FDA 510(k) clearances — page 658
clearances on record, most recent first.
Clearances — page 658
65,701–65,800 of 176,637- K051908 — CHARLOTTE COMPRESSION PLATE
- K051955 — QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
- K052011 — PILONPLATE WITH ANGULAR STABILITY
- K040428 — MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM
- K043224 — GEN-PROBE APTIMA COMBO 2 ASSAY
- K050182 — Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM
- K050216 — OMNILUX REVIVE AND OMNILUX PLUS
- K050446 — BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
- K051014 — SILENT PARTNER SERIES OSA APPLIANCES
- K051368 — BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM
- K051428 — VTRAC EXCIMER LAMP SYSTEM
- K051434 — COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV
- K051732 — ENDOSCOPIC APPLICATOR
- K051754 — ORTHOSCAN, ORTHOSCAN HD
- K051796 — CLEARFIL TRI-S BOND SINGLE DOSE
- K051802 — FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
- K051941 — CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
- K051967 — REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
- K052029 — SYNGO CIRCULATION
- K052042 — SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS
- K052053 — LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
- K052113 — DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K050655 — MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005
- K050657 — MONDEAL CONTOUR HO SYSTEM
- K050836 — CRP DIAGNOSTIC ASSAY
- K051121 — DIRECT LDL CHOLESTEROL, MODEL L530-60H
- K051193 — VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER
- K051199 — IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
- K051200 — HEMOGLOBIN A1C REAGENT SET
- K051409 — SLIVASURE
- K051808 — ESTELITE FLOW QUICK
- K051917 — DIVER C.E. CATHETER
- K051936 — CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS
- K040627 — DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
- K043388 — PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
- K043547 — COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM
- K051042 — METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000
- K051231 — VERIFYNOW-P2Y12 ASSAY
- K051322 — PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
- K051385 — EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
- K051503 — UGYTEX SUAL KNIT MESH
- K051539 — TRICOT BLOOD PRESSURE CUFF
- K051570 — AVL HINGE KNEE SYSTEM
- K051689 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML
- K051846 — 7F SHERPA NX GUIDE CATHETER
- K051854 — CLEVER CHEK TD-4225, MODEL TD-4225
- K051883 — DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
- K051884 — CHARLOTTE SMALL MTP FUSION PLATE
- K051916 — POLAR CATH PERIPHERAL DILATATION SYSTEM
- K051949 — 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
- K051983 — MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
- K051989 — GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE
- K052037 — MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
- K052051 — OMNI SPHINCTEROTOME
- K052090 — SPLASH! IMPRESSION MATERIAL DEVICE
- K043034 — OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
- K050430 — MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR
- K050465 — IMMUNALYSIS COCAINE ELISA FOR HAIR
- K051362 — INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000
- K051468 — INNER-LOCK INTRODUCER SHEATH
- K051496 — COBALT BONE CEMENT
- K051529 — AMBU NEUROLINE GROUND
- K051586 — VIEWSEND MEDICAL SYSTEM
- K051601 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K051609 — QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
- K051660 — DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
- K051814 — JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
- K051890 — ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
- K051971 — OPTIMA SPINAL SYSTEM
- K030146 — KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+
- K050994 — AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
- K051327 — ABBOTT AXSYM B12
- K051378 — POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K051437 — CML 1000
- K051485 — AMS PELVIC FLOOR REPAIR SYSTEM
- K051532 — COBALT G HV BONE CEMENT
- K051818 — BEAUTIFIL FLOW
- K051851 — AVISO OPHTHALMIC ULTRASOUND SYSTEM
- K052006 — POWDER-FREE VINYL EXAM GLOVES
- K042394 — DIAGNODENT PERIO TIP (ACCESSORY)
- K051045 — SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30
- K051285 — GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
- K051426 — CARLO SURGICAL GOWN
- K051618 — SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64
- K051639 — AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM
- K051649 — VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0
- K051715 — STARPACS DENTAL
- K051855 — VENTRI
- K051935 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
- K052013 — ACHIEVA 1.5T & INERA 1.5T FAMILY
- K050927 — RT019 INSPIRATORY/EXPIRATORY FILTER
- K051122 — ITAG MHC TETRAMER CMV ASSAY
- K051406 — OSTEOCURE RESORBABLE BEAD KIT
- K051619 — LIPOPROTEIN FOR MULTIPLE ANALYTES
- K051683 — POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
- K051939 — MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
- K041893 — INTRALASE FS LASER
- K042562 — LENS PLUS REWETTING DROPS
- K043573 — DYNAGRAFT II DENTAL
- K051287 — VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
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