FDA 510(k) clearances — page 593
clearances on record, most recent first.
Clearances — page 593
59,201–59,300 of 176,637- K071965 — I-SURGE
- K072153 — QUICKIE QX MANUAL FOLDING WHEELCHAIR
- K072269 — ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
- K060676 — NES REPROCESSED ENDOSCOPIC TROCAR
- K062028 — CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
- K071118 — GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE
- K071145 — NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
- K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
- K071348 — EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
- K071391 — PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
- K071688 — RELIANCE S.E.P.
- K071689 — DEVILBISS INTELLIPAP MODEL DV 5 SERIES
- K071854 — AQUADEX FLEXFLOW SYSTEM
- K071911 — CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR
- K072152 — JUNIPER CLN1 DERMAL COOLING DEVICE
- K072208 — MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
- K072222 — SPY FLUORESCENT IMAGING SYSTEM
- K072232 — GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
- K072272 — HONEYWELL HOMMED CENTRAL STATION 4.0
- K070282 — ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
- K071196 — DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
- K071221 — SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
- K071577 — BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
- K071910 — NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
- K071976 — VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES
- K072167 — COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE
- K072281 — NEXGEN PROLONG ALL-POLY PATELLA
- K070895 — VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK
- K071661 — ALPHAONE BIOFEEDBACK SYSTEM
- K071951 — COMFY SERIES: EV-804, EV-805 & EV-806
- K071966 — 1.5T MRGFUS PELVIC COIL
- K072160 — NEXGEN TRABECULAR METAL TIBIAL TRAY
- K072164 — DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
- K072177 — ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM
- K072183 — ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
- K070531 — ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
- K071016 — DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
- K071418 — DANA 3CC SYRINGE INSULIN RESERVOIR
- K071817 — OSTEOGRAF/N-300
- K071824 — ACME TALON PEDICLE SCREW
- K072085 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K070419 — OPACIDEN OPA REAGENT STRIPS
- K070549 — STRAUMANN P.004 RC GOLD ABUTMENT
- K070623 — PHARMAPAC LUBRICATING JELLY
- K070630 — HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE
- K070754 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155
- K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
- K071080 — ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M
- K071167 — FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560
- K071168 — THE PORTABLE ANSISCOPE
- K071225 — INNOVASA STAT*SEAL TOPICAL HEMOSTAT
- K071299 — IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
- K071328 — VISUALASE THERMAL THERAPY SYSTEM
- K071470 — IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
- K071564 — MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
- K071584 — OASIS RELEASE 1.0
- K071606 — BIOSIGN CENTRAL STATION
- K071660 — VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900
- K071858 — DENTAL MATRIX BAND
- K071863 — ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)
- K072006 — DAR-9400F
- K072108 — MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
- K072127 — DOMINATOR
- K072172 — JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE
- K063453 — VERTEFIX PEDICLE SCREW SPINAL SYSTEM
- K070057 — EASYRA CLINICAL CHEMISTRY ANALYZER
- K070206 — DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
- K070579 — STORZ SLX-F2 STORM TOUCH
- K071072 — SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
- K071427 — DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
- K071538 — ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
- K071551 — QUICKBRIDGE TM CYLINDER AND CAP
- K071555 — FORTAGEN ORAL MEMBRANE
- K071846 — MODIFICATION TO EZ HUBER SAFETY INFUSION SET
- K071848 — IPS INLINE POM SYSTEM
- K072106 — 150W CERALAS D 980NM DIODE LASER
- K072132 — LDR SPINE ROI-T SYSTEM
- K072147 — DEN TEK COMFORT FIT NIGHTGUARD
- K072217 — ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
- K072285 — ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM
- K072353 — PORTABLE ECSCOPE
- K063635 — SBI FOREFOOT SET
- K070661 — VITALCOR FEATHERWEIGHT VASCULAR CLAMPS
- K071367 — FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
- K071852 — AAP APS SYSTEM
- K072047 — MHI-TM2000 LINEAR ACCELERATOR SYSTEM
- K072073 — VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR
- K072075 — MODIFICATION TO GE LOGIQ A3
- K072088 — FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS
- K072205 — VISAGE PACS/CS, RELEASE VERSION 5.0
- K072266 — ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM
- K070338 — RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS
- K071485 — TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888
- K071492 — FIRSTVIEW
- K071806 — ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K071373 — STRYKER SPINE XIA III SPINAL SYSTEM
- K071656 — SBI ARTFIX
- K071751 — LIFESYNC ADAPTER, MODEL LS-302
- K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
- K072196 — ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT
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