FDA 510(k) clearances — page 1424
clearances on record, most recent first.
Clearances — page 1424
142,301–142,400 of 175,890- K863859 — TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM
- K863860 — TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN
- K863861 — TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
- K864084 — LYOFOAM C ODOR-ABSORBING DRESSING
- K864399 — FISHER PRICE SUNJAMMERS
- K860858 — OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
- K861179 — CANDELA MODEL SPT-1, PULSED DYE LASER
- K862316 — CASE 12
- K863030 — 630C ELECTROCARDIOGRAPH
- K863138 — TERUMO RADIFOCUS GUIDE WIRE
- K863427 — CLAMPEASE FA
- K863596 — CHIN-FOGARTY INFLATION DEVICE
- K863724 — MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
- K863845 — EM III DISPOSABLE ELECTRODE
- K864002 — MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD
- K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
- K864163 — HALL DUNBAR DRILL GUIDE SYSTEM
- K864287 — MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD
- K861699 — CATHETER VALVES KV 100 & KV 100EH
- K862598 — LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM
- K862727 — ZINETICS GASTROMETER (TM)
- K862877 — MALE URINARY STRESS PAD*
- K862878 — FREE & ACTIVE(TM) ABSORBENT PADS
- K863565 — MENTOR ALLOPLASTIC SPERMATOCELE
- K863854 — P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG
- K863896 — AUSTIN MOORE HIP PROSTHESIS
- K864059 — DENTAL PROPHY CUPS (VARIOUS TYPES)
- K864106 — SR-MODEL 230 (MODIFICATION)
- K864195 — SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T
- K864295 — DR.500O OPERATING TABLE
- K864314 — EFTEKHAR RECHANNELIZATION DRILL GUIDE
- K864325 — DR7700 OPERATING TABLE
- K864338 — SECONDARY SET LOCK
- K864380 — LUTEX HEADLIGHT SYSTEMS
- K864384 — LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS
- K860801 — MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
- K862200 — FORTEC MI-100, BLOOD PRESSURE METER
- K863124 — MODEL 8 EEG PREAMPLIFIER
- K863515 — MODIFIED SARNS OXYGENATOR SYSTEM
- K863541 — STOCKERT-SHILEY CAPS HLM INTERFACE
- K863593 — SARNS SAFETY LOOP
- K863672 — MODEL (MB-700) BLOOD PRESSURE MONITOR
- K863882 — OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE
- K863979 — MICROSCREEN I HEARING TESTER
- K863984 — MODEL 320 TWO CHANNEL AUDIOMETER
- K863987 — BI-TEMP TEMPERATURE MONITOR
- K864096 — DREAM DAM
- K864215 — PROPHY CARE SOLUTION
- K864307 — MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)
- K854279 — NORELCO ELECTRONIC DIGITAL BP METER HC3030
- K855048 — NORELCO DIGITAL BLOOD PRESSURE METER HC3001
- K861023 — DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER
- K862714 — BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM)
- K862720 — VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES
- K862815 — LASER SURGICAL ROD
- K863389 — UNITED WOUND COVERING, PACKAGE OF 5
- K864160 — LEUKOPLAST(R) POROUS AND SPORT TAPE
- K864165 — MBK SURGEONS'(STERILE & NON-STERILE) SURG GLOVES
- K864193 — GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN
- K864371 — SURGICAL SKIN MARKER
- K864386 — LUXTEC LOUPES FOR SURGICAL VISION
- K862448 — FLOW GENERATOR FOR SLEEP APNEA, LDS 1500
- K862803 — CHESEBROUGH POND'S HYDROCOLLOID DRESSING
- K863865 — TENSOTAPE SURGICAL ADHESIVE TAPE
- K864013 — MODEL Q55XT POWERED TREADMILL
- K864108 — PUSH CUSH
- K864109 — C' AIRECUSH SEAT CUSHION
- K864204 — VOCAID, ELECTRONIC VOCAL AID
- K852767 — ERYTHOCYTE CREATINE
- K853827 — LIFE-PORT IMPLANTABLE VASCULAR ACCESS
- K862412 — INTESTOPLANT
- K862418 — BENZODIAZEPINES TOXICOLOGY CONTROL
- K862419 — SERUM VANCOMYCIN TOXICOLOGY CONTROL
- K862799 — SKIN PURE
- K863158 — MODEL T-1 OXYGEN ANALYZER
- K863300 — Q101 DIAGNOSTIC SPIROMETER
- K863363 — CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY
- K863401 — RECOVER
- K863670 — VISION (TM) CALCIUM
- K863719 — AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1
- K863741 — IMMUNO-CEPT D (BETA-MONOCLONAL)
- K863756 — MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT
- K863874 — LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES
- K863926 — GLUCOSE OXIDASE
- K863929 — TERUMO SENSIBEAD(TM) EIA HLH KIT
- K863948 — A-GENT(TM) LIQUID GLUCOSE TRINDER
- K863956 — MACULOSCOPE(TM)
- K863995 — KEYNOTE
- K864028 — MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID
- K864029 — AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID
- K864030 — MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID
- K864031 — MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID
- K864033 — RAPID ACID FAST STAIN
- K864037 — KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER
- K864063 — ORION 3001, LASER PHOTOCOAGULATOR
- K864069 — PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID
- K864071 — FAULKNER FORCEPS
- K864080 — UBI MAGIWEL(TM) FSH QUANTITATIVE
- K864127 — MECHANICAL OXYGEN REGULATOR
- K864157 — OPTI-BRUSH
Data sourced from openFDA. This site is unofficial and independent of the FDA.