FDA 510(k) clearances — page 717
clearances on record, most recent first.
Clearances — page 717
71,601–71,700 of 176,637- 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
- K024322 — EMBLA N7000
- K030394 — FLUID SAMPLE RETRIEVAL SYSTEM
- K032099 — SWISS MASTER LIGHT
- K032403 — SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
- K033108 — VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
- K033283 — CENTRA VIEW DEVICE LINK SYSTEM
- K031503 — AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
- K031750 — SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
- K031928 — BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)
- K032083 — NUVASIVE NEUROVISION JJB SYSTEM
- K032218 — ADEPT 1064/532/755 LASER
- K032220 — ADEPT 1064/532 LASER
- K032221 — ADEPT 1064/755 LASER
- K032307 — CAP BONE SUBSTITUTE MATERIAL
- K032348 — CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
- K032419 — QUANTEX D-DIMER
- K032433 — NASAL JACKS MASK
- K032482 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
- K032703 — INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10
- K032704 — INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30
- K033024 — MODIFICATION TO SUTURE CLINCH
- K033049 — CZR PRESS
- K033069 — DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205
- K033181 — SPR SYSTEM
- K023723 — FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1
- K030421 — ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
- K030627 — ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110
- K032164 — DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
- K032530 — MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
- K032576 — BIOPSY BREAST COIL, MODEL BBC
- K032698 — COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE
- K032820 — MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
- K032930 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
- K032996 — ELEKTA SYNERGY SYSTEM
- K033139 — GE MARLIN ULTRASOUND
- K022679 — RAPHAEL
- K023139 — ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE
- K031307 — FERRIS POLYMEM SILVER WOUND DRESSING
- K031329 — DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
- K031455 — CONKLUSION PEDICLE SCREW SYSTEM
- K031875 — INTER-OS LIMB LENGTHENER
- K031952 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
- K031953 — WEST NILE VIRUS ELISA IGG, MODEL EL0300G
- K032093 — PARIEFIX
- K032374 — POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
- K032392 — MORALES PROTRACTION FACEMASK
- K032420 — MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
- K032449 — THERMASSAGE ENERGY PRODUCT, MODEL HY5000
- K032477 — GE LOGIQ BOOK
- K032523 — T2 NAILING SYSTEM
- K032532 — TARAS THREADED FIXATION PIN
- K032559 — SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
- K032565 — CYNOSURE PHOTOGENICA VL
- K032580 — PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
- K032590 — MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
- K032632 — REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH
- K032682 — STS SCREW
- K032686 — ASCENSION MODULAR RADIAL HEAD
- K032714 — CARDICARE MODEL MT-301F & MT-301C
- K032726 — ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
- K032929 — MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822
- K032931 — PTA BALLOON CATHETER
- K032941 — AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
- K032989 — MEDI-HEAT INFANT HEEL WARMER
- K033254 — FORTE GAMMA CAMERA SYSTEM
- K023885 — COMBI-SCREEN, MODELS 10SL AND 11SL
- K030256 — ISO-ELASTIC CERCLAGE SYSTEM
- K030348 — BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE
- K032074 — LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS
- K032166 — BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
- K032312 — ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
- K032337 — HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
- K032351 — THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
- K032465 — MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
- K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
- K032917 — NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE
- K032974 — GE LOGIQ 5 PRO OR EXPERT
- K032985 — GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
- K033253 — S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
- K032289 — FIT CHECKER II
- K032819 — GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM
- K032939 — EPT CERTAINTY PREGNANCY TEST
- K032978 — MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
- K033121 — 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
- K033243 — ITI SYNOCTA MESO ABUTMENTS
- K033248 — HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
- K022809 — EZ SPLINT & EZ SPLINT PM
- K030668 — MODEL 3100 WRISTOX PULSE OXIMETER
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