FDA 510(k) clearances — page 570
clearances on record, most recent first.
Clearances — page 570
56,901–57,000 of 175,825- K073185 — APX21
- K073277 — ROCHE-CREACTIVE PROTEIN (LATEX)
- K073470 — AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
- K080155 — MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
- K080171 — SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
- K070965 — ALICIA MENSTRUAL CUP
- K071244 — MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
- K071779 — ABX PENTRA URINE CAL
- K072944 — QUANTA LITE CCP3.1 IGG/IGA ELISA
- K073118 — PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
- K073164 — IVS TUNNELLER DEVICES
- K073276 — IONTOPHORESIS SYSTEM
- K073279 — VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM
- K073299 — BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
- K073474 — CAPIOX CIRCUIT CONNECTORS
- K073507 — ANCHORAGE ACCESS KIT
- K073544 — PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES
- K073552 — LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
- K073553 — CAMLOG IMPLANT SYSTEM ABUTMENTS
- K073589 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS
- K073659 — XTRAC ULTRA 2, MODEL AL10000
- K080066 — VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR)
- K080193 — SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR
- K080322 — HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
- K080340 — COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG
- K080471 — RADIO BIOAQUACARE
- K070355 — FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY
- K072793 — LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688
- K073156 — QPLAQUE MR
- K073509 — TWINFIX PK FP SUTURE ANCHOR
- K073627 — FLEXOR EVAC ASPIRATION CATHETER
- K080494 — BAXANO ULTRA LOW PROFILE RONGEUR
- K072459 — OMNILUX NEW-U
- K072816 — NIOX MINO
- K073119 — CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
- K073339 — BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
- K073405 — PLEXUR M
- K073485 — VISTAKON (NARAFILCON) A SOFT CONTACT LENS
- K073647 — MINITAPE EXTRA URETHRAL SLING
- K080035 — LED CURING LIGHT
- K072274 — MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
- K072683 — AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
- K072802 — SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
- K073061 — THE PROXIVENT KIT
- K073091 — VIDAS NT-PROBNP ASSAY, MODEL: 30 449
- K073120 — ACCIN PATELLOFEMORAL SYSTEM
- K073228 — DC ULNAR SHORTENING SYSTEM
- K073380 — SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI
- K073402 — SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM
- K073418 — SYNGO IMAGING CCF VA10A
- K073540 — ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT
- K073688 — EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
- K080176 — ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
- K080229 — 5.5 MM SUTURE LOCK BONE SCREW ANCHOR
- K080421 — HEART SYNC, MODELS C-100 AND T-100
- K071343 — ELLMAN NOBLE ALLOY ELECTRODES
- K072054 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310
- K072211 — INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS
- K073027 — SPECTRA MRSA
- K073048 — PETERIO UNIVERSAL LASER SCANNING HANDPIECE
- K073116 — EBI INTERNAL IMPLANT SYSTEM
- K073163 — LIMITED ARTIFACT SKULL PIN, MODEL 0107
- K073191 — ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
- K073329 — SYGNAL DBM
- K073355 — CALCIUM, SCAL, NORTROL, ABTROL
- K073384 — SMART COUPLER, MODEL M015401
- K073407 — PACIFICA
- K073459 — CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
- K073549 — Q-PLUS T
- K073557 — EEG NEUROAMP, MODEL CS10137
- K080006 — AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
- K080032 — ENVOYCEM, MODEL 1640
- K080068 — BEAUTIFIL OPAQUER
- K080107 — VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
- K080145 — PRIMAEVA MEDICAL SYSTEM
- K080219 — MODIFICATION TO:NESS L300
- K071839 — SOCT COPERNICUS, MODEL 15205
- K073063 — 15W CERALAS D 1470NM DIODE LASER
- K073150 — APEX-LNK POLY ACETABULAR CUP LINERS
- K073266 — WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
- K073369 — EI DOWNPAK BARRIER SLEEVES
- K073528 — VENA CAVA FILTER
- K073620 — GUARDIAN HEMOSTASIS VALVE
- K073686 — C.T.M. POWER CHAIR, MODEL HS-1500
- K080147 — ELECSYS PROBNP II CALCHECK
- K080242 — HEARTWAY POWER MOBILITY SCOOTER, PF7
- K080247 — QUIKCLOT NOSEBLEED
- K080295 — CHARLOTTE CLAW 3.5
- K072055 — LAVA FRAME, LAVA FRAME SHADE
- K072145 — MEDICAL GLOVE SERIES
- K072812 — PHILIPS HEARTSTART SMARTPADS III
- K073138 — CARDIQ EXPRESS VERSION 2.0
- K073153 — CARDIQ FUNCTION XPRESS
- K073338 — CELLSEARCH CIRCULATING TUMOR CELL KIT
- K073442 — MICRUS MICROCOIL SYSTEMS
- K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
- K080144 — MANDREL GUIDEWIRES OR M-WIRES
- K080206 — MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
- K080253 — KIMBERLY-CLARK INTRODUCER KITS
- K080289 — 1500 PRO
Data sourced from openFDA. This site is unofficial and independent of the FDA.