FDA 510(k) clearances — page 724
clearances on record, most recent first.
Clearances — page 724
72,301–72,400 of 175,825- K031378 — FRESENIUS ULTRAFLUX HEMODIALYZER
- K031403 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1
- K031406 — EXOJET TISSUE MANAGEMENT SYSTEM
- K031508 — SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
- K031543 — STARCAST DENTAL ALLOYS
- K031552 — MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
- K022274 — CARECOMPANION PATIENT STATION & NURSE STATION
- K024278 — PACEART SYSTEM
- K030663 — TOKUYAMA SOFRELINER TOUGH
- K030699 — VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC
- K030751 — IPACS PRISM
- K030781 — KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
- K031011 — LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
- K031139 — PREMIER III PHASED ARRAY CTL SPINE COIL
- K031143 — ALPHA 5000 WRIST COIL
- K031172 — SPIRIT III TOTALSENSE CARDIAC COIL
- K031286 — SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K031481 — THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20
- K022448 — WATER PURIFICATION SYSTEM
- K023068 — PAPILLON MASK SET
- K023662 — PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
- K030667 — ENCORE ANTERIOR SPINAL STAPLE SYSTEM
- K031148 — IN-VISION IMAGING SYSTEM
- K031219 — MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
- K012889 — BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
- K023937 — COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM
- K030612 — GENESIS II TOTAL KNEE SYSTEM
- K030618 — WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
- K030884 — APTUS BLUE
- K031610 — REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
- K030039 — PATHWAY STM-10 PELVIC FLOOR STIMULATOR
- K030230 — AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)
- K030398 — CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
- K030592 — GAMBRO POLYFLUX, MODEL 140H, 170H, 210H
- K030642 — DEFLECTING URETERAL ACCESS SHEATH
- K030664 — AMSURE FOLEY INSERTION TRAY
- K030712 — AMSURE URETHRAL CATHETERIZATION TRAY
- K030728 — FYRELINK VL
- K030827 — NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204
- K030889 — ULTRAEKOGEL MODELS EK 2000 & EK 2001
- K030930 — OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N
- K030956 — NAVIGATOR URETERAL ACCESS SHEATH SET
- K031076 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
- K031117 — SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM
- K031120 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
- K031171 — DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES
- K031209 — GE 1.5T 8 CHANNEL TORSO COIL
- K031217 — GMRS PRESS FIT STEMS WITH PUREFIX HA
- K031262 — ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
- K031344 — RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE
- K031361 — CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
- K031371 — SAPHYRE BIPOLAR ABLATION PROBES
- K031514 — MODIFICATION TO TRUPEAK PEAK FLOW METER
- K020738 — AVITA BF1 (VITALIO) BODY FAT ANALYZER
- K022211 — HLS UNI EVOLUTION PROSTHESIS
- K023566 — CODMAN ISOCOOL BIPOLAR FORCEPS
- K023823 — EASYCUP
- K030623 — SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
- K030649 — DRI COTININE EIA ASSAY
- K030835 — 'RAPID ONE' - PROPOXYPHENE TEST
- K030845 — COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
- K031046 — THERMACOOL TC SYSTEM
- K031110 — APEX MODULAR ACETABULAR CUP
- K031274 — MODEL 5071 MYOCARDIAL PACING LEAD
- K031292 — MODIFICATION TO FOSSA URETERAL STONE SWEEPER
- K031317 — SMART 2940 D ER: YAG LASER
- K031334 — TEXAS T - PLATE
- K031379 — DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531
- K031388 — MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
- K031404 — DIGNITY OPHTHALMIC SURGICAL SYSTEM
- K031430 — CEMEX SYSTEM FAST
- K031469 — AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
- K031518 — EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,
- K030534 — VARISEED 7.1
- K030544 — RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
- K030558 — MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
- K030576 — ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
- K030589 — MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
- K030617 — PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
- K030805 — MYTHOS 500
- K030812 — DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
- K030828 — TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
- K031001 — ACMI VISTA CTR BIPOLAR LOOP ELECTRODE
- K031020 — FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
- K031034 — SPIN DOWN RAPIDFLAP
- K031079 — EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE
- K031081 — EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS
- K031082 — EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK
- K031184 — COOL TOUCH 3
- K031206 — RADIOMED SOFT TISSUE MARKER
- K031447 — CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
- K022849 — BODY CLOCK TENS N' TONE
- K022998 — HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
- K030131 — OSSATURA BCP BONE VOID FILLER
- K030355 — COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202
- K030356 — COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
- K030494 — SR-130
- K030497 — FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
- K030502 — 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
- K030507 — T.E.A.R. TECH3 MODEL #44TT03
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