FDA 510(k) clearances — page 358
clearances on record, most recent first.
Clearances — page 358
35,701–35,800 of 175,770- K131335 — BWMINI EEG, BWMINIHST, BWMINI PSG
- K140575 — ENGSTROM CARESTATION, ENGSTROM PRO
- K141666 — FERTILIGENT SLOW RELEASE IUI CATHETER KIT
- K141945 — ECHOSTAR COMFORT 1.5T MRI
- K142459 — Ebony PTA 0.014 RX Peripheral Dilatation Catheter
- K142767 — ThinkMed Intermittent Catheter with/without Hydrophilic Coating
- K142894 — TCS Blend
- K143200 — MIS Z-Pedicle Screw System
- K143362 — extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
- K143563 — Infusion Aspiration Catheter System
- K142242 — PREMIUM, SHELTA Implant Systems
- K133891 — MULTIPULSE TM+1470
- K140852 — VECTRAPLEX CMS
- K140861 — SOMNOTOUCH RESP
- K141189 — NANOBONE / GRANULATE
- K141354 — NAVAJO PTA BALLOON DILATATION CATHETER
- K141548 — HIGH TIBIAL OSTEOTOMY SYSTEM
- K141751 — ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
- K141986 — ELUX 810 LASER
- K142273 — EmboGuide
- K142957 — Ideal pedicle screw spinal system
- K143171 — FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
- K143178 — FilmArray 2.0 System
- K143179 — The LINK® Endo-Model® Knee System
- K143232 — Universal Digital Interface 2W, UDI 2W
- K143543 — Prelude PF Patellae
- K143633 — CREO Stabilization System
- K134051 — TRANSONIC ELSA SYSTEM
- K141210 — QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
- K142246 — LightStim for Acne/ LightStim for Acne Mini
- K142500 — One Way Soft Valve
- K142656 — Surgical Gut Suture
- K142714 — S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
- K142837 — HEINE SIGMA 250 & HEINE SIGMA 250 M2
- K142989 — Mini ONE Enteral Extension Set
- K143129 — easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)
- K143155 — LISTERINE Sensitivity Defense Mouthrinse
- K143199 — Capillus 272 Pro
- K143281 — Ultimax-i
- K143452 — LOGIQ P9, LOGIQ P7
- K133733 — WINSIX Implant System
- K141400 — DCCERAM SYSTEM
- K141892 — QK-SYSTEMIC THERAPEUTIC APPARATUS
- K142815 — S22 Digital Color Doppler Ultrasound System
- K142940 — Endoskeleton TCS System
- K143113 — Klassic BiPolar System
- K143691 — LDLC3 LDL-Cholesterol Gen.3
- K141634 — NAUTILUS DELTA
- K142249 — SCHOELLY SINUSCOPE
- K142625 — PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)
- K142743 — AliveCor Heart Monitor
- K142889 — Celerity PICC Tip Confirmation System
- K142929 — Ligasure Blunt Tip Sealer/Divider
- K143063 — Stryker SonicPin System, Stryker SonicAnchor System
- K143187 — Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
- K143426 — Wound Matrix TF
- K143509 — MasterSL femoral stem
- K143680 — ADVIA Centaur IgE Master Curve Material
- K141685 — CROC
- K141980 — LEVA (TM) SPACER SYSTEM
- K142201 — OMNI Interface Acetabular System
- K142222 — NewTom 5G
- K142237 — Aviator Anterior Cervical Plate (ACP) System
- K142284 — CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
- K142321 — Benchmark Intracranial Access System
- K142491 — ZEL TIQ CoolSculpting System
- K142606 — Trident® Tritanium® PST® Acetabular Shells
- K142655 — CB PROT II Posterior Spinal System
- K143059 — TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)
- K143061 — Activ Ankle Locking Plating System
- K143124 — KA01 Chitosan Wound Dressing
- K143151 — Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)
- K143163 — AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System
- K143490 — VERTA Corpectomy Cage
- DEN140038 — Dexcom Share Direct Secondary Displays
- K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
- K133729 — WOUND DRESSING WITH MANUKA HONEY
- K140265 — ELECTRODE FOR URINARY INCONTINENCE
- K140932 — AMSEL OCCLUDER DEVICE
- K141142 — MAMMAPRINT FFPE
- K141448 — TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
- K141511 — SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
- K141722 — CAREFUSION GOLD TISSUE MARKER
- K141830 — STIMULAN KIT, STIMULAN RAPID CURE
- K142030 — STGC-LORDOTIC
- K142207 — TransferMan 4m Micromanipulator
- K142348 — OsteoSeal Bone Hemostat
- K142552 — A7 Anesthesia System
- K143000 — RIS500
- K143159 — Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS
- K143392 — Quattro Bolt Tenodesis Screw
- K143394 — Acumed Small Fragment Base Set
- K143396 — omni TRAX Active Patient Tracker
- K143460 — Cannulated Screw System
- K143571 — Audit MicroControls Linearity LQ Cystatin-C
- K143639 — IMMULITE 2000 CEA Calibration Verification Material
- K143751 — Visi Mobile Monitoring System
- K133959 — PODIATRY X-RAY SYSTEM
- K133985 — DIGITAL ELECTROCARDIOGRAPH
- K140547 — EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.