FDA 510(k) clearances — page 708
clearances on record, most recent first.
Clearances — page 708
70,701–70,800 of 175,825- K033367 — TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464
- K033416 — SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE
- K032481 — THERATEARS CONTACT LENS COMFORT DROPS
- K032597 — BISCEM GI
- K032788 — VITEK 2 GRAM NEGATIVE GATIFLOXACIN
- K033274 — GIARDIA II
- K033277 — HYDRAGEL CSF ISOFOCUSING KITS
- K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER
- K031042 — ATAC HEMOGLOBIN A1C REAGENT KIT
- K031708 — OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM
- K031946 — EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
- K032662 — GUTTAFLOW
- K032764 — BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
- K032804 — CRYOCHECK WEAK LUPUS POSITIVE CONTROL
- K033346 — SPI EASY DENTAL IMPLANT PROTECTIVE CAP
- K013452 — DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS
- K024013 — SUN-RAIN ULTRASONIC THERAPY, SU-100
- K030358 — KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K030683 — NIPRO DISPOSABLE SYRINGES
- K031369 — MERCATOR HEALTHCARE MALE LATEX CONDOM
- K031446 — JABES ELECTRONIC STETHOSCOPE
- K031862 — SPINERX-LDM
- K031963 — CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD
- K032145 — AUDICOR UPGRADE SYSTEM
- K032363 — ZOLL M SERIES NIBP OPTION
- K032388 — BONE CEMENT RADIO-OPACIFIER
- K032398 — PLUS PIVOT LINK UNIVERSAL SYSTEM
- K032426 — GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
- K032527 — HEDROCEL VERTEBRAL BODY REPLACEMENT
- K032564 — DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
- K032573 — DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
- K032711 — VITEK GRAM NEGATIVE GATIFLOXACIN
- K032738 — VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
- K032766 — VITEK 2 GRAM POSITIVE LINEZOLID
- K032993 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS
- K033037 — MODIFICATION TO GLOBALCARDIO
- K033068 — IONOFIL COLOR AC
- K033127 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
- K033130 — PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
- K033209 — FUKUDA DENSHI MODEL FF SONIC UF-750XT
- K033217 — PHERON PTA CATHETER
- K033263 — K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT
- K033264 — MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
- K033305 — INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
- K023509 — DBB-05 HEMODIALYSIS DELIVERY SYSTEM
- K030082 — POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851
- K031473 — RATIONAL IMAGING PACS
- K031681 — STERISIL ANTIMICROBIAL TUBING AND BOTTLE
- K031684 — TOPKIN WOUND DRESSING
- K031819 — DIO-DENT 10 DENTAL DIODE LASER
- K031838 — PROFUSION BONE VOID FILLER KIT
- K032002 — FERTELL FEMALE FERTILITY TEST
- K032105 — ENDOHELIX ENDARTERECTOMY DEVICE
- K032366 — BONESOURCE HAC FAST SETTING CEMENT
- K032385 — GLOBAL PRESS-FIT STEM
- K032499 — A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS
- K032513 — T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
- K032656 — GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X
- K032676 — ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR
- K032731 — MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS
- K032791 — GLYCOHEMOSURE HBA1C CONTROL
- K032798 — DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
- K032915 — ADVANTAGE 4D OPTION
- K033016 — PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892
- K033125 — HANDIVIPP
- K033131 — NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
- K033141 — MECHANICAL WHEEHCHAIR
- K033172 — CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
- K033194 — INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
- K033211 — ENSITE SYSTEM
- K033212 — LIFESTENT SDS BILIARY ENDOPROSTHESIS
- K033257 — ARTHROCARE ENT PLASMA WANDS
- K023000 — HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES
- K030120 — AMSURE FOLEY CATHETER
- K031341 — STICK FLOW
- K032024 — POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K032084 — POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
- K032119 — PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS
- K032387 — TRIVEX SYSTEM
- K032405 — GIVEN DIAGNOSTIC SYSTEM
- K032442 — KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
- K032599 — MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM
- K032660 — XTRAK SUPPORT CATHETER
- K032748 — VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
- K032962 — AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
- K033065 — SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
- K033078 — DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
- K033088 — SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1
- K033126 — MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
- K033140 — NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
- K033311 — ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
- K033315 — SUPEROPEN 0.23T, MODEL NAM-P023A
- K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
- K031989 — ORTRAUTEK ORTHOGNATHIC SYSTEM
- K032356 — NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
- K032484 — MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
- K032485 — MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
- K033221 — KAVO EVEREST ZH-BLANK
- K033295 — BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
- K022730 — PERFADEX SOLUTION FOR LUNG PRESERVATION
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