FDA 510(k) clearances — page 586
clearances on record, most recent first.
Clearances — page 586
58,501–58,600 of 176,637- K073170 — R-PORT II LAPAROSCOPIC ACCESS DEVICE
- K070015 — COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
- K070705 — MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
- K070900 — FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
- K071202 — DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
- K071265 — SMARTCHECK INR SYSTEM
- K071667 — SYNTHES VECTRA-ONE SYSTEM
- K072115 — ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
- K072325 — BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
- K072783 — SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH
- K073017 — STRYKER STRI-SHIELD FLYTE TOGAS
- K073100 — INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
- K073236 — NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE
- K071385 — STERRAD 100NX STERILIZER
- K072049 — CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS
- K072194 — RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
- K072346 — PM-7000 PATIENT MONITOR
- K072383 — HABIB ENDOBLATE
- K072446 — MOBIL-O-GRAPH NG 24 H ABP-CONTROL
- K072449 — CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
- K072463 — SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM
- K072482 — HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
- K072520 — TEPHAFLEX SURGICAL FILM
- K072843 — YG-125T AND YG-135T NASAL ADAPTER
- K072982 — PARI HYDRATE V
- K073060 — CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K073203 — CARESCAPE V100
- K073323 — SA-3000P
- K062931 — IMPLUS IMPLANT SYSTEM
- K063245 — ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
- K071815 — NOVEON, MODEL LS1100-01-0968
- K072578 — SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
- K072650 — IST ANTERIOR CERVICAL PLATE SYSTEM
- K072672 — SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
- K072922 — 3S HEMI TOE
- K073182 — GYN DISPOSABLES TENACULUM 356T
- K071624 — EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR
- K072260 — NUFACE, MODEL NU-4003
- K072795 — MODELS EMS 5.0, EMS 5.1
- K073054 — MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER
- K073102 — BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
- K062575 — MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
- K062658 — PRIMUS A1CARE ASSAY
- K070513 — HAMILTON-G5
- K071588 — DISPENSER DP 20
- K072509 — PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY
- K072780 — MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
- K072822 — FUNHALER, MODEL V-201E
- K072827 — RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
- K072846 — CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
- K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
- K071228 — FIDELITY 200 CARDIAC EVENT RECORDER
- K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
- K071521 — TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
- K071641 — REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)
- K071655 — REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
- K071927 — MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
- K071958 — THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
- K072372 — PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE
- K072398 — RT300-S AND RT300-SP FES CYCLE ERGOMETER
- K072480 — GENERATION 8 SE ADHESIVE
- K072618 — TWIN-PASS OTW CATHETER, MODEL 5201
- K072619 — NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS
- K072807 — I LIGHT
- K072850 — MRI SYSTEM, MODEL MAGFINDER II / AI 3200
- K072867 — IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K
- K073013 — CTU676 DEVICE
- K073081 — JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
- K073108 — ZENO ZR DISC
- K073122 — MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE
- K073140 — VITALOGIK MODEL 4000/4500
- K073146 — PADNET+
- K073181 — NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL
- K070228 — IMPLANTIUM PROSTHETICS
- K070691 — BBL CHROMAGAR 0157
- K071579 — PEF TUBE
- K071729 — CELLSEARCH CIRCULATING TUMOR CELL KIT
- K071967 — SYSMEX XE-5000
- K072133 — AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
- K072268 — HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
- K072286 — BIS EEG VISTA MONITOR SYSTEM AND BISX
- K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
- K072556 — HEMOSTASIS VALVE
- K072661 — IMMUNOCAP THYRLOBULIN IMMUNOCAP
- K072858 — TC-PLUS PRIMARY KNEE SYSTEM
- K072986 — INTEGRADWEB PACS SYSTEM
- K073035 — PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
- K073099 — FMRI HARDWARE SYSTEM
- K063050 — CAP PLUS
- K071371 — COPA AMD ANTIMICROBIAL WOUND DRESSING
- K071535 — BIOLOX DELTA CERAMIC FEMORAL HEAD
- K072022 — VALEO PEDICLE SCREW SPINAL SYSTEM
- K072030 — IMPLANT CENTER
- K072101 — RIGI-FIX HIP STEM SYSTEM
- K072202 — CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)
- K072309 — MICROLUX/BLU
- K072391 — PFM PICC
- K072502 — MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
- K072639 — YUYUAN LATEX EXAMINATION GLOVE, POWDERED
- K072740 — MONDEAL EXTREMITY BONE FIXATION SYSTEM
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