FDA 510(k) clearances — page 700
clearances on record, most recent first.
Clearances — page 700
69,901–70,000 of 175,825- K033969 — ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
- K033997 — SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
- K040024 — SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29
- K040038 — CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G
- K040098 — VARNISHAMERICA
- K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
- K032862 — INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
- K033036 — BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
- K033522 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
- K033784 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML
- K033889 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE
- K033924 — LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
- K030849 — AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
- K032531 — CHASE CARDIAC ANALYSIS SYSTEM
- K032628 — PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF
- K033419 — STV PRO 2
- K033506 — COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
- K033538 — BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8
- K033608 — AQUIFY MULTI-PURPOSE SOLUTION
- K033656 — SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE
- K033662 — SYNERGY SPINE ARRAY COIL
- K033808 — GRADIA GUM
- K033825 — ORTHOPACS
- K033828 — CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406
- K040046 — MINXRAY, MODEL HF120/60H POWERPLUS
- K040057 — MOBILE COMPACT DIGITAL CARDIAC CAMERA
- K020983 — JOSTRA SUCKERS, MODEL JS
- K030523 — WATERLASE
- K030864 — VADI MANUAL RESUSCITATOR
- K032199 — ESA PLASMA FREE METANEPHRINE ANALYSIS KIT
- K032765 — STREET
- K033055 — GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
- K033056 — BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
- K033058 — CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
- K033182 — PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
- K033590 — ERBE HELIX HYDRO-JET
- K033606 — ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST
- K033651 — OLYMPUS VIDEO URETEROSCOPE, NTSC
- K033757 — MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
- K033796 — KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
- K033811 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
- K033910 — OLYMPUS URINE CALIBRATOR
- K033939 — FLOSENSE II, MODEL 29-8040
- K034022 — UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES
- K034061 — MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
- K034062 — CP SLEEVE AND RIVER SLEEVE
- K034064 — FRESENIUS ULTRAFLO HPX HEMODIALYZER
- K040115 — PICCOLO MAGNESIUM TEST SYSTEM
- K040141 — EMORY CARDIAC TOOLBOX VERSION 2.6
- K030418 — MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
- K030655 — HOLOTC RIA
- K032214 — MEDONIC CA620/530 HEMATOLOGY ANALYZER
- K033120 — SCALETRON PIEZO ULTRASOUND SCALER
- K033500 — BD CAREFLOW CENTRAL VENOUS CATHETER
- K033938 — CLEARFIL PROTECT BOND
- K034058 — SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
- K040114 — ABBOTT DATA PORT PC, MODEL 12181
- K023713 — SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
- K031167 — HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
- K032141 — SECUMAX BLOOD COLLECTION SYSTEM
- K032235 — MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
- K032263 — 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
- K032882 — RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100
- K033349 — AC-1 SP02 ADAPTOR CABLE, MODEL AC-1
- K033447 — CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
- K033456 — EVOLVE RADIAL PLATE
- K033530 — ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
- K033532 — ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
- K034037 — SKY BONE EXPANDER SYSTEM
- K040060 — SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS
- K032514 — AC APPLICATOR, AURORA AC
- K033381 — DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
- K033508 — PLUS PIVOT LINK UNIVERSAL SYSTEM
- K033621 — NDI PASSIVE SPHERES
- K033772 — SHIRAZ-JAVA SPINAL FIXATION SYSTEM
- K040044 — HEEL SNUGGLER, MODEL 99047
- K032112 — P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
- K033302 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
- K033309 — PREMIER IMPLANT CEMENT, MODEL 3001450
- K033779 — VIANOX DELIVERY SYSTEM, MODEL II
- K030598 — MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
- K030780 — NEWPORT E500 WAVE VENTILATOR
- K031367 — DUOPATH VEROTOXINS GLISA TEST
- K031809 — PERIO PROTECT TRAY
- K032667 — FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)
- K033193 — SONOSENS
- K033667 — CARRARA PRESS SYSTEM
- K033686 — PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
- K033760 — ONE COAT SE BOND
- K022908 — POSTERIOR CABLE SCREW
- K024252 — MATCH MASTER LOW FUSION PORCELAIN
- K030876 — CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM
- K031621 — HERO 1, MODEL LY-ESB220
- K031841 — SPACER G TEMPORARY HIP PROSTHESIS
- K032101 — POWERSTAND STAND-UP WHEELCHAIR
- K032692 — DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368
- K033019 — SUNPEX TECHNOLOGIES MODEL SE03
- K033403 — T.S. MEDICAL CIRCUMCISION CLAMP
- K033515 — HUBERPRO SAFETY HUBER INFUSION SET
- K033835 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.