FDA 510(k) clearances — page 765
clearances on record, most recent first.
Clearances — page 765
76,401–76,500 of 175,825- K013210 — TRUWAVE
- K013369 — RESECTION ABLATOR
- K013428 — MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
- K013569 — ORTHOPILOT 2
- K013988 — MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
- K020058 — MEDICAL LE
- K020067 — GYRUS ENT SOMNOPLASTY GENERATOR
- K020154 — VT-1
- K020258 — SUPPORT SLEEVE
- K020323 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
- K020469 — CAL-CHEX CD PLUS
- K020773 — LONG LENGTH GAMMA NAIL
- K020789 — GE VIVID 3 EXPERT; GE VIVID 3 PRO
- K020933 — GARAVENTA SUPER-TRAC TRE-52
- K020946 — ADPER PROMPT
- K020949 — APOLLO, MODEL 1124525
- K020970 — MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
- K020988 — PAIN CARE 4200
- K020997 — APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
- K020998 — SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
- K011986 — SAFE-STEER GUIDE WIRE SYSTEM
- K012221 — SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
- K013106 — 2 PIECE MODULAR HIP STEM
- K013204 — AQUIFY LENS COMFORT DROPS
- K013762 — RIGID GAS PERMEABLE CONTACT LENS
- K020024 — CARIS MINITOME BIOPSY INSTRUMENT
- K020059 — MFCD 118I
- K020061 — IMAGEDESK
- K020110 — MODIFICATION TO TRELEX MESH SURGICAL MESH
- K020147 — MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
- K020308 — REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE
- K020371 — UPLINK TEST SYSTEM
- K020455 — TISSUEMEND SOFT TISSUE REPAIR MATRIX
- K020592 — ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
- K020674 — BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
- K020681 — EBI OMEGA21 SPINAL FIXATION SYSTEM
- K020688 — HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR
- K020761 — POWER TEK II
- K020767 — ADVANTA SST BIFURCATED GRAFT
- K020769 — SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
- K020913 — CT-C3000 SPIRAL CT SCANNER SYSTEM
- K020929 — SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5
- K020935 — HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
- K011510 — MULTI HI-FLO PNEU, WISAP #7080
- K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST
- K013169 — IMMUNE CELL FUNCTION ASSAY
- K013363 — CROSSPOINT TRANSACCESS CATHETER
- K020043 — 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B
- K020221 — IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
- K020682 — BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
- K013715 — RE-USABLE STERILIZATION POUCH / BAG
- K020629 — SIMPLICITY SIMPLEX SOFT INFUSION SET
- K013779 — THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F
- K013871 — LIFEGUARD SAFETY INFUSION SET
- K014302 — UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
- K014305 — RESORBABLE LACTOSORB-L ACL CROSSPIN
- K020006 — DYNA INTRA-LIMBAL LENS
- K020267 — OPTILUX CURING LIGHTS
- K020467 — SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
- K020650 — MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
- K020659 — DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
- K020677 — GAMMA 3 LAG SCREW
- K020702 — O'REGAN DISPOSABLE ANOSCOPE
- K020871 — VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
- K020898 — D.SIGN 15 (DW286 B)
- K020973 — EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO
- K011588 — SURETONE
- K012041 — THE HAMMER MODEL H100
- K013551 — ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM
- K013714 — CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP
- K013984 — IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
- K014289 — ORTHOSS RESORBABLE BONE VOID FILLER
- K014290 — ENTEC PLASMA WANDS
- K020342 — UNIFIL FLOW
- K020441 — EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
- K020490 — PBS, PBSW WITH CATIONS AND PHENOL RED
- K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS
- K020622 — ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS
- K020663 — MODIFICATION TO SPARC SLING SYSTEM
- K020667 — CODMAN HAKIM SHUNT SYSTEMS
- K020669 — PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
- K020798 — HEMOCHRON JR. SIGNATURE +
- K011400 — MRSA-SCREEN
- K012520 — GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
- K012849 — GLASS POST
- K012994 — WIZAIR DVT
- K013488 — SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
- K013931 — OMNI OXYGEN SYSTEM, MODEL 1000
- K013949 — UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
- K014260 — TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE
- K014268 — NORAPAD PLAIN; NORAPAD TA
- K014272 — PERIOLASE ND:YAG DENTAL LASER SYSTEM
- K014304 — BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
- K020031 — EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302
- K020269 — PROCERA ALLCERAM BRIDGE MATERIAL
- K020322 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
- K020611 — UNIVERSAL BONE PLATE III SYSTEM (UBP III)
- K020680 — PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
- K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
- K020881 — MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.