FDA 510(k) clearances — page 661
clearances on record, most recent first.
Clearances — page 661
66,001–66,100 of 176,637- K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
- K051262 — ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000
- K051518 — UNITY NETWORK ID
- K051530 — MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.
- K051559 — IMASK, MODELS 100, 200 AND 300
- K051668 — THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
- K042472 — BD DIRECTIGEN EZ FLU A + B
- K050444 — NOBELREPLACE ADAPTER, MODEL 32412
- K050449 — QUANTUM VERTEBRAL BODY REPLACEMENT
- K050507 — SMARTECH, MODEL HOLI I
- K050690 — CONNEXUS
- K050793 — LANDLEX MODEL S400X
- K050832 — FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
- K050854 — PALACOS LV+G
- K050855 — PALAMED G
- K050966 — PIVOT BIPOLAR FEMORAL HEAD
- K051098 — PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
- K051323 — MERETE TWISTCUT SNAP-OFF BONE SCREW
- K051358 — NATURE-CRYL HI PLUS
- K051372 — POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR)
- K051490 — GE OEC EVERVIEW 7500
- K051524 — LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
- K051553 — FUJI SYNAPSE WORKSTATION SOFTWARE
- K051602 — AXIOM SIRESKOP SD
- K051624 — T2 RECON NAIL SYSTEM
- K051717 — RN SYNOCTA TEMPORARY MESO ABUTMENT
- K042522 — JAUNDICE METER, MODEL JM 103
- K042725 — QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
- K043238 — COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES
- K050231 — ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
- K051024 — EXPEDIUM SPINE SYSTEM
- K051110 — 1,25-DIHYDROXY VITAMIN D EIA
- K051185 — ELECSYS CA 19-9 CALCHECK
- K051268 — RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT
- K051486 — NORWOOD ABBEY CENTURION SES EPIKERATOME
- K051498 — DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR
- K050841 — FRAXEL SR LASER SYSTEM
- K051191 — DCL MICROALBUMIN ASSAY, MODEL 252-20
- K051266 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML
- K051517 — ELECSYS PRECICONTROL ANEMIA
- K041008 — EYE-CEPT REWETTING DROPS
- K041653 — COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS
- K042791 — INSTANT-X, MODELS 1713 & 128
- K042875 — NAVIGATOR
- K043353 — OMEGA EXCEL/XP LASER SYSTEM
- K050018 — TESLAOXYSAT, MODEL EFOXYSATE
- K050653 — TRANSEAR BONE CONDUCTION HEARING AID
- K050940 — PMP4 MEDICAL WEB CENTER
- K051106 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS
- K051136 — SMITH & NEPHEW CDS SYSTEM
- K051184 — 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K051255 — LUMIPHASE-R
- K051418 — DIRECT DIGITIZER REGIUS MODEL 370
- K051423 — MICK HDR INTERSTITIAL IMPLANT ACCESSORIES
- K051474 — SYMBIOS DISPOSABLE INFUSION PUMP KIT
- K051541 — GF-UE160-AL5 ULTRASOUND ENDOSCOPE
- K041496 — PENTATRASFU BLOOD TRANSFUSION SETS
- K043479 — MC+ PARTIAL VBR
- K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
- K050283 — CREATININE LIQUICOLOR
- K050803 — PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
- K051399 — WAVELIGHT AURIGA
- K051417 — 6 FR FL POWERHOHN AND POWERLINE CATHETER
- K051491 — TRABECULAR METAL PRIMARY HIP PROSTHESIS
- K051557 — TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS
- K042891 — DATEX-OHMEDA OXY-AFR SENSOR
- K043349 — OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
- K050441 — TAPER 2 POROUS FEMORAL STEM
- K050799 — TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS
- K050802 — MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
- K050845 — MONOCRYL PLUS ANTIBACTERIAL SUTURE
- K050858 — ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
- K050928 — DADE THROMBIN REAGENT
- K050953 — AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
- K051017 — R-X-FIX EXTERNAL FIXATOR
- K051027 — STALIF TT
- K051050 — SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092
- K051054 — VISULIZE FACTOR IX ANTIGEN KIT
- K051069 — NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER
- K051168 — BARRX HALO 360 SYSTEM, MODEL 1100C-115A
- K051219 — PUSHLOCK
- K051392 — BTI-SCAN, VERSION 4.0
- K051408 — INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS
- K051411 — ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
- K051448 — MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
- K051471 — CARDIODAY
- K051481 — JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP
- K051482 — JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP
- K051554 — ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
- K051608 — STAR 50 MONITORING SYSTEM
- K051630 — SUPER VIEW DISPOSABLE BIOM LENS SET
- K050178 — HBA1C ENZYMATIC ASSAY
- K050728 — OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
- K050954 — MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
- K050967 — VARELISA RECOMBI CTD SCREEN, MODEL 13096
- K051037 — IMAGEQUBE PACS
- K051059 — AMSURE 100% SILICONE FOLEY CATHETER
- K051512 — CAC-127-8 CARDOAC ARRAY COIL
- K051521 — REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION
- K051535 — MODIFICATION TO:REGISTRADO X-TRA
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