FDA 510(k) clearances — page 489
clearances on record, most recent first.
Clearances — page 489
48,801–48,900 of 175,770- K093626 — INNOVANCE D-DIMER, MODEL OPBP09
- K100487 — EQUINOX CO2 LASER SYSTEM
- K100586 — VENUS FREEZE SYSTEM
- K100920 — MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES
- K101590 — DIGITAL FLAT PANEL X-RAY DETECTOR
- K101794 — ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA
- K102360 — ICESENCE 3
- K102790 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
- K100199 — ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT
- K101784 — MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX
- K102548 — FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE
- K093599 — ARROW ANATOMICAL SHOULDER SYSTEM
- K100246 — MAX-IF1000
- K100628 — PLASMALUXLS
- K101471 — AXLE INTERSPINOUS FUSION SYSTEM
- K101534 — CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
- K101539 — VITAL SIGNS MONITOR MODEL M3B
- K102170 — SIMPLEXA FLU A/B & RSV
- K102234 — A-DEC 200 DENTAL SYSTEM
- K102349 — AERODR SYSTEM
- K102505 — HTO PLATING SYSTEM
- K102690 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K093472 — TRINITY ACETABULAR SYSTEM
- K100721 — LOCKING BONE SCREW MODEL HCQ04, HCZ04
- K101163 — BIOGEL ORTHOPRO INDICATOR UNDERGLOVE
- K101291 — SCANVIEW HER2/NEU FISH SYSTEM
- K101574 — ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
- K102080 — DEPUY RECLAIM REVISION HIP SYSTEM
- 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; VENTIPLUS DISPOSABLE MANOMETER 0
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.