FDA 510(k) clearances — page 425
clearances on record, most recent first.
Clearances — page 425
42,401–42,500 of 176,542- K130142 — FLIXENE IFG VASCULAR GRAFT
- K130210 — MEDELA THOPAZ
- K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
- K120014 — STA- COAG CONTROL (N+ABN) PLUS
- K121622 — NIDEK RS-3000
- K121747 — FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
- K121933 — NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
- K122534 — IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
- K122907 — FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
- K123161 — SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
- K123186 — RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
- K123557 — EASYCARE ONLINE
- K123782 — PARAGON HIP SYSTEM
- K123783 — ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
- K123929 — BEGOPAL+
- K123933 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
- K123948 — CHINA NAILS AND ACCESSORIES
- K130124 — CATALYST II AND III
- K130351 — NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER
- K130435 — VERSAPORT V2 BLADELESS OPTICAL TROCAR
- K120089 — BIOGENESIS IMPLANT SYSTEM
- K121156 — AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
- K122412 — VISIOFOCUS
- K122602 — NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS
- K123169 — ORALID
- K123370 — EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA
- K123416 — INSIGNIA WITH ITERO
- K123522 — OPTIMA MR450W
- K123897 — K SERIES CPAP SYSTEMS
- K124053 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
- K130091 — PULMOSAL
- K130234 — NUVON VITALS CHARTING SYSTEM
- K130251 — ESOPHAGUS BOUGIE SET
- K130280 — CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
- K130333 — CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
- K130359 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
- K130493 — CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
- K130520 — CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
- K121685 — SOPROCARE
- K121864 — PERKINELMER 226 SAMPLE COLLECTION DEVICES
- K122071 — GETINGE 400HC-E / SERIES STEAM STERILIZER
- K122113 — MEMORY METAL STAPLES, EASYCLIP
- K122634 — IODOFOAM IODOPHOR FOAM DRESSING
- K122981 — RAYSCAN A-EXPERT 3D
- K123345 — DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
- K123584 — SYNGO, CT BONE READING
- K123862 — ZIMMER NEXEL TOTAL ELBOW
- K123939 — S4 SPINAL SYSTEM
- K130153 — HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
- K113164 — DISCOVERY TMAX MANUAL WHEELCHAIR
- K121825 — CS-MAG II
- K121904 — GYNECOLOGY STERILIZATION TRAY
- K122736 — DX-D IMAGING PACKAGE
- K123073 — DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
- K123487 — GSO GS1 CANNULATED SCREW SYSTEM
- K123614 — SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
- K123702 — SILEX SACROILIAC JOINT FUSION SYSTEM
- K123815 — SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
- K123875 — AAP RADIUS SET 2.5
- K130113 — PICCOLO LACTATE TEST SYSTEM
- K130395 — STEREOS WORKSTATION
- K113042 — REVOIS IMPLANT SYSTEM
- K113636 — BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
- K121285 — ORAVAN OSA
- K122189 — QUIDEL MOLECULAR RSV + HMPV ASSAY
- K122306 — SYNOVIS COLLAGEN MATRIX (TBD)
- K122468 — ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO
- K122469 — ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
- K122806 — IMAGE WORKS PANOURA
- K123151 — ENDOSEE MODEL 8000 U-SCOPE
- K123212 — ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
- K123228 — INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
- K123725 — FASTPACK CONTROL KIT
- K123776 — POLARIS 100/200
- K123955 — QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
- K123998 — QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
- K130034 — UNI-PICC
- K130128 — TRINITY ACETABULAR SYSTEM
- K121511 — MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
- K122476 — LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
- K123081 — BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40
- K123136 — GENESIS HEALTH RECORD SYSTEM, (GHRS)
- K123344 — K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
- K123350 — ECLIPSE SOFT TISSUE FASTENER
- K123395 — NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
- K123411 — LITTLE ANGELS SWADDLING BLANKET
- K123554 — SHUNTCHECK
- K123677 — DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
- K123694 — SAM JUNCTIONAL TOURNIQUET
- K124007 — SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
- K124039 — HERO GRAFT
- K130283 — EVRF SYSTEM
- K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
- K122513 — CLEARED UNDER GRAFTON II EDBM
- K122847 — KANGAROO NASAL MASK
- K123373 — NAUTILUS SPINAL SYSTEM
- K113717 — ULTRASONIC SCALER
- K120740 — COLS® FIXATION SYSTEM
- K121488 — JMS SAFE WING CATH (SWC)
- K121769 — DENTOCORE / DENTOCORE BODY
Data sourced from openFDA. This site is unofficial and independent of the FDA.