FDA 510(k) clearances — page 786
clearances on record, most recent first.
Clearances — page 786
78,501–78,600 of 176,637- K012916 — FRONTIER ANTERIOR SCOLIOSIS SYSTEM
- K012918 — APEX MODULAR ALUMINA FEMORAL HEAD
- K013145 — WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
- K013266 — RUSCH POLYFLEX STENT KIT
- K013731 — GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
- K013810 — CARDIOVASCULAR ARRAY
- K011192 — COMPRESSIBLE LIMB SLEEVE
- K012881 — C3 ANTERIOR CERVICAL PLATE SYSTEM
- K013075 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K013136 — ANEURYSM CLIPS
- K013180 — RAPIDONE-ECSTASY TEST
- K013711 — BACTI-SWAB DRY
- K013796 — LIVESURE METHADONE SCREEN TESTS
- K010579 — STENT SUPPORT GUIDE CATHETER
- K010596 — RUSCH BRONCHUS BLOCKER KIT
- K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
- K011487 — CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS
- K012854 — RENAL GUIDING SHEATH
- K012877 — HIGH GOLD PALLADIUM FREE CERAMIC SOLDER
- K013083 — CARTO XP EP NAVIGATION SYSTEM
- K013546 — MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
- K013564 — MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
- K013565 — CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
- K001879 — INFUSION IV SET
- K011561 — SEREINE EXTRA STRENGTH DAILY CLEANER
- K011963 — ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
- K012164 — 'RAPIDONE'-METHADONE TEST
- K012817 — HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
- K012818 — HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
- K012830 — LERMAN & SON CRANIAL ORTHOSIS HELMET
- K012841 — DUO PAL 6, ORDER-NO.: 2154
- K012846 — ZIPPY, MODEL I88WA
- K012872 — RESORBABLE SCREW ANCHOR
- K012875 — SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
- K012910 — THE BIOPLATE MANDIBLE FIXATION SYSTEM
- K012944 — POWER DRIVE
- K013068 — BIOSCANNER 2000
- K013081 — MEDSTAR 150
- K013220 — HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
- K013232 — CYBERCASES BY BAUSCH & LOMB
- K013239 — COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
- K013265 — VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
- K013332 — LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE
- K013368 — HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K013467 — TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
- K013469 — EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR
- K013508 — HRH-127-ALLEGRA HEAD ARRAY COIL
- K013540 — EBI XFIX ACCESS PELVIC FIXATOR
- K013550 — CLIRANS E-SERIES DIALYZER
- K013566 — IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
- K013602 — HNC-63-INT NEUROVASCULAR ARRAY COIL
- K013631 — EFILM VIDEO
- K013782 — DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
- K011322 — DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE
- K012236 — STARS2000 POWER CANNULA
- K012806 — CYNOSURE PHOTOGENICA VL
- K012850 — RECORDING AND STIMULATING ELECTRODE
- K012873 — DOCUMENTING LASER SLIT LAMP, DP 2010
- K012929 — FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
- K013227 — SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT
- K013437 — SF SH CATHETER, MODEL R65-945
- K013491 — HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
- K010601 — FANELLI BILIARY STENT
- K011121 — RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
- K011122 — BALLPEN SPINAL NEEDLE W/WO INTRODUCER
- K011473 — SNAZZY2
- K011556 — MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
- K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
- K012197 — POWERHEART CARDIAC RHYTHM MODULE
- K012585 — AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
- K012773 — DISCOVERY FACET SCREW FIXATION SYSTEM
- K012774 — JOSTRA ARTERIAL PERFUSION CANNULAE
- K012776 — DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
- K012785 — TWINTRODE ELC 134 ELECTRODE
- K012790 — CYNOSURE PHOTOGENICA ER
- K012798 — INTEX SCREW
- K012819 — SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
- K012833 — INTUITIVE SURGICAL BIPOLAR FORCEPS
- K012853 — SMART GLOVE STERILE NITRILE EXAM GLOVE
- K012856 — STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G
- K012880 — STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
- K012896 — STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS)
- K013082 — MEDSTAR 100 INTERFERENTIAL STIMLATOR
- K013095 — WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
- K013101 — WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
- K013119 — VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
- K013203 — BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
- K013206 — TINA-QUANT APOLIPOPROTEIN B VER.2
- K013249 — TINA-QUANT APOLIPOPROTEIN VER.2
- K013274 — MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
- K013440 — ISOBAR SPINAL SYSTEM
- K013441 — ISOLA POLYAXIAL WASHER
- K013444 — ISOBAR SPINAL SYSTEM
- K013468 — LONG LENGTH DYAX NAIL
- K013480 — COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
- K013499 — DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
- K013503 — MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
- K013557 — LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
- K013627 — SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM
- K013709 — HILL-ROM PRIMAVIEW MONITOR SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.