FDA 510(k) clearances — page 618
clearances on record, most recent first.
Clearances — page 618
61,701–61,800 of 176,637- K052599 — 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
- K052742 — HEPASPHERE MICROSPHERES
- K062043 — BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
- K062135 — ART SHIELDED BREAST APPLICATOR
- K062422 — HUMERAL HEAD, MANUAL DRIVER
- K062440 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
- K062757 — XERON PACS
- K063079 — I-STOP TRANS OBTURATOR MALE SLING
- K063093 — SECTRA WORKSTATION, VERSION 11.1
- K053225 — CELLU M6 KEYMODULE I
- K061908 — NICOLETONE SYSTEM V32 AMPLIFIER
- K062412 — CRYOMATIC
- K062807 — TSRH SPINAL SYSTEM
- K062886 — ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
- K063083 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K060421 — SONARA; SONARA/TEK
- K061233 — SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
- K061944 — POLY-CHEM CREATININE
- K061993 — EQUIVITAL, MODEL EQ-01
- K062454 — MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES
- K062455 — PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
- K062469 — VOYAGER 12
- K062482 — VENTED VIAL ADAPTER TRANSFER DEVICE
- K062597 — TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA
- K062671 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
- K062715 — SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW
- K062999 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
- K063067 — CONFIDENCE FENESTRATED INTRODUCER NEEDLE
- K063117 — MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
- K063173 — MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
- K063184 — MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION
- K063189 — TSX-301A, AQUILION ONE CT SYSTEM
- K060987 — OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31
- K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
- K061316 — MEDLINE SURGICAL SPONGE SCANNER
- K061796 — HEPATOSTAT SET, MODEL 760X
- K062030 — US SYSTEM
- K062081 — LITHOGOLD
- K062174 — MODIFICATION TO EXPEDIUM SPINE SYSTEM
- K062341 — MALE REMEEX SYSTEM
- K062343 — GRANDIO FLOW TRY-IN
- K062642 — RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
- K062713 — ADHESIVE DC ACTIVATOR
- K062740 — JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
- K062754 — GAS MODULE SE, MODEL 0998-00-0481-02
- K062914 — HEM-O-LOK LIGATION CLIP
- K062917 — STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50
- K063006 — GE LOGIQ WORKS
- K063029 — EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
- K063031 — PRISM VIEW, MODEL
- K063039 — XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM
- K063075 — NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS
- K063130 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0
- K063162 — GOLDEN LITEWAY
- K061639 — ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
- K061830 — STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
- K062021 — KOWA VX-10I
- K062051 — SS SYSTEM
- K062323 — DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
- K062548 — MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
- K062614 — VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)
- K062816 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K062876 — PRIMACONNEX CERAMIC ABUTMENTS
- K063033 — MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT
- K063099 — MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
- K063101 — MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML
- K061645 — MAGPRO, MODEL R30
- K061925 — MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS
- K062015 — CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
- K062029 — ANATOMICAL SHOULDER FRACTURE SYSTEM
- K062267 — OXYLOG 3000
- K062321 — SMARTLIPO ND:YAG LASER
- K062472 — OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115
- K062476 — CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
- K062570 — PATIENT CONTOURED MESH (PCM)
- K062598 — IMT.LAB SOFTWARE
- K062743 — UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0
- K062861 — ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
- K062863 — OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM
- K062995 — M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
- K063002 — ALTRA PRESS-FIT HIP SYSTEM
- K063191 — HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
- K060756 — MEDLOG, MODEL 1-0-10
- K061234 — GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
- K061922 — BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
- K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL
- K062967 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K063024 — LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS
- K052267 — SUPERCATH V
- K060836 — VISTADENT OC - VERSION 4
- K060889 — SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
- K061153 — GYNESONICS EC6 TRANSDUCER
- K062010 — RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
- K062016 — RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
- K062068 — INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0
- K062376 — DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
- K062438 — BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
- K062477 — AMICAS VISION SERIES PACS, MODEL 4.3
- K062490 — VISAGE PACS/CS, RELEASE VERSION 4.1
- K062653 — MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
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