FDA 510(k) clearances — page 536
clearances on record, most recent first.
Clearances — page 536
53,501–53,600 of 175,825- K083841 — ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL
- K083848 — ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM
- K090297 — BLUESHINE GOLD SERIES
- K090460 — BONOS INJECT
- K090618 — CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
- K083534 — LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
- K083672 — P.D SOFTWARE
- K090148 — PROGUIDE CHRONIC DIALYSIS CATHETER
- K090244 — SWIFT FX
- K080561 — VIDAS CA 125 II ASSAY
- K082065 — WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
- K082759 — ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
- K083191 — DETLOGIX ANNULOPLASTY RING, MODEL: 5100
- K083349 — BLOOD TRANSFUSION SET
- K083519 — AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
- K090186 — CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
- K090189 — ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
- K090350 — EXTREME 4X4-X8 POWER WHEELCHAIR
- K090357 — HYDROFRAME (HES)
- K090873 — I OPEN 0.5T
- K082309 — CAMBRIA
- K083012 — PAPCONE
- K083705 — BCI WW1020 PULSE OXIMETER, MODEL WW1020
- K083861 — TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
- K090014 — CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE
- K090043 — AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
- K090064 — EMINENT SPINE INTERBODY FUSION SYSTEM
- K090065 — AEROCHAMBER MINI VENTILATION CHAMBER
- K090663 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K082251 — SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
- K082951 — IMMERSION HYDROBATH
- K083007 — PROWICK
- K083215 — INCISIVE FAMILY OF INPULSE ND:YAG LASERS
- K083278 — AVC A/H5N1 FLU TEST
- K083284 — PIEZOSURGERY MEDICAL
- K083483 — BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
- K090057 — ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K090253 — ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
- K090465 — DIGDOP ULTRASOUND SYSTEM
- K090620 — QUIKCLOT INTEVENTIONAL, MODEL P/N 182
- K090801 — ELECTRONIC HOUSE CALL
- K080243 — PORTABLE OXYGEN UNIT SCA900
- K082130 — EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
- K082634 — VERTIGONE BPPV GOGGLE
- K082679 — LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
- K083116 — VERSAFIT CUP DOUBLE MOBILITY SYSTEM
- K083581 — LANX SPINAL FIXATION SYSTEM
- K083627 — WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
- K083809 — CREATININE
- K090087 — MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
- K090316 — MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
- K090411 — FREEDOM METAL BACKED TIBIAL COMPONENT
- K090723 — HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,
- K090853 — YIELD TISSUE SAMPLER
- K082806 — SPINNING SPIROS, MODEL CH-2000
- K090318 — CARESTREAM DRX-1 SYSTEM
- K081166 — LIGHTSTREAM LOW LEVEL LASER
- K082327 — INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
- K082470 — SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
- K082846 — APK SPO2 PULSE OXIMETER SENSOR
- K083466 — MD2000A VITAL SIGN MONITOR, MODEL MD2000A
- K083539 — INFANT CARDIAC ARRAY
- K083779 — MAK OSS KNEE FEMORAL COMPONENTS
- K083782 — REGENEREX PATELLA COMPONENTS
- K090140 — GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
- K090249 — MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM
- K090292 — PREMISE MODIFIED
- K090327 — POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE
- K090352 — TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
- K090398 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY
- K090669 — RIGIDFIX BIOCRYL CROSS PIN KITS
- K090743 — YIELD MINI DOPPLER SYSTEM
- K090805 — V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
- K090808 — PINNACLE3 SMARTARC
- K090878 — MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)
- K080950 — STIWELL MED4
- K081770 — BLACK WIDOW ANTERIOR BUTTRESS PLATE
- K082333 — ASAP WOUND DRESSING GEL
- K082782 — REPLICATION MEDICAL VESSEL GUARD
- K082793 — INTERGRO DBM
- K083386 — ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
- K083482 — COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
- K083622 — LNCS OXIMETRY SENSORS
- K083693 — PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
- K090003 — ZETAJET
- K090130 — ATMOS S041 WOUND
- K090585 — NEOSALUS CREAM
- K090624 — COOK MREYE EMBOLIZATION COILS
- K090713 — ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
- K081527 — LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
- K082080 — ALCO TUBE PLUS
- K082796 — SOPRO 184 CAMERA
- K083098 — NAVIGATOR APPLICATIONS SUITE
- K083310 — SPINE & TRAUMA ICT
- K083393 — XIA 3 SPINAL SYSTEM
- K083524 — SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
- K083569 — SURGYBONE
- K083674 — PK-141 PATIENT CABLE
- K083820 — VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C
- K090047 — SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.