FDA 510(k) clearances — page 7
clearances on record, most recent first.
Clearances — page 7
601–700 of 176,428- K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
- K251544 — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)
- K252571 — mdprostate
- K253453 — Metrix COVID Test; Metrix COVID Test Pro
- K253505 — Zamenix P
- K253554 — Aperio GT 450 DX; Aperio GT 180 DX
- K253561 — Aperio iQC DX Software
- K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)
- K254205 — Zenition 30
- K260567 — EW10-EC02 Endoscopy Support Program
- K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- K261362 — Xpert Hemorrhagic Fever
- K261437 — Mistral-Air® Warming System
- K261563 — Freedom Total Knee System (E-Poly Tibial Liners)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.