FDA 510(k) clearances — page 425
clearances on record, most recent first.
Clearances — page 425
42,401–42,500 of 175,770- K122459 — PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
- K122535 — FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
- K122613 — VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
- K122821 — CELLTRACKS AUTOPREP SYSTEM
- K122839 — ZOLL SUREPOWER SINGLE BAY CHARGER
- K122869 — MILAGRO INTERFERENCE SCREWS
- K122958 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
- K122960 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
- K123094 — ORTHODONTIC CERAMIC BRACKETS
- K123156 — GORE FLOW REVERSAL SYSTEM MODEL GFRS073
- K123355 — AMPLIVUE C. DIFFICILE ASSAY
- K123448 — AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
- K123492 — DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
- K123493 — VEX-S 100W INTRAORAL X-RAY SYSTEM
- K123503 — DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM
- K123565 — PRESTO 1000 SYSTEM
- K112695 — CRYOTOP
- K120956 — VSP SYSTEM
- K121152 — SURGICAL GOWN, SMS
- K121508 — LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
- K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
- K122000 — HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
- K122213 — ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K122423 — VASU-PICC
- K122555 — STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE
- K122571 — MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
- K122649 — NAVIGATOR HD URETERAL ACCESS SHEATH SET
- K122855 — TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
- K123120 — LENSX LASER SYSTEM
- K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEM
- K123352 — S4 SPINAL SYSTEM
- K113394 — MAVRIC SL
- K113693 — NIXALL TM WOUND AND SKIN CARE
- K120146 — QUARK SERIES
- K120237 — BPA-FREE MICROHYBID COMPOSITE
- K120356 — NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
- K120791 — AMBIENT TURBOFLASH 90 IFS
- K120866 — DA01 BLOOD GLUCOSE MONITORING SYSTEM
- K121266 — CARDIOSCOPE
- K121620 — ULTRASONIC SURGERY
- K121843 — NP-CAST ABUTMENT SYSTEM
- K122158 — PBP TOTAL HIP SYSTEM
- K122268 — ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS
- K122421 — TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID
- K122892 — MTA2 ROOT AND PULP MATERIALS
- K122980 — GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ
- K123113 — L.A.M. IMP WOUND GEL
- K123317 — EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
- K123479 — PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
- K120282 — CARDNAV
- K120953 — PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
- K121391 — INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS
- K122018 — OP300
- K122489 — EMERGE MEDICAL SOLID BONE SCREWS
- K122740 — JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN
- K122828 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
- K122835 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
- K122874 — POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
- K120454 — SAFEAIR SMOKE PENCIL,
- K120502 — PC-60NW FINGERTIP OXIMETER
- K120813 — BLOOD GLUCOSE MONITORING SYSTEM
- K120932 — OPELASER PRO II AND THE OPELASER LITE II
- K121495 — LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
- K121703 — LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
- K122105 — SMI CARDIOVASCULAR PATCH
- K122330 — FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE
- K122475 — ZQUIET PRO-PLUS
- K122546 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K122582 — DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)
- K122684 — REVERSE MEDICAL MICROCATHETER
- K122733 — V2F ANTERIOR FIXATION SYSTEM
- K122742 — NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
- K122760 — AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
- K122845 — ES2 SPINAL SYSTEM MODEL 48280XXXX
- K122861 — XTOOL
- K122953 — OMNIPOD INSULIN MANAGMENT SYSTEM
- K123005 — DDRVERSA MOTION
- K123152 — VITESSE 3.0
- K123265 — RMGI LOW VISCOSITY
- K123273 — HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)
- K123278 — IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
- K123446 — TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
- K123462 — OCELOT CATHETER
- K112079 — APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
- K120770 — QT GUARD PLUS ANALYSIS SYSTEM
- K120858 — IMPLANT BAR
- K121067 — EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE
- K121341 — FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
- K121382 — WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
- K121440 — ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
- K122034 — MRJ 3300
- K122097 — PATRIOT SPACERS
- K122101 — CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
- K122322 — PIEZOSURGERY TOUCH
- K122432 — ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
- K122787 — COMFORT EZ
- K122852 — PHYSIOSTAR NFC
- K121640 — ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
- K121663 — CLARITY
- K122088 — MERIT ONE SNARE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.