FDA 510(k) clearances — page 642
clearances on record, most recent first.
Clearances — page 642
64,101–64,200 of 176,637- K060170 — ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
- K060183 — ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER
- K051295 — I-D GLIDE
- K052204 — THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER
- K052321 — VERSYS EPOCH FULLCOAT HIP PROSTHESIS
- K052833 — GORE-TEX NON-STERILE SURGICAL GOWNS
- K052882 — FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE
- K052954 — CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET
- K053212 — RAVEN PROPACT
- K053329 — KORLEX-GR GINGIVAL RETRACTION PASTE
- K053352 — COMFORTLITE NASAL MASK
- K053389 — AESCULAP STERILCONTAINER SYSTEM
- K053391 — X-TRA FIL
- K053566 — MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
- K053575 — HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
- K060131 — OSS-BODIES PROXIMAL TIBIAL SLEEVE
- K053099 — BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
- K053387 — PERIOGLAS BONE GRAFT PARTICULATE
- K053523 — POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
- K060042 — LANDLEX, MODEL P100X
- K060123 — LEVELERT II FLUID LEVEL SENSOR
- K052797 — LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM
- K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
- K052966 — CI KNEE, CI MI TKR
- K053070 — CONTOUR II SPINAL SYSTEM
- K053316 — REPROCESSED COMPRESSION SLEEVES
- K053508 — SYNFIX-LR
- K053608 — CYNOSURE PHOTOGENICA V-STAR LASER
- K053657 — POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
- K060081 — BASIS SPINAL SYSTEM
- K060130 — IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
- K060144 — SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
- K060194 — MARCH HEALTHCARE HEALTH MONITORING KIT
- K060203 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K051961 — WWMED, MODEL 401
- K052594 — WILLCARE, MODEL GW-1020
- K052983 — FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES
- K053216 — HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
- K053602 — PROCERA SOFTWARE, MODEL 33145
- K060095 — MODIFICATION TO: VACLOK SYRINGE
- K060210 — MEDIPORT
- K060211 — WUZHOU SYRINGE, WITH/WITHOUT NEEDLE
- K052591 — NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
- K052858 — SOOTHIES GEL PADS
- K053032 — ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000
- K053127 — IPLAN
- K053603 — C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
- K053644 — THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
- K060083 — NRBC-CHEX FOR LH
- K060220 — PBS MODEL 701A COMPRESSION THERAPY DEVICE
- K050806 — OPTECURE
- K052125 — CARBONAID GAS DIFFUSER
- K052281 — EMBRACE WETBOND CLEAR SEALANT
- K052499 — DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS
- K053429 — ADVANCED UROLOGICAL CATHETER
- K053592 — SIMPLANT DR. JAMES
- K053618 — INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
- K060079 — KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
- K060080 — DIAGNODENT 2190 WITH PERIODONTAL PROBE
- K060179 — BIO-RAY SDX DIGITAL X-RAY SYSTEM
- K052439 — AESKULISA GLIA A AND AESKULISA GLIA G
- K052793 — IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02
- K053058 — XLTEK NEUROPATH, MODEL PK1070
- K053426 — ROCHE ELECSYS ANTI-TG
- K053576 — DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
- K060041 — TRIMED BONE PLATES
- K060055 — KODAK PACS
- K060084 — LYSUS INFUSION SYSTEM
- K060142 — VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
- K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
- K051699 — SEJOY, MODEL MT-403
- K052162 — SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT
- K053061 — EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- K053094 — ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056
- K053361 — MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
- K053390 — COLUMBUS (CR) TOTAL KNEE SYSTEM
- K053627 — MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
- K060107 — MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
- DEN060008 — INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET
- K042114 — MDL SERIES DIODE LASERS, MODEL MDL-10/15
- K043587 — SUCRALFATE AND CARAFATE PASTE KITS
- K050516 — T-SLING
- K050668 — GRT LITE, MODEL 8-A
- K051217 — DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)
- K051288 — VIELLE LUBRICANT
- K052546 — AEGIS ANTERIOR LUMBAR PLATE SYSTEM
- K052671 — HOCA EZ-CARE BP108, TENDER-CARE BP109
- K052696 — COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING
- K052796 — COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
- K053006 — ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II
- K053204 — INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A
- K053205 — RES TRAXX DATA CENTER
- K053240 — DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES
- K053301 — CEDARA I-RESPONSE CEDARA PET/CT
- K053371 — AMS MALE TRANSOBTURATOR SLING SYSTEM
- K053411 — DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
- K053461 — EZLOC FEMORAL FIXATION DEVICE
- K053473 — MAESTRO MDTL LASER SYSTEM
- K053500 — FRAMELESS RADIOSURGERY COMPONENTS
- K053533 — IMMULITE/IMMULITE 1000 TURBO INTACT PTH
Data sourced from openFDA. This site is unofficial and independent of the FDA.