- K261059 — Overjet Multi-Image Caries and Charting Assist
- K261121 — Megalodon Dynamic Compression System
- K261571 — Manual Wheelchair (H008, PCK7)
- K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
- K252853 — CAD - Lower GI (EC07-01)
- K253858 — GFS - Sterile Screws and Top Hat
- K254211 — pVasc Net Mechanical Thrombectomy Device
- K260120 — NaturaJel Oral Wound Care Kit
- K260737 — Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16) +2 more
- K260845 — Huahong Sharps Container (HHR-I, HHR-II)
- K260919 — Transurethral Catheter Safety Valve (TUCSV) (80050)
- K261380 — Concentriq AP-Dx
- K261456 — Ruthinium Disc
- K261932 — Leksell® Vantage Stereotactic System
- K262056 — Rusch Latex Gold Foley Catheter
- K253760 — OMNI Ultra Surgical System (1-110)
- K253902 — RealGUIDE
- K254043 — TRIVANCE Hip Stem
- K260572 — Marrow Marxman
- K261496 — LED Light Therapy Masks (PE748, PE749, PE756)
- K261523 — Vertex Thrombectomy System
- K261609 — Freedom Partial Knee System
- K261851 — LED Light Therapy Mask (5 models)
- K261915 — Navigator Flex Ureteral Access Sheath Set
- K262311 — Alturion Series Diagnostic Ultrasound System
- K260236 — XLITE
- K260381 — Eve
- K261408 — SABER-XA System
- K261503 — PuraStat GI
- K261504 — PuraStat-RM
- K261856 — Halcyon, Ethos Radiotherapy System (5.0)
- K262047 — Grappler Suture Anchor System
- K262115 — VueJect® Ultrasound Enhancing Agent Delivery System
- K252812 — UniPearls® Embolic Microspheres
- K253555 — Flexitouch® Plus Advanced Pneumatic Compression System
- K253655 — Angled Screwdriver MED (M-SD090)
- K253800 — 0909FCE, 0909FCE-HS
- K253835 — Affinity
- K254042 — WatchPAT SW
- K260607 — Shield System (Siemens 30x40)
- K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure
- K260936 — RadioViewAI
- K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- K261187 — Hearing Aid Feature
- K261331 — I-Genius (100019400)
- K261335 — VitalFlow Set with Balance Biosurface
- K261451 — ZSAlign Cervical Interbody System
- K261482 — LightStim for Wrinkles (1984); LightStim for Acne (2038)
- K261494 — Smart Wireless Stethoscope (4 models)
- K261809 — Interwedge® Standalone Lateral
- K261810 — Vertiwedge® Intraosseous System
- K261824 — da Vinci Surgical System, Model IS5000
- K261854 — xvision Spine system
- K261912 — SnØreNegatØr
- K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)
- K262253 — Lantern Knee Navigation Unit (406000-03); Lantern Hip Navigation Unit (502000-03)
- K262681 — NanoCeram Resin
- K251959 — TnR Cranial Implant
- K252042 — Sync AV II Temporary Pacing Catheter
- K254038 — Motivista (CT-155)
- K260161 — SmartGuide Disposable Guides and Grids
- K260566 — SMARTVERTIGO Vestibular Assessment System
- K260620 — SeptAlign (SPLN001)
- K260624 — Arthrex Radial Head Replacement System
- K260980 — cmAngio® V2.0
- K261288 — Handheld Ultrasound Scanner
- K261389 — PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
- K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
- K261448 — neXus Ultrasonic Surgical Aspirator System
- K261835 — LOGIQ Focus
- K262239 — Obsidian® Press Over Zirconia
- K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
- K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down
- K251908 — Emanate Tray
- K253526 — NAMIC Dilator and Sheath
- K260588 — Cleerly LABS
- K261058 — CraniUS Plate
- K261205 — SPINEART Navigation Instrument System
- K261210 — Cleerly Plaque
- K261766 — CPS Locator 3D Plus Delivery Catheter
- K261770 — Suture Button Repair System
- K261829 — Profoject Dual-Safety Pen Needles
- K262200 — Stone Clear (BWSC-LP9-02)
- K262240 — SSPC NXT Delivery Catheter
- DEN250042 — CaRi-Heart
- K253450 — BodyTom Elite (NL4000)
- K253651 — Revi System
- K260303 — See-Mode Augmented Reporting Tool, Breast (SMART-B)
- K260326 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
- K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.