FDA 510(k) clearances — page 366
clearances on record, most recent first.
Clearances — page 366
36,501–36,600 of 176,542- 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 +5 more
- 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 +1 more
- 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
- K142773 — EOS System
- K142932 — Deltex Medical KDP72 Doppler Probe
- K142945 — Sonoma Fibula Repair System
- K143247 — Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)
- K143718 — Mammography Color Display DP-M3010
- K140706 — LEVO MAX
- K141599 — DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
- K141707 — ULTRASKIN HYDROPHILIC GUIDE WIRE
- K142025 — NEUROLUMEN PN-1000
- K142104 — NANOFUSE DBM
- K142107 — ECHO TRUE 3D VIEWER
- K142360 — Everest Spinal System
- K142572 — Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
- K142678 — Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
- K142791 — Spectra Soft Tissue Biopsy Needles
- K142860 — Lumenis M22 System
- K142866 — Myoscience iovera system
- K143065 — NuVasive ALIF Buttress Plate System
- K143299 — Percuvance(R) Percutaneous Surgical System
- K143366 — ADVANCE Porous Coated Spiked Tibial Base
- K140037 — OPTIMUS CMF SYSTEM
- K140736 — STERISAFE HP TABLE-TOP STEAM STERILIZER
- K140898 — PATIENT SPECIFIC DISTAL FEMORAL
- K142109 — STERILUCENT STERILIZATION CONTAINER SYSTEM
- K142155 — ENDOCHOICE WATER BOTTLE CAP SYSTEM
- K142825 — Zmachine
- K142838 — Synapse Occipital-Cervical-Thoracic (OCT) System
- K143037 — SnapShot Fixation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.