FDA 510(k) clearances — page 637
clearances on record, most recent first.
Clearances — page 637
63,601–63,700 of 176,637- K060231 — CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
- K060443 — NORIAN CRS FAST SET PUTTY
- K060445 — NORIAN CRS BONE CEMENT
- K060570 — HEMOGLOBIN ALC CONTROL
- K060688 — HEMOSIL SYNTHASIL
- K060748 — MODIFICATION TO XIA 4.5 SPINAL SYSTEM
- K060777 — SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
- K060878 — GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
- K060921 — S2 RECON NAIL SYSTEM
- K052243 — PROACT WITH GEL OR PROACT 1
- K052527 — NEUROPROBES
- K052641 — MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT
- K053459 — OMNILINK .035 BILIARY STENT SYSTEM
- K060039 — INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
- K060119 — MCKINLEY SATURATION CATHETER
- K060217 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML
- K060223 — INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
- K060225 — NUVASIVE SPHERX SYSTEM
- K060327 — VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER
- K060444 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML
- K060470 — ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080
- K060618 — CIDEX ACTIVATED DIALDEHYDE SOLUTION
- K060729 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV
- K060782 — VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE
- K060798 — STRYKER PLATING SYSTEM
- K060959 — SYMMETRY BALLOON DILATATION CATHETER
- K060960 — BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
- K052643 — EPICERAM
- K053520 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
- K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
- K060522 — SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
- K060532 — HDR 1000 PLUS WELL CHAMBER, MODEL 90008
- K060626 — VUMAX
- K060680 — ATRILAZE SURGICAL ABLATION SYSTEM
- K060695 — IBA PROTON THERAPY SYSTEM - PROTEUS 235
- K060697 — TRAVEL PAL (MM-111B) /MEGA MOTION
- K050826 — FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
- K051984 — FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300
- K052322 — BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105
- K053117 — EZ-OX PLUS
- K053441 — BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
- K053542 — SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
- K060064 — STETHOFLUX
- K060193 — MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
- K060260 — MICROPOWER HAND PIECE HIGH SPEED DRILL
- K060270 — MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
- K060282 — TOTAL KNEE SURGETICS NAVIGATION SYSTEM
- K060391 — INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
- K060410 — ECHOHEART TRANSVAGINAL DOPPLER PROBE
- K060658 — BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)
- K060755 — ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
- K060823 — ARTHROCARE WANDS
- K060837 — IN-OVATION C
- K051227 — RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
- K051798 — OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM
- K053563 — HUMAPEN MEMOIR
- K053628 — LIGHTSHEER DUET LASER SYSTEM
- K060105 — VPAP III ST-A/KIDSTA MASK SYSTEM
- K060114 — VECTRA LASER SYSTEM
- K060245 — HARMONIC SCALPEL BLADES AND SHEARS
- K060315 — HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
- K060330 — SEE-IT CARIES DETECTOR
- K060366 — THE AMO OPHTHALMIC SURGICAL SYSTEM
- K060492 — AESCULAP CRANIOFACIAL PLATE AND SCREW
- K060507 — VALPLAST YAMAHACHI TEETH
- K060629 — GELPORT BLUNT TIP TROCAR SYSTEM
- K060661 — MACTRODE 3
- K060797 — NAKED
- K060800 — SEEKER/SPARK ULTRASOUND SYSTEM
- K060802 — VISUM LED SURGICAL LIGHTING SYSTEM
- K060840 — SVIEW
- K050988 — OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
- K050989 — AWQ-104
- K051927 — TECHLAB ASCA-CHEK
- K052420 — G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
- K053413 — TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
- K060044 — ACUTE CARE FACE MASK, MODEL RT040
- K060309 — AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
- K060314 — ROTATING GAMMA SYSTEM. GAMMA ART-6000
- K060385 — EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
- K060548 — STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
- K060628 — DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
- K060638 — DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS
- K060650 — VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702
- K060714 — HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
- K060780 — TONOMETER DIATON
- K052564 — VYGON LEADER-FLEX
- K053121 — TRAM MODULE
- K053407 — OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
- K053478 — ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K060326 — LASERTX - DIODE LASER & DELIVERY SYSTEM
- K060357 — TREK S NEBULIZER COMPRESSOR
- K060566 — MINXRAY, MODELS HFP24 AND HFP40
- K060617 — PTS PANELS HDL CHOLESTEROL TEST STRIPS
- K060741 — SWIRLGRAFT VASCULAR ACCESS GRAFT
- K060779 — ADVANCE VESSEL ANALYSIS II
- K050913 — DICK'S FORMALWEAR MALE LATEX CONDOM
- K051438 — VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
- K052319 — IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
- K053388 — MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
Data sourced from openFDA. This site is unofficial and independent of the FDA.