FDA 510(k) clearances — page 497
clearances on record, most recent first.
Clearances — page 497
49,601–49,700 of 176,542- K102108 — CLICKFINE PEN NEEDLE
- K102202 — GS 3000
- K102207 — FIBER FORCE
- K102237 — PVS MODEL 1.0
- K102254 — DMP SINGLE BONDING
- K102255 — DMP ETCHING GEL
- K102339 — CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
- K102343 — EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM
- K102429 — ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
- K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
- K102802 — INTEGRA ELECTRODE TUNNELING NEEDLE
- K102849 — ACCULMAING
- K102904 — ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
- K103202 — PREASSEMBLED SURGICAL WASH SET
- K103268 — OMNI EXPRESS
- K103269 — PATCHASSIST LARGE
- K093055 — CSTS SCREW
- K101547 — HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)
- K101755 — AIDI DENTAL IMPLANT SYSTEM
- K101817 — LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N
- K102114 — MEDRANGE ELECTROSURGICAL GENERATOR
- K102122 — SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
- K102217 — SYSTEM 1E CHEMICAL INDICATOR
- K102308 — SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS
- K102444 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K102519 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
- K102620 — POWDERFREE BLACK NITRILE EXAMINATION GLOVES
- K103104 — SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
- K103263 — ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY
- K092728 — 20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)
- K092745 — VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU
- K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
- K094016 — NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H
- K100185 — SLEEP APP
- K100598 — PENRITH ELETTRA ULTRASOUND SYSTEM
- K101822 — NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K101940 — EQUASHIELD SYSTEM PROTECTIVE PLUS
- K102010 — VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET
- K102015 — OSTEON, OSTEON SINUS, OSTEON LIFTING
- K102147 — CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
- K102257 — NANOCERAM- BRIGHT
- K102390 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
- K102612 — VOCO IONOFIL MOLAR AC QUICK
- K102855 — UNIVERSAL IRRIGATION SOLUTION HYBRID
- K102880 — BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)
- K102923 — BARRIER N95 PARTICULATE RESPIRATOR
- K103057 — ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
- K103090 — SPECTRA OPTIA R APHERESIS SYSTEM
- K103118 — REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
- K103124 — SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
- K092272 — RANDOX METHADONE ASSAY
- K093891 — AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
- K100450 — I-ROOT
- K100607 — COULTER 4C-EX 300 CELL CONTROL
- K100720 — K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING
- K101031 — MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
- K101133 — SENSOMETRICS SOFTWARE
- K101244 — SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
- K101368 — D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES
- K102043 — ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
- K102083 — VELSCOPE VX
- K102112 — CRITICOOL PRO
- K102146 — BAHADIR STERILIZATION TRAYS
- K102236 — HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P
- K102365 — MICROPLEX COIL SYSTEM- COSMOS
- K102377 — VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O
- K102433 — MOORVMS-PRES PRESSURE CUFF CONTROLLER
- K102615 — WIRELESS DR IMAGING OPTION-WDR1
- K103162 — ELECSYS PTH CALCHECK 5
- K093071 — FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
- K093758 — BGM GALECTIN -3
- K101436 — PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
- K102097 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K102159 — POWERPICC SV CATHETERS
- K102531 — MUCOGRAFT
- K102546 — CHITOGAUZE
- K102555 — CD HORIZON SPINAL SYSTEM
- K102603 — SA FLOWABLE ADHESIVE
- K102650 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K102657 — CONCENTRIC BALLOON GUIDE CATHETER
- K102668 — ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
- K102669 — DIODE LASER THERAPY SYSTEM
- K102807 — CD HORIZON SPINAL SYSTEM
- K103100 — MOUNTAINEER OCT SPINAL SYSTEM
- K100565 — DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
- K102068 — MINIATURIZE CHEST COMPRESSOR (MCC)
- K102171 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K102540 — PTFE PORTABLE INTRODUCER
- K103282 — LAPAROSCOPIC DISSECTOR
- K093054 — SCALP DURA RETRACTOR, MODEL KS00474
- K100888 — MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
- K101762 — VIPER F2 FACET FIXATION SYSTEM
- K102204 — CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM
- K102326 — PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR
- K103215 — CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT
- K101174 — ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
- K101285 — CONSTELLATION VISION SYSTEM
- K101619 — WELCH ALLYN 1500 PATIENT MONITOR
- K102558 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
- K102626 — VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01
Data sourced from openFDA. This site is unofficial and independent of the FDA.