FDA 510(k) clearances — page 629
clearances on record, most recent first.
Clearances — page 629
62,801–62,900 of 176,637- K061562 — VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
- K061772 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM
- K061788 — BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
- K061791 — FOCUS VNG/ENG TYPE 1068
- K053554 — COMPUFLO
- K060788 — TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
- K061055 — CAREO SAFETY SYRINGE FOR U-100 INSULIN
- K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS
- K061267 — SIMULATE, COLOR CHANGE ALGINATE
- K061366 — DENLASER 800 PLUS
- K061511 — R&D CBC-3D + CRP HEMATOLOGY CONTROL
- K061655 — DIMENSION VISTA FLEX REAGENT CARTRIDGES
- K061667 — CELL-DYN RUBY SYSTEM
- K061677 — SOLAR PUREFIX HA SHOULDER
- K061702 — DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
- K061771 — EZ-CONNECT
- K052458 — LIV MEDICA CPR FACE MASK
- K053468 — NESS L300
- K060289 — EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
- K060363 — HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
- K060785 — POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR
- K060902 — STARCLOSE INTRODUCER SET MODEL- 1002
- K060942 — WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
- K061310 — ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM
- K061321 — ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
- K061329 — INFINITY MASIMO SET SP02 POD
- K061493 — APEX PINS
- K061534 — ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
- K061654 — TRIDENT CONSTRAINED ACETABULAR INSERT
- K061800 — CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER
- K053213 — BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM
- K053593 — PRODIGY
- K060448 — LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
- K060569 — BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
- K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
- K061137 — ADVIA IMS CPSA CONTROL
- K061139 — BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
- K061150 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
- K061164 — ACTIVAPIN
- K061181 — ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
- K061338 — DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
- K061382 — ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
- K061481 — GRENGLOO
- K061498 — ALLOFIX ANCHOR, 5.0 MM ANCHOR
- K061569 — SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
- K061693 — FORYOU POWERED WHEELCHAIR, MODEL FC-100
- K052354 — OCULASE MD
- K053406 — BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
- K060970 — AXYALOOP NONABSORBABLE BONE ANCHOR
- K061262 — LIGAFIX INTERFERENCE SCREW
- K061386 — ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB
- K061390 — DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
- K061474 — COLLAWOUND DRESSING
- K061540 — LEKSELL GAMMAPLAN
- K061694 — MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S
- K051704 — MYKRES SPINAL SYSTEM
- K053336 — STAXX FX SYSTEM
- K060480 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
- K060494 — EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
- K060809 — OSTEO-LINK BONE VOID FILLER PELLETS
- K061060 — TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8
- K061093 — CHOLINESTERASE GEN.2 TEST SYSTEM
- K061116 — MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR
- K061156 — ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
- K061222 — INJECTRA INJECTION NEEDLE
- K061284 — I-CAT SCANNER
- K061292 — STATARIUS, MODEL 001 003
- K061327 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0.
- K061333 — URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
- K061356 — POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6
- K061525 — GE VIVID - I
- K061547 — DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER
- K061570 — I-STYLE BONE MARROW ASPIRATION NEEDLE
- K061576 — MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
- K061592 — MODIFICATION TO CD HORIZON SYSTEM
- K061594 — LARGE UNI-CLIP STAPLE
- K061603 — SMOOTHSHAPES
- K061769 — E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
- K053372 — LBI CATHETER SYSTEM
- K053373 — ATLANTIS ABUTMENT FOR ZIMMER INTERFACE
- K053571 — MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
- K061003 — SFB & CFB IMPLANTS
- K061115 — SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216
- K061147 — OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
- K061197 — KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
- K061218 — DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
- K061271 — ERCH ARCH BAR, MODEL 38-690-00
- K061459 — TRANQUIL TRI-BTE
- K061488 — CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM
- K061538 — ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
- K061545 — SCENIUM 1.1
- K051278 — GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
- K051336 — GERATHERM SOS-RESCUE BAG
- K060616 — NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100
- K060666 — CAROTID ACCESS KIT
- K060759 — Y-CLICK CONNECTOR
- K060901 — VASHE WOUND CLEANSING SYSTEM
- K060908 — SONOHYSTEROGRAPHY BIOPSY DEVICE
- K061039 — AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
- K061400 — CALCANEAL TRAUMA SYSTEM
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