FDA 510(k) clearances — page 830
clearances on record, most recent first.
Clearances — page 830
82,901–83,000 of 176,637- K002353 — ELECSYS CA 15-3 CALCHECK
- K002364 — PROTEMP H
- K994231 — SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)
- K000574 — IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
- K001162 — GOLDFINGER DEVICE
- K001414 — KWIKKMODEL
- K001492 — QUINTON Q-STRESS, MODEL 000483
- K001727 — MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
- K001764 — HOTLINE 2 FLUID WARMER
- K001887 — MODIFICATION TO PASCO MIC AND MIC/ID PANELS
- K002012 — SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K002015 — SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K002116 — S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
- K002118 — STOCKERT COMPACT SYSTEM VERSION 2.0
- K002221 — KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
- K993913 — TRUE
- K000388 — CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
- K000736 — LA JOIE
- K001404 — GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON
- K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
- K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
- K002225 — OR TABLE/MAGNETOM OPEN VIVA SYSTEM
- K002239 — SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM
- K002258 — ULTRAGUIDE CT-GUIDE 1010
- K001126 — PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
- K001456 — CONSENSUS KNEE SYSTEM
- K001471 — THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
- K001547 — ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
- K001761 — STATLYTE NA/K/CL/LI ANALYZER
- K001767 — DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
- K002134 — ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
- K002196 — LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
- K984390 — LACTOSORB PANELS AND FASTENERS
- K994395 — INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
- K000084 — ENRAF-NONIUS SONOPULS 190 SYSTEM
- K000568 — HDL CHOLESTEROL PLUS
- K000593 — SONIC, MODEL SO-100
- K000653 — AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
- K000788 — APEX MODULAR HIP STEM
- K001009 — RANDOX C-REACTIVE PROTEIN
- K001448 — TRIDENT ACETABULAR SHELLS: PS-HA
- K001449 — TRIDENT ACETABULAR SHELLS: PS
- K001470 — E-Z LINK CROSS CONNECTOR
- K001476 — TORQUE INSTRUMENT, MODEL 8500
- K001571 — BAUMER FEMORAL HEAD
- K001614 — STRYKER TRAUMA PELVIC SET
- K001645 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
- K001721 — PASCO MIC AND MIC/ID PANELS
- K001724 — STIMULAN -CALCIUM SULFATE BONE VOID FILTER
- K001803 — ACCELERATOR RECIPROCATING CANNULA
- K001808 — DORO HEADREST SYSTEM
- K001913 — CLEARFIL ST OPAQUER
- K001975 — CERALAS D10 810NM LASER, MODEL CERALAS D10-60
- K001994 — EEI SLUSH PAN DRAPE
- K002107 — IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
- K002170 — MODEL 9000 PEDIATRIC WHEELCHAIR
- K983299 — ALLEGIANCE GENESIS CONTAINER SYSTEM
- K991522 — MICROTARGETING ELECTRODE
- K991971 — ARTHREX CHONDRAL DART, MODEL AR-4005B-18
- K992133 — NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
- K992226 — XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
- K993166 — STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
- K993788 — R.TEST EVOLUTION
- K994399 — INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
- K994400 — INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
- K001553 — BREAS PV 100 CPAP SYSTEM
- K001641 — TAMPONS
- K001878 — WATER PURIFIER
- K002053 — NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
- K002212 — MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
- K993052 — VYGON 2 FR EPICUTANEO PUR-CATHETER
- K993442 — VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)
- K994109 — DETRUSAN 500
- K994155 — EXCELSIOR 1018 MICROCATHETER
- K001077 — LUBRIGEL PERSONAL LUBRICANT
- K001409 — GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
- K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
- K001590 — DND 101
- K001662 — CHASE CARDIOVASCULAR PATCH
- K001736 — GALEO HYDRO AND GALEO HYDRO J-TIP
- K001825 — STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER
- K001928 — SIGMA
- K002009 — HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
- K990100 — POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
- K993140 — WATER FOR TISSUE CULTURE, MODELS 1500
- K000204 — WIN-1 TANGO
- K000737 — COAXIAL DILATOR SET
- K001182 — MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1
- K001400 — ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM
- K001410 — PHORESOR MODEL PM2000
- K001467 — DA VINCHI EMG/EP ISA1004EP
- K001496 — A.V. FISTULA NEEDLE
- K002085 — ULTRASOUND SCANNER, TYPE 1101
- K002185 — SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
- K990517 — EXPLORER CVS TRANSCRANIAL DOPPLER
- K992905 — CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
- K993524 — ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS
- K001515 — PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
- K001533 — SURGIFLATOR-40
- K001539 — RENU MULTIPLUS MULTI-PURPOSE SOLUTION
Data sourced from openFDA. This site is unofficial and independent of the FDA.