FDA 510(k) clearances — page 940
clearances on record, most recent first.
Clearances — page 940
93,901–94,000 of 175,890- K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
- K971679 — I-SCOPE OPHTHALMIC ENDOSCOPE
- K971841 — BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
- K962811 — SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION
- K963546 — SMF TITANIUM (TI) ALLOY BONE SCREWS
- K964595 — OPUS PSA TEST SYSTEM
- K964826 — POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION
- K964974 — MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE
- K965027 — VENTED I.V. SET
- K965192 — THAIRAPY VEST SYSTEM
- K970015 — ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
- K970102 — FILTER
- K970222 — LOW PROTEIN LATEX EXAMINATION GLOVES
- K970542 — MASTER NEB II
- K970551 — QUANTA LITE B2GPI IGG
- K970612 — SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
- K970855 — CLAVE CONNECTOR
- K970882 — ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
- K970918 — BROWNE STEAM INDICATOR
- K971126 — HYDROCOLLOID WOUND DRESSINGS
- K971129 — OXYPURE PORTABLE OXYGEN GENERATOR
- K971159 — SURGICAL DRAPES
- K971193 — LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM
- K971453 — ORTHOTEC K-CAP SYSTEM
- K971482 — DEGANIA SILICONE SIL-K
- K971483 — SECURE-WRAP (TM) STERILIZATION WRAP
- K971639 — PLUSTRON ION TOOTHBRUSH SYSTEM
- K971644 — CEBE
- K971685 — IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
- K971711 — SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR
- K971780 — THYROTROPIN(TSH) ELISA
- K971898 — PERMALUTE, TRY-IN PASTE
- K971907 — CALCIUM REAGENT
- K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA
- K971987 — SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
- K972014 — SUNGLASSES (NON-PRESCRIPTION)
- K972047 — KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE
- K972073 — TOTAL BILIRUBIN REAGENT
- K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
- K972174 — LYPHOCHEK REMEDI CONTROL
- K972194 — RIVIERA SUNGLASS4ES
- K972214 — ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
- K972232 — ABBOTT AXSYM FOLATE
- K970127 — EDOSSEOUS DENTAL IMPLANT
- K970752 — SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
- K971083 — ARTHROSCOPE
- K971149 — SVL-9130 DEFIBRILLATION ELECTRODE
- K971075 — PRIMED PRIME-PLUS COTTON GAUZE SPONGES
- K940954 — SYNAPTIC 3000
- K963932 — PRELOADED SOFT TISSUE ANCHOR
- K964206 — NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2
- K964688 — LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
- K964947 — PHOTON RADIOSURGERY SYSTEM (PRS)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.