FDA 510(k) clearances — page 405
clearances on record, most recent first.
Clearances — page 405
40,401–40,500 of 176,542- K122490 — KULAVAC
- K130853 — IDYS(TM) C
- K131128 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
- K131904 — MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA
- K132552 — U&U STERILE HYPODERMIC NEEDLE
- K133138 — BD Veritor System Flu A+B Assay
- K122410 — I RUNE (I-200L)
- K130066 — SPECTRUM SPINE SPINOUS PROCESS DEVICE
- K130848 — SHANGHAI PHOENIX MECHANICAL WHEELCHAIR
- K131243 — NON-CONTACT INFRARED THERMOMETER
- K132085 — ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
- K132102 — BECE CAD ZIRKON HT+
- K132106 — INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
- K132276 — STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
- K132294 — GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS
- K133226 — BIOGRAPH MMR
- K133265 — QUADROX-IR ADULT AND SMALL ADULT
- K130759 — HUMELOCK II CEMENTLESS SHOULDER SYSTEM
- K131533 — CAYMAN MI PLATE SYSTEM
- K122061 — K-Y BRAND LIQUIBEADS
- K130101 — BYTECH
- K130387 — ORTHOALIGN PLUS SYSTEM
- K131275 — MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
- K131767 — ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
- K131932 — APNEALINK PRO
- K132515 — LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
- K132545 — MEDIVALVE ACWIRE
- K132574 — PASS LP SPINAL SYSTEM
- K132913 — VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
- K131236 — UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
- K131240 — COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
- K131355 — CONCEIVE PLUS
- K131423 — G-ARM MULTISCAN SYSTEM
- K131839 — DC 7
- K131841 — KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
- K132006 — STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
- K132155 — Merit ASAPLP Aspiration Catheter
- K132222 — AQUILION ONE VISION, V6.0
- K132456 — BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
- K132799 — CLARISO PACS
- K113135 — UNISTRIP 1
- K130357 — SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
- K130405 — RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
- K130419 — PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
- K130978 — ZTX ULTRASONIC DIATHERMY DEVICE
- K131519 — BELMONT HYPERTHERMIA PUMP
- K132022 — LEMAITRE 8F OCCLUSION CATHETER
- K132048 — BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
- K122338 — PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
- K122400 — CARDIOX FLOW DETECTION SYSTEM
- K131211 — DICOMPACS DX-R WITH FLAT PANEL
- K131661 — INFUSION SYRINGE SET
- K132047 — LEMILLS VALVULOTOME
- K132241 — GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T
- K132297 — EM SINUS DILATION SYSTEM
- K132307 — VIDA LED SURGICAL LIGHTING SYSTEM
- K132561 — NURO NEUROMODULATION SYSTEM
- K132567 — ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN
- K131518 — MECTACER BIOLOX OPTION HEADS
- K131566 — ARIX HAND SYSTEM
- K131655 — LIGHTHOUSE(TM) URINARY CATHETER
- K131700 — SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
- K131834 — WOLF LONG BONE PLATE SYSTEM
- K133134 — X-PORTE ULTRASOUND SYSTEM
- K123514 — CLEARPATH ALIGNER
- K130195 — SCANNING LASERLINK
- K130649 — SILK ROAD ACCESS CATHETER
- K130845 — AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW
- K131420 — PETITE BASIC SYSTEM 701 ELT
- K131669 — PERIMETER INTERBODY FUSION DEVICE
- K131693 — RAYSCAN A-EXPERT
- K131695 — RAYSCAN A-EXPERT 3D
- K132109 — ENAMELAST
- K132124 — KLARITY VACUUM BAG, KLARITY MOLD CUSHION
- K132450 — CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND
- K132831 — QUIET/SILENT SCANNING SUITE
- K132883 — HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
- K122040 — INVOTEC LARYNGEAL ELECTRODE
- K123155 — LUNA DENTAL IMPLANT SYSTEM
- K130827 — FIRMAP CATHETER
- K131222 — AMPCARE ESP THERAPY SYSTEM
- K131748 — OSSEOFUSE DENTAL IMPLANT SYSTEM
- K131894 — NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
- K131914 — OFFROAD RE-ENTRY CATHETER SYSTEM
- K132014 — GSB GLOBAL SPINAL BALANCE SYSTEM
- K132209 — IPS E.MAX CAD ABUTMENT SOLUTIONS
- K132280 — ALTUS SPINE PEDICLE SCREW SYSTEM
- K132586 — PAXERAPACS
- K132705 — UNIQUE
- K132924 — MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
- K132995 — DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
- K122783 — PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
- K130534 — DIPLOMAT
- K130675 — ARTHREX UNIVERS II CA HEADS
- K130784 — SPIROTEL
- K131116 — U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
- K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
- K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
- K132025 — MESO BILAYER SURGICAL MESH
- K132166 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
Data sourced from openFDA. This site is unofficial and independent of the FDA.