FDA 510(k) clearances — page 1431
clearances on record, most recent first.
Clearances — page 1431
143,001–143,100 of 176,637- K864116 — ANAGO ISOLATION MASK (#80-950)
- K864213 — IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY
- K864214 — IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
- K864271 — IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA
- K864372 — OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE
- K864506 — SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1
- K864513 — LP ARTHROSCOPIC THIGH HOLDING DEVICE
- K862478 — HAYES VAGINAL SHIELD
- K862903 — MIDDLE EAR VIEWER AND FLUID COLLECTOR
- K862958 — AMR RESEARCH TONOMETER
- K863056 — BILIRUBIN TOTAL
- K863102 — GLUCOMETER-E
- K863109 — FERROFAST
- K863338 — 7.5 MHZ LINEAR SMALL PARTS PROBE
- K863361 — MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA
- K863558 — URESIL CAROTID SHUNT
- K863583 — CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER
- K863742 — FLEXMEDICS NITINOL ARCH WIRE
- K863751 — MULTI-ANALYTE LIN-TROL
- K863825 — CO-OXIMETER SOLUTIONS
- K863849 — LIQUI-SERA COMBO LIGAND/TDM CONTROLS
- K863880 — BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.
- K863889 — UREA NITROGEN TEST
- K863901 — IQ UREA NITROGEN
- K863915 — SHAPE-ACTIO METAL TOXICOLOGY CONTROL
- K863921 — DAIG TYPE O4 VS-1 CONNECTOR
- K863923 — TRIGLYCERIDES
- K863924 — URIC ACID
- K863925 — UREA NITROGEN(BUN)
- K863927 — CHOLESTEROL
- K864144 — LUTEINIZING HORMONE (LH-IRMA) RIA KIT
- K864156 — PROGESTERONE SYSTEM BY EIA
- K864205 — THERMONUCLEASE AGAR W/TOLUIDINE BLUE
- K864208 — VISION (TM) GGTP
- K864300 — SILIVA EJECTOR/ORAL CAVITY EVACUATOR
- K864334 — ACUSYST-P (CELL CULTURE EQUIPMENT)
- K864340 — WILLIAMS ORTHOPAEDIC SURGICAL INSTRUMENTS
- K864404 — PENTRON HIGH STRENGTH PORCELAIN
- K864422 — RAYLOR(TM) MALLET
- K864423 — RAYLOR(TM) OSTEOTOMES
- K864461 — MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY
- K864505 — SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
- K864011 — EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES
- K863366 — PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE
- K863534 — LIFE-WATCH MONITOR LT-8
- K863784 — NELLCOR N-200 (PULSE OXIMETER)
- K863838 — CREST CERVICAL TRACTION
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.