FDA 510(k) clearances — page 609
clearances on record, most recent first.
Clearances — page 609
60,801–60,900 of 176,637- K063399 — ALEUTIAN SPACER SYSTEM
- K063569 — EQUINOXE REVERSE SHOULDER SYSTEM
- K063608 — DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
- K063754 — DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
- K063777 — ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
- K070042 — POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW
- K070107 — PARI HYDRATE G
- K070149 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K070197 — ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
- K070199 — RETIC-CHEX LINEARITY FOR BC
- K070260 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
- K070268 — SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X
- K070280 — CARDIODAY, VERSION 2.0
- K070301 — HEMOSIL ANTITHROMBIN
- K062388 — ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
- K062432 — NANOTITE DENTAL IMPLANTS
- K062444 — HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT
- K063488 — MAXO2 CU
- K063531 — SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM
- K063540 — BIPAP AUTOSV
- K063596 — PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
- K063639 — AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1
- K063713 — AMS SMART SLING SYSTEM
- K070076 — POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K070266 — 560 HIGH DEFINITION CAMERA SYSTEM
- K062952 — C300 SERIES AIR NEBULIZER COMPRESSOR
- K070189 — ACCU-CHEK ULTRAFLEX INFUSION SET
- K070236 — SBI LATERAL RADIO CAPITELLUM
- K062527 — BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
- K062565 — STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
- K062756 — PATHIAM IMAGING SOFTWARE FOR HER2/NEU
- K063533 — BIPAP SYNCHRONY
- K063614 — ALTRA FX HIP SYSTEM
- K063704 — BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
- K070037 — POWDER FREE VINYL PATIENT EXAMINATION GLOVE
- K070102 — SOPRO 162 CAMERA
- K061379 — INFINITY TELESMART TELEMETRY SYSTEM
- K062437 — DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
- K062445 — MONITORING EAR THERMOMETER, MODEL BTM-D1A
- K062464 — MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR
- K062567 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
- K062689 — SIDESTREAM PLUS
- K063236 — BETA-POWDER
- K063349 — CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
- K063517 — HEALADEX-P
- K063520 — ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
- K063523 — ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16
- K070030 — POWDER FREE VINYL PATIENT EXAMINATION GLOVE
- K070088 — ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM
- K070246 — DOWN PAK
- K061467 — EXSEPT WC WOUND CLEANSER
- K062603 — BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230
- K062946 — TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
- K063183 — PRISMA M10 PRE SET
- K063404 — SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800
- K063425 — DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
- K063650 — VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
- K063655 — DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH
- K070128 — CO2 EASY
- K070131 — RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS
- K070150 — VASCUPUNCTURE PICC GUIDEWIRE
- K070161 — QUATTRO CATHETER MODEL IC4593
- K070323 — TEMPORARY LIMB SALVAGE SHUNT
- K061897 — EXCEL CONTRA ANGLE HANDPIECE
- K062069 — ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT
- K062546 — IMMUNOCARD STAT! EHEC, MODEL 751630
- K062569 — SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
- K063544 — MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
- K063697 — SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT
- K063824 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML
- K070101 — UNIBLATE ELECTROSURGICAL DEVICE
- K052836 — BODIHEALTH SYSTEM
- K062200 — COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS
- K062739 — CINCH BONE ANCHOR SYSTEM
- K063118 — BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
- K063203 — ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)
- K063860 — THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
- K070187 — POWDER FREE VINYL PATIENT EXAMINATION GLOVE
- K061252 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
- K062953 — MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
- K063441 — 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
- K063549 — NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
- K070287 — PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
- K062012 — S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
- K062532 — ELECTROPULSE - LOW BACK PAIN
- K063026 — OK METER BLOOD GLUCOSE MONITORING SYSTEM
- K063114 — DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
- K063386 — LORENZ ORTHODONTIC ANCHORAGE SYSTEM
- K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
- K063571 — PALOMAR LUX2940 HANDPIECE
- K063595 — CLEARFIL MAJESTY POSTERIOR
- K063682 — INTRALASE FUSION LASER
- K063778 — FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
- K063811 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML
- K070075 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K070094 — TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM
- K070244 — AEGIS
- DEN060003 — TEPHAFLEX ABSORBABLE SUTURE
- K061131 — DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
- K061309 — EMBRYOASSIST
Data sourced from openFDA. This site is unofficial and independent of the FDA.