FDA 510(k) clearances — page 565
clearances on record, most recent first.
Clearances — page 565
56,401–56,500 of 176,542- K080745 — GENADYNE A4 POWERED SUCTION PUMP
- K080780 — ANCHORAGE SCOPE, MODEL 000003
- K080832 — STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
- K080896 — PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
- K080995 — MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
- K081113 — COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
- K081244 — LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS
- K081429 — THD SLIDE
- K081466 — STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K081698 — MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
- K081836 — CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
- K081879 — SPSMEDICAL SPORVIEW PA CULTURE SET
- K073089 — LIFEPAK 20E
- K080426 — MAESTRO WRIST FRACTURE IMPLANT
- K080939 — SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
- K081112 — FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
- K081238 — REPROCESSED MASIMO PULSE OXIMETER SENSORS
- K081294 — ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
- K081524 — SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L
- K081630 — MAMMO WORKSTATION
- K081678 — CONMED BEAMER SYSTEM C600
- K081760 — RSVP PHANTOM PELVIS, MODEL TLP260
- K081964 — K450 POWERED WHEELCHAIR
- K073382 — PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
- K080092 — ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
- K080178 — VALVULOTOME BY KOVEN
- K080220 — PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE
- K081129 — ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL
- K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
- K081176 — FLOCHANNEL
- K081206 — HOMELOX
- K081233 — T-STAT 303 ISCHEMIA MONITORING SYSTEM
- K081430 — ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING
- K081497 — OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)
- K081561 — OSFERION D
- K081583 — CLEARFIL SA CEMENT
- K081976 — IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
- K082014 — STRYKER SPINE AVS PL PEEK SPACERS
- K073249 — SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
- K080292 — EPICOR ABLATION SYSTEM
- K080468 — LIASYS WITH MODELS LIASYS
- K080664 — RELIEVE LAMINOPLASTY FIXATION SYSTEM
- K080848 — ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
- K080849 — MICROSHEATH LP AND LP-AT
- K080922 — SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
- K080969 — HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510
- K081403 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
- K081506 — HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
- K081714 — FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
- K081718 — EXPRESS CHEST DRAIN
- K081826 — INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
- K081963 — AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
- K072370 — SURGICRAFT SURGICAL MESH SYSTEM
- K080357 — MEDELA INVIA WOUND THERAPY
- K080545 — ACTITRAINER
- K080814 — VOCO PROFLUORID VARNISH
- K081325 — ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
- K081351 — MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
- K081431 — MEG LAPAROSCOPIC ELECTRODES
- K081790 — MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM
- K063841 — NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
- K073159 — TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5
- K073246 — ZENIEVA
- K073616 — FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE
- K080212 — MEDELA THOPAZ, MODEL 200 0288
- K080463 — ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES
- K080512 — REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
- K080841 — COSMIC SYSTEM
- K081070 — INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
- K081111 — LEGION HINGE KNEE SYSTEM
- K081177 — BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM
- K081331 — FIXXSURE CROSS LINK
- K081353 — SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
- K081593 — POWER ASPIRATOR, MODEL LS2 OR LS2DP
- K073057 — PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040
- K081157 — ACCUFRAME
- K081171 — TRITANIUM ACETABULAR SHELL SYSTEM
- K081184 — GORE VIABIL BILILARY ENDOPROSTHESIS
- K081227 — PLEXUR M
- K081323 — BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
- K081407 — ORTHOPEDIATRICS PEDIPLATES SYSTEM
- K081677 — SAVI APPLICATOR KIT
- K081776 — CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
- K081916 — GE SIGNA MR ONCOLOGY PACKAGE
- K063662 — RAMP NT-PROBNP ASSAY
- K073030 — AG-605 BLOOD GLUCOSE MONITORING SYSTEM
- K080252 — MODIFICATION TO MAMMAPRINT
- K080341 — ENDODRAPE(TM)
- K080862 — SONICWELD RX (RESORB-X)
- K080864 — CAM STRUCTSURE PRECISION MILLED BARS
- K081218 — BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST
- K081229 — SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING
- K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
- K081515 — NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
- K081655 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW)
- K072334 — SIALO DRAIN
- K080067 — ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
- K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
- K080465 — WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES
- K080583 — MODIFIED HD GUIDE CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.