FDA 510(k) clearances — page 682
clearances on record, most recent first.
Clearances — page 682
68,101–68,200 of 176,637- K042228 — BEELINE MOTIV, PROPOLIS, PCA
- K042438 — SUPERDIMENSION/BRONCHUS
- K042516 — OTOMIMIX
- K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
- K042537 — SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX
- K042538 — SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX
- K042549 — MULTI CHEM CAL B
- K042550 — MULTI-LIPID CALIBRATOR
- K042557 — INNOJECT AUTO-INJECTOR
- K042566 — VASC-ALERT
- K042700 — IMAGE MEDICAL ACQUISITION STATION (IMAS)
- K042753 — MAMMOTOME MR BIOPSY SYSTEM
- K042811 — VIVOSORB SHEET, MODEL FS01
- K042969 — MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K040684 — T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303
- K041143 — RANDOX BARBITURATE ASSAY
- K041367 — TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
- K041464 — BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER
- K041891 — MININEPH HUMAN RHEUMATOID FACTOR KIT
- K042230 — POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
- K042572 — KENDALL CO2NFIRM NOW CO2 DETECTOR
- K042615 — CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE
- K042617 — 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
- K042619 — ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT
- K042717 — MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
- K042796 — ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
- K042815 — QUEST TUMOR MARKER CONTROL, MODEL 955
- K042836 — LIQUICHEK RETICULOCYTE CONTROL (A)
- K042874 — ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
- K042900 — K.E.P. CONNECTOR AND CLIP
- DEN040009 — HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
- K040354 — METAL/METAL HIP SYSTEM
- K041189 — ARTHREX TRIMIT FAMILY
- K041356 — ARTHREX TENODESIS SCREW FAMILY
- K042120 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K042210 — MSD SILO SPINAL SYSTEM
- K042337 — ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
- K042652 — TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR
- K042775 — INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
- K042776 — VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX
- K042778 — BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
- K042790 — CD HORIZON SPINAL SYSTEM
- K042798 — C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM
- K042905 — NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
- K041144 — RANDOX OPIATES ASSAY
- K041712 — 'RAPIDTEC 4' TEST
- K041968 — GENICON BIPOLAR FORCEPS MODEL # 600-005-005
- K042119 — POWDER-FREE VINYL PATIENT EXAMINTION GLOVES
- K042176 — AQUIFY LENS COMFORT DROPS
- K042307 — ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
- K042350 — TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
- K042434 — MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
- K042586 — BEST BREAST BRACHYTHERAPY APPLICATOR
- K042642 — AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
- K042739 — HI-ART SYSTEM
- K042844 — GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
- K042880 — JETSTREAM WORKSPACE
- K042948 — I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
- K040021 — SHUNTCHECK (PROMETHEUS 1)
- K040890 — 3M TEGADERM SILVER
- K042339 — NEOPLANT IMPLANT SYSTEM
- K042446 — QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
- K042496 — ADEPT ULTRALITE 532 LASER
- K042809 — CUFFPATCH
- K042837 — LIQUICHEK ELEVATED CRP CONTROL
- K042866 — AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
- K042867 — PHILIPS ORTHOPAEDIC APPLICATIONS
- K040301 — GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
- K041088 — TRIFUSION, MODEL 0609190/0659350
- K042069 — INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM
- K042093 — VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
- K042134 — VERSATILE 1 WOUND VACUUM SYSTEM
- K042196 — SAVEDENT BLUE
- K042670 — FUTURABOND NR
- K040959 — MENTOR GENESIS PENILE PROSTHESIS
- K041090 — HDL-EX SEIKEN ASSAY KIT
- K041100 — NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
- K041490 — IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
- K042095 — MAMMOTEST
- K042191 — DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
- K042193 — DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
- K042448 — DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
- K042460 — TI - SCREW ANCHOR SP
- K042480 — INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
- K042485 — TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
- K042598 — PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES
- K042695 — NCB PLATING SYSTEM
- K042720 — ON-BOARD IMAGER DEVICE
- K042724 — MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
- K042750 — QC-BEADS
- K042793 — ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
- K042839 — C-PET PLUS IMAGING SYSTEM
- K042903 — AUTOSPECS
- K031753 — KARATS MULTIPURPOSE SOLUTION
- K040750 — BIO-CHEM ANALYZER, MODEL 100
- K041271 — STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM
- K041478 — BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
- K041659 — C-BOOT
- K042006 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE
- K042275 — VISTAKON (SENOFILCON A) SOFT CONTACT LENS
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