FDA 510(k) clearances — page 718
clearances on record, most recent first.
Clearances — page 718
71,701–71,800 of 175,825- K031625 — POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
- K031641 — VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
- K031707 — SK MED M201 PLUS MIXER
- K031768 — BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
- K031851 — DENTISEPTIC HPC
- K031877 — EMBRACE WET-BOND RESTORATIVE MATERIAL
- K031988 — AURORA DS
- K031993 — AURORA SR
- K032088 — MODIFICATION TO THERMACOOL TC SYSTEM
- K032128 — TERUMO AL8X ARTERIAL FILTER WITH X-COATING
- K032183 — IQ HYDROPHILIC GUIDE WIRE
- K032202 — DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I
- K021362 — LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
- K030671 — MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB
- K030758 — COACH 888
- K031309 — KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
- K031448 — RSV (RADIOLOGY SYSTEM VISIODENT
- K031480 — GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
- K031576 — SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1
- K031602 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML)
- K031704 — FILMLESS CLINIC
- K031829 — HEMOSIL FACTOR IX DEFICIENT PLASMA
- K032123 — SHOCKWAVE SUSPENSION WHEELCHAIR
- K032188 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY
- K030058 — EARLYDETECT MENOPAUSE TEST FOR FSH
- K030268 — NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS
- K030278 — SAUFLON MULTIPURPOSE SOLUTION - NO RUB
- K031194 — SPIROSOFT
- K031381 — UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
- K031411 — MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
- K031534 — CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
- K031656 — BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
- K031699 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML
- K031727 — PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN
- K031731 — MR FIBER OPTIC ECG GATING SYSTEM
- K031757 — PEEK TETRIS SPINAL IMPLANT
- K031780 — VERTE-STACK SPINAL SYSTEM
- K031987 — POWERHEART AED G3, MODEL 9300
- K031991 — DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
- K032045 — 8 CHANNEL CARDIAC PHASED ARRAY COIL
- K032058 — MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
- K032082 — AURORA
- K032089 — ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
- K031550 — REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE
- K031647 — BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
- K031658 — BENCO SPHERICAL
- K031861 — MIX2VIAL TRANSFER DEVICE
- K031891 — VIRTUOSAPH
- K032062 — STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230)
- K024367 — SINCLAIR WOUND AND SKIN EMULSION
- K030170 — REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
- K031475 — OSSEOTITE NT CERTAIN IMPLANTS
- K031881 — AIRBRUSH LIPOSCULPTOR SYSTEM
- K031969 — DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
- K032007 — GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR
- K030221 — MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR
- K030766 — OXINIUM FEMORAL HEADS
- K030912 — THYRO TEST
- K030962 — DPX SERIES BRAVO DUO BONE DENSITOMETER
- K031182 — ELI 200+ AUDICOR
- K031328 — RECOVERY FILTER SYSTEM, MODEL RF-048F
- K031394 — AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE
- K031500 — EXCEL PRIMARY SOLUTION SET
- K031554 — S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
- K031580 — NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
- K031776 — MC2X MULTI-STAGE VENOUS CANNULA
- K031854 — VINYL EXAM GLOVES, POWDER-FREE, YELLOW
- K031910 — STAINLESS STEEL AQUATIC WHEELCHAIR
- K031959 — STRYKER PLATING SYSTEM PERIARTICULAR PLATES
- K031979 — CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
- K031980 — MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
- K031981 — 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
- K031999 — ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
- K032052 — UC-PLUS SOLUTION UNICONDYLAR KNEE
- K032059 — MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
- K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
- K032182 — GE LOGIQ 7, MODEL 2354858
- K030239 — MEGATECH SCIENTIFIC FACE MASK
- K031040 — THERIFIL BONE FILLER
- K031345 — NOBEL DIRECT, MODELS 30937, 30938
- K031581 — NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG
- K031624 — TINNITUS RX
- K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
- K031837 — MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
- K031941 — HOFFMANN II COMPACT BALTIMORE COUPLING
- K031986 — ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS
- K031998 — MODEL J-5 MVO-MONITOR
- K032013 — COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
- K032081 — KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60
- K032174 — WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A
- K014074 — HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION
- K023044 — MODEL 9600, AVANT PULSE OXIMETER
- K030973 — PICOSAT II SPO2 PULSE OXIMETRY MODULE
- K031173 — NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
- K031222 — SCANLUBE
- K031256 — XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE
- K031390 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
- K031459 — RAPIDO CUT-AWAY CUTTER
- K031512 — EMIT II PLUS COCAINE METABOLITE ASSAY
- K031575 — LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
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