FDA 510(k) clearances — page 948
clearances on record, most recent first.
Clearances — page 948
94,701–94,800 of 176,637- K965065 — TECA. MILLENNIUM
- K970049 — BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/
- K970513 — GENERAL PURPOSE TRANDUCER COVER
- K970514 — DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE
- K970515 — GENERAL PURPOSE LATEX TRANSDUCER COVERS
- K970680 — GLORY
- K970707 — ELECT II BLOOD GLUCOSE MONITORING SYSTEM
- K970771 — SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
- K970916 — H.V. PULSE LAVAGE (L31 SERIES)
- K971047 — FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
- K971055 — DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
- K971072 — CHOLESTEROL REAGENT
- K971245 — BLINK EXTERNAL EYELID WEIGHT
- K971246 — LEO 7000 QUADRATURE KNEE COIL
- K971290 — STRATASYS FDM MEDMODELER SYSTEM
- K971296 — TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05
- K971324 — TRIGLYCERIDES, TG, OR TRIG
- K971614 — QUANTA LITE RF IGM
- K971621 — RESISTICK SOLID LAPAROSCOPIC ELECTRODES
- K971622 — MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
- K971714 — NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO
- K971774 — NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION
- K971842 — COAXIAL NEEDLE
- K971909 — VIRGO AMA ELISA KIT
- K972033 — PLANMECA INTRACAM
- K964015 — INDICARD TEST
- K964509 — IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
- K964650 — TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
- K964942 — INFECTION CONTROL CARTRIDGE
- K965222 — MICROJECT MODEL PCA-1
- K971547 — PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS
- K972072 — SURGITRON MODEL FFPF-EMC
- K964019 — MORPHEE PLUS ALPHA
- K964373 — SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT
- K964374 — SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT
- K970149 — LEGIONELLA ELISA TEST SYSTEM
- K970809 — BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL
- K971010 — PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
- K971020 — LSF TRIAD TOTAL HIP SYSTEM
- K971059 — UNIVERSAL DRIVE SYSTEM
- K971289 — SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
- K971573 — N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
- K971577 — FOCUS-PV BALLOON DILATATION CATHETER
- K971725 — OPUS PROGESTERONE
- K971978 — GRAFT HARVESTING SAWBLADES
- K972080 — QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3
- K972161 — BOVIE MODEL X15
- K962312 — KEY CHAIN EMERGENCY AIRWAY
- K963920 — 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
- K964818 — ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION)
- K965041 — OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
- K965042 — MICRODL DIARYCARD SPIROMETER
- K970083 — DYNABITE HOT GI BIOPSY FORCEPS
- K970887 — BLOOD FLOW ANALYZER
- K970992 — PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
- K971024 — SOFTSCAN
- K971031 — AUDALLION III HEARING SYSTEM
- K971032 — DANAVOX MODELS 163/162 BTE
- K971065 — DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES
- K971291 — HEARTPORT ENDOARTERIAL RETURN CANNULA
- K971379 — TINAQUANT RHEUMATOID FACTOR ASSAY
- K971428 — COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
- K971439 — STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
- K971449 — VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
- K971908 — CREA OR CREATININE
- K971967 — BUN
- K971976 — DIASCREEN REAGENT STRIPS
- K961634 — NIL - POWDER-FREE LATEX EXAMINATION GLOVES
- K964264 — HIGH RANGE PEROXIDE TEST STRIP
- K964295 — N-ASSAY TIA TRANSFERRIN TEST KIT
- K964368 — ELECSYS CEA ASSAY
- K964724 — POWDER-FREE LATEX EXAMINATION GLOVES
- K965044 — GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
- K970131 — ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE
- K970150 — MYCOPLASMA IGG ELISA TEST SYSTEM
- K970991 — DATEX ENGSTOM MANUAL RESUSCITATOR
- K971053 — ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS
- K971111 — TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER
- K971162 — LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
- K971190 — N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
- K971247 — SNT DISPOSABLE BIOPSY NEEDLE
- K971276 — GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
- K971405 — SPECIALITY URINE 1,2
- K971467 — SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
- K971709 — TOTAL THROXINE MICROPLATE EIA(225-300)
- K971779 — TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
- K971823 — ACTIVE TESTOSTERONE EIA (DSL-10-4000)
- K971902 — ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
- K971952 — LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
- K972004 — ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
- K925501 — NYLON COATED SPECULA
- K961779 — MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
- K961787 — BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
- K962597 — LXN FRUCTOSAMINE TEST SYSTEM
- K963349 — DEVILBISS 8650D
- K963575 — HBF-1000 OMRON BODY COMPOSITION ANALYZER
- K964025 — MITAYA ALUMINUM INTERSPACED X-RAY GRID
- K964507 — ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
- K964785 — VERIDOSE DIODES
- K970507 — PEAK FLOW METER
Data sourced from openFDA. This site is unofficial and independent of the FDA.