FDA 510(k) clearances — page 395
clearances on record, most recent first.
Clearances — page 395
39,401–39,500 of 176,542- K131627 — CATHETER INTRODUCER SHEATH
- K131750 — AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
- K131912 — CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
- K132244 — N-FORCE FIXATION SYSTEM
- K132611 — MICROTABLE SYSTEM
- K132812 — UCP MULTI-DRUG TEST KEY CUPS
- K133022 — ZEDVIEW
- K133036 — APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
- K133400 — FLASH BITE
- K133459 — ELITE IBF
- K133754 — INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
- K133836 — OPTIGLAZE COLOR
- K133966 — MODEL-BASED RSA SOFTWARE
- K140113 — O2 NASAL CANNULA WITH CO2 MONITORING
- K140153 — VENTRIPOINT MEDICAL SYSTEM
- K130751 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K131900 — CONTEC ELECTROCARDIOGRAPH
- K132714 — ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)
- K132926 — VELOFIXTM INTERBODY FUSION SYSTEM
- K133254 — REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
- K133292 — ALLURA XPER FD; OR TABLE
- K133445 — ANGIOVAC CANNULA
- K133618 — DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
- K133619 — DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
- K133740 — SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
- K140208 — FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
- K140258 — IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL
- K140263 — INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
- K140266 — NMI PICC IV
- DEN080009 — AIRPURGE
- K131788 — HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE
- K132908 — TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
- K132936 — NOVOPORE DRESSING
- K133028 — RITHM ID ELECTROPHYSIOLOGY CATHETER
- K133117 — ANDON BLOOD PRESSURE CUFF
- K133339 — ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED; ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED
- K133383 — HEM-7320
- K133472 — SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
- K133525 — LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM
- K140099 — LIGHTHOUSE URINARY CATHETER
- K140126 — SONIC WINDOW
- K123193 — IPM WOUND GEL BIO
- K130618 — SFI-ANCHOR
- K131402 — VISICLEAR SMOKE EVACUATION SYSTEM
- K131659 — MOERAE VEIN PREPARATION KIT
- K132800 — SKINTELL
- K133547 — NXSTAGE SYSTEM ONE WITH NXVIEW
- K133668 — AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL
- K133937 — HEARTSCAN SOFTWARE
- K130255 — HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
- K130847 — JINTRONIX REHABILITATION SYSTEM (JRS)
- K130982 — LERADO, POWER WHEELCHAIR
- K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
- K131548 — SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
- K131605 — ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
- K131727 — CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
- K131777 — HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
- K131896 — SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
- K132064 — BIOMARC FIDUCIAL MARKER
- K132469 — THE BITE GUARD
- K132580 — COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
- K132763 — ADVANCED VIEWER
- K132810 — GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
- K133090 — OXICARE FINGERTIP PULSE OXIMETER
- K133119 — FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
- K133158 — ND: YAG LASER SYSTEM
- K133451 — FIXOS SCREW SYSTEM
- K133609 — THE DOME S6C
- K133654 — SCENIUM
- K133671 — ICONIX ALL SUTURE ANCHORS
- K133702 — PRESTO BREAST BIOPSY DEVICE
- K133715 — CHARLOTTE CLAW PLATE SYSTEM
- K133858 — TENSYN BAND
- K133999 — DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
- K140227 — MONODERM SURGICAL SUTURE
- K140283 — OSTEOMED EXTREMIFUSE SYSTEM
- K131876 — M SERIES PATIENT MONITOR
- K132553 — U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
- K132811 — SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
- K132957 — MADSEN ACCUSCREEN TYPE 1077
- K133115 — COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
- K133647 — EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
- K133773 — SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
- K133854 — ARTHREX IBALANCE TKA SYSTEM
- K140033 — TARGET3D FUSION
- K140178 — ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
- K123162 — U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL
- K123508 — TRINIAS
- K130650 — STATUS DS OXY
- K131598 — ANAL RECTAL OVERTUBE
- K131626 — EXCELERON BACTERIAL FILTERS
- K131770 — PRESSURE CONNECTING TUBE
- K131791 — IFA 40: HEP-20-10
- K132496 — ARTHROSURFACE TOEMOTION
- K132889 — FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
- K133018 — OSI Q SYSTEM ARTHROSCOPES
- K133385 — LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE
- K133517 — NEMUS 2 SYSTEM
- K133536 — EMERGE MEDICAL BONE PLATE SYSTEM
- K140034 — SUREFIRE GUIDING CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.