FDA 510(k) clearances — page 783
clearances on record, most recent first.
Clearances — page 783
78,201–78,300 of 175,825- K012923 — ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
- K012949 — URETEX SUP PUBOURETHRAL SLING
- K012950 — MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
- K012967 — MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
- K013014 — BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
- K013034 — MODIFICATION TO: THERMACOOL IIA
- K010306 — MEDCOMP EXCELL SPLIT TIP CATHETER
- K012091 — PRO-FEMUR
- K012126 — THE SALICEPT ORAL PATCH
- K012336 — MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
- K012345 — NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
- K012446 — OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
- K012474 — ATAC PAK CPK REAGENT KIT
- K012592 — EASYTRAVEL
- K012948 — MODIFICATION TO VAXCEL DIALYSIS CATHETER
- K012986 — BIPOLAR IRRIGATION FORCEPS
- K012992 — MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES
- K012999 — TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
- K013002 — TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
- K013009 — BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2
- K013025 — MODIFICATION TO FLOUROLAB PLUS
- K994105 — HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
- K012383 — GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
- K012435 — ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
- K012946 — SUNLITELED MODEL #2810
- K012947 — SMARTFLOW
- K012952 — HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
- K012982 — COOLTOUCH VARIZOOM
- K013008 — NEXUS 2 MODIFIED
- K013104 — SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
- K003238 — SOLID STATE X-RAY IMAGING DEVICES
- K003322 — CODMAN BACTISEAL CATHETERS
- K011049 — EXPRESSSUITE
- K011794 — XLTEK LED GOGGLES, MODEL LED-01
- K012081 — DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
- K012144 — CYTOFLEX
- K012176 — ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
- K012227 — MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1
- K012238 — DOSERIGHT
- K012283 — SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE
- K012335 — BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS
- K012340 — BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
- K012366 — NAVIGUS II TRAJECTORY GUIDE
- K012466 — BIS/EEG MODULE
- K012709 — POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN)
- K012772 — CTS-485 ULTRASOUND IMAGING SYSTEM
- K012786 — POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)
- K012876 — DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K012914 — SONICWAVE SONIC PLAQUE REMOVER
- K013007 — BELLEGLASS HP ENAMEL 2
- K013111 — EXHALE PROBE
- K000035 — OMNICARE DENTAL IMPLANT SYSTEM
- K003191 — MIS IMPLANT SYSTEM DECIVE
- K003780 — VERTEX RECONSTRUCTION SYSTEM
- K010467 — UNIVERSAL DENTAL COPING (UDC)
- K010592 — AQUA WATER TREATMENT FOR HEMODIALYSIS
- K010619 — UCLA AND UNIVERSAL ABUTMENTS
- K010749 — ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
- K010882 — BLUE SKY BIO DENTAL IMPLANT SYSTEM
- K010913 — VYGON SPLIT CANNULA INTRODUCER
- K010949 — 2010 PLUS HOLTER FOR WINDOWS
- K011568 — RANDOX LIPOPROTEIN
- K011574 — UNIPLANT DENTAL IMPLANT SYSTEM
- K012114 — SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
- K012173 — DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
- K012270 — STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
- K012290 — RAPIDIA
- K012372 — SYSMEX UF-50
- K012428 — MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
- K012470 — MODIFICATION TO N PROTEIN STANDARD SL
- K012723 — PLATELETWORKS
- K012795 — DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
- K012797 — DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
- K012907 — LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
- K012911 — 3I LOCATER ABUTMENT SYSTEM
- K012913 — BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
- K012926 — MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
- K012934 — CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
- K012939 — AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
- K013077 — REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
- K013079 — REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
- K013080 — REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
- K013138 — ADC COMPACT PLUS
- K990323 — TE ME NA POLYSTIM NERVE STIMILATOR
- K010335 — SLENDERTONE FLEX, MODEL, 512
- K010478 — DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR
- K010712 — DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
- K010732 — VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
- K011405 — EXEL INJECTION PLUG WITH CAP
- K011800 — VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
- K012062 — PF2
- K012078 — RADIOFIX
- K012160 — COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
- K012202 — NUMARIS 4VA15A
- K012901 — COLOR-MONOGEN
- K013084 — AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
- K011877 — FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
- K011961 — POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
- K011970 — BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
- K012084 — SONOREAL 3D
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