FDA 510(k) clearances — page 600
clearances on record, most recent first.
Clearances — page 600
59,901–60,000 of 176,637- K062484 — FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
- K062704 — STERILIZATION POUCH WITH INDICATORS
- K070380 — PORTACLAMP FLEX
- K070573 — SYNAPSE SYSTEM
- K070654 — HYPERTHERMIA PUMP
- K070810 — ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
- K071047 — MASIMO PATIENT SAFETY NET
- K071241 — LMS-LIVER
- K071310 — SYNGO CT ONCOLOGY SOFTWARE PACKAGE
- K071360 — OPTICAL GUIDANCE PLATFORM
- K071402 — X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM
- K071409 — X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM
- K061956 — ARTELON STT SPACER
- K062541 — CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
- K062902 — PAJUNKS EPILONG SET PEDIATRIC
- K063008 — HEALTH CHECK KIOSK
- K063685 — OPTECURE; OPTECURE + CCC
- K063692 — V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
- K063740 — V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
- K070320 — EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01
- K070395 — KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K070695 — ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
- K070723 — FUTURABOND DC/SINGLE DOSE
- K070760 — POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
- K070842 — ULCELOOCIN ORAL ULCER PATCH
- K070880 — ER35 ERO-SCAN PRO HEARING TEST SYSTEM
- K070926 — ELECTRODE/EXTENSION CABLES, MODELS ATAR
- K071109 — SACS EEG WORKSTATION A7
- K071140 — MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
- K070756 — SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
- K070946 — SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES
- K071141 — BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
- K071142 — GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
- K071143 — BD TRITEST CD3/CD4/CD45, MODEL 340383
- K060434 — ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
- K070417 — ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
- K070633 — GENIE, MODEL CH-200
- K070878 — DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300
- K071158 — AURALAY PIT & FISSURE SEALANT
- K071249 — ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
- K071386 — AMARIS/AMARIS FLOW
- K071462 — UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
- K062112 — SUNMED FOLEY CATHETERS
- K070566 — INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
- K070835 — OLYMPUS CK-MB REAGENT
- K070951 — 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
- K061954 — ARTELON CMC SPACER ARTHRO
- K062636 — OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS
- K063699 — IMDX SYSTEMS
- K070095 — TRIATHLON TS KNEE SYSTEM
- K070372 — GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610
- K070864 — BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER
- K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
- K070991 — VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310
- K071086 — RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0
- K071220 — COLUMBUS TOTAL KNEE SYSTEM AS
- K071237 — COPIOS BONE VOID FILLER SPONGE AND PASTE
- K071246 — MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR
- K071277 — SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
- K071280 — SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
- K071283 — SYNCHRON SYSTEMS CREATININE REAGENT
- K071358 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
- K062149 — SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES
- K070074 — LUBRINA, MODEL HIM-1
- K070716 — IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
- K071206 — ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
- K061385 — OSSTAPLE, OSSPLATE, OSSFORCE
- K062979 — THYROSAMPLER
- K063042 — CARDIOMEM CM 3000-12BT
- K070382 — VISTA -S DEVICE
- K070638 — THEKEN ATOLL CERVICO-THORACIC SYSTEM
- K070651 — ARAGON SURGICAL LAPCAP
- K070692 — DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
- K070793 — SBI DISTAL RADIUS VOLAR PLATING SYSTEM
- K070814 — MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP
- K070862 — POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE)
- K071181 — DIRECT DIGITIZER, REGIUS MODEL 110
- K071185 — MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
- K071193 — VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
- K071235 — ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13
- K071362 — VITAL CONNECT 4.1
- K062025 — ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
- K062823 — AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES
- K070264 — 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
- K070416 — NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
- K070575 — EVICEL APPLICATION DEVICE
- K071338 — FLEX ARM RETRACTOR SYSTEM
- K061943 — ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM
- K062171 — EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES
- K063661 — RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20
- K063868 — MASSTRAK IMMUNOSUPPRESSANTS KIT
- K070014 — AUTO DETECT FOR TELAHEART DR200/E-A
- K070070 — ASCENT DENTAL CLEANSER
- K070239 — MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
- K070327 — REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
- K070408 — DURAMAX REUSABLE OXIMETRY SENSOR
- K070547 — SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
- K070561 — KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
- K070568 — DIO PROTEM IMPLANT SYSTEM
- K070585 — ACCU-CHEK PERFORMA SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.