FDA 510(k) clearances — page 445
clearances on record, most recent first.
Clearances — page 445
44,401–44,500 of 175,770- K120741 — VOLUSON S6, VOLUSON S8
- K120746 — DISPOSABLE POWDER FREE VINYL EXAM GLOVES
- K120764 — EPIFLO(R)
- K120935 — SECURACATH
- K120962 — PATHASSIST LIGHT FIBER
- K121106 — TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET
- K110835 — GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
- K112153 — IROOT 100 MINI
- K112342 — FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
- K113796 — SOLITAIRE-C CERVICAL SPACER SYSTEM
- K120437 — TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM
- K120517 — DEPUY PULSE CERVICAL CAGE SYSTEM
- K120939 — AERONEB PRO
- K121070 — C-QUR RPM MESH
- K111085 — SHARPS TANK REUSABLE SHARPS CONTAINER
- K112611 — SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
- K112761 — ZOLL PROPAQ MD
- K113485 — ELECTROCARDIOGRAPH
- K113585 — NASAL/EPISTAXIS PACK
- K113760 — VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK
- K120908 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K120979 — CAREFUSION NICOLET EDX
- K103230 — AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
- K112094 — BRAIN BIOPSY NEEDLE
- K112734 — APLAN A.V. FISTULA NEEDLE SET
- K120015 — OSTEOMED WRIST PLATING SYSTEM
- K120055 — HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS
- K120086 — CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM
- K120231 — EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
- K120452 — FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
- K120589 — MILAGRO INTERFERENCE SCREWS
- K120645 — PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
- K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEM
- K120664 — PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
- K120757 — SLEEPWEAVER ELAN NASAL CPAP MASK
- K121004 — APEX KIRSCHNER WIRES AND STEINMANN PINS
- K111824 — FLAT PANEL DETECTOR
- K112315 — HOME PREGNANCY TEST
- K113857 — SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
- K120207 — VISIA
- K111425 — OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
- K112666 — SALINE WOUND WASH
- K112795 — PALTOP DENTAL IMPLANT SYSTEM
- K112992 — EARLOGIC OAE TESTER
- K113240 — 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W
- K113611 — RAPID PROGRAMMER
- K113633 — MCKESSON ANESTHESIA CARE
- K113662 — FENESTRATED NERVE BLOCK NEEDLE
- K113719 — SAFETY SCREW CONNECTOR
- K113778 — EXCELSIOR XT-27 MICROCATHETER
- K113780 — EASYCARE TX SYSTEM (CONNEXUNS)
- K120037 — BLUWHITE DIAMOND DENTAL BURS MODIFIED
- K120051 — SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
- K120208 — CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
- K120313 — NEO CR KNEE SYSTEM
- K120428 — GORE DRYSEAL SHEATH
- K120853 — NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
- K120868 — MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
- K120872 — ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
- K120942 — PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC
- K111464 — PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
- K111872 — VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
- K112286 — NOVAC 11
- K112536 — SONICISION STERILIZATION TRAY
- K112843 — PULSE OXIMETER
- K113494 — NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
- K113789 — MODULAR PROXIMALLY FLUTED HIP STEM
- K113831 — PRIMUS HEARING INSTRUMENT TEST UNIT
- K120063 — VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
- K120076 — RESOLUTIONMD WEB
- K120182 — NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
- K120196 — OLEA SPHERE
- K120201 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
- K120234 — EZONO 3000
- K120255 — PHILIPS MICRODOSE
- K120316 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K120407 — 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240
- K120699 — DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
- K120718 — INSTAPACS/INSTARISPACS
- K120722 — RIVAL PTA DILATATION CATHETER
- K120818 — OTIS-C PLUS
- K120859 — PRE-LOADED GOLD VISICOIL CK MARKER
- K120863 — WHOLEY GUIDE WIRE SYSTEM
- K120880 — ORBIT
- K120971 — ATLAS PTA BALLOON DILATATION CATHETER
- K121010 — M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
- K121019 — OPTIMA NM/CT 640
- K102428 — WUNDER TEST
- K112440 — AB DENTAL DEVICES IMPLANTS AND ACCESSORIES
- K112696 — TWIN PEAKS LUMBAR CAGE
- K112816 — ZHENJIANG ASURE MECHANICAL WHEELCHAIR
- K113332 — ON CALL CHOSEN LANCING DEVICE
- K113398 — NEXUS TKO-6, LUER-ACTIVATED DEVICE
- K113488 — JAZZY ELITE 6
- K113586 — SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
- K120531 — VERSAFITCUP CC TRIO-ADDITIONAL LINERS
- K120881 — MANTARAY GUIDEWIRES
- K103037 — IND URINARY TRACT INFECTION (UTI) TEST STRIPS
- K110840 — LIAC
- K111999 — HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.