FDA 510(k) clearances — page 803
clearances on record, most recent first.
Clearances — page 803
80,201–80,300 of 176,637- K010186 — WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
- K010791 — REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
- K010802 — CARDIAC VIEW, MODEL 2001
- K010887 — INSULIN PEN NEEDLE ADAPTER
- K010966 — MEDLEY SP02 MODULE, MODEL 8220
- K011132 — AIRLIFE HEPA FILTER
- K011159 — ONE-STEP PLUS
- K011417 — ULTRASOUND SCANNER, TYPE 2102
- K011465 — SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
- K011494 — LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL
- K011516 — INFANT FLOW SYSTEM, MODEL M672P
- K011545 — VERDICT -II TCA, VERDICT-II MTD
- K011578 — M2376A DEVICELINK SYSTEM, MODEL M2376A
- K011601 — ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX
- K011609 — LIVESURE AMPHETAMINE SCREEN TEST
- K011610 — LIVESURE METHAMPHETAMINE SCREEN TESTS
- K011611 — CARDIOCAM MODEL 9CSY0799
- K011617 — LIFEJET PRINTER 400
- K011624 — EXPEDIO 500D R&F X-RAY SYSTEM
- K002911 — XSCAN32 TELERADIOLOGY SOFTWARE
- K010455 — ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
- K010724 — SOLA 700,SOLA 500, SOLA 300
- K010799 — COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
- K010862 — ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER
- K010875 — HYCARE LATEX EXAMINATION GLOVE, POWDERED
- K010885 — UNI-LASER 470
- K011001 — TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
- K011033 — DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
- K011071 — PARADIGM QUICK-SET INFUSION SET
- K011364 — CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
- K011370 — NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG
- K011371 — NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW
- K011377 — NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
- K001917 — PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
- K002410 — FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
- K002846 — HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
- K003035 — CLARREN HELMET
- K003062 — BACTEC MGIT 960 SIR KITS
- K003517 — OTRES TOOTHBRUSH SANITIZER MODEL TB100W
- K003570 — BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
- K003596 — SMITH & NEPHEW RESTIM
- K003937 — CPR EZY MASK AND PAD
- K003983 — STIMUPLEX HNS-11
- K010083 — TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
- K010108 — USS-LINE EXTENSION
- K010193 — HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
- K010471 — AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
- K010473 — SPARROWHAWK DISPOSABLE
- K010545 — TBW
- K010697 — UNIQUE AMBULATORY EEG
- K010856 — STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED
- K010866 — TEMP-A-SURE
- K010903 — TRI-FIX SPINAL FIXATION SYSTEM
- K010922 — TRI-FIX SPINAL FIXATION SYSTEM
- K010953 — CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
- K010963 — STA-LIATEST FREE PROTEIN S TEST KIT
- K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
- K011057 — INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
- K011082 — TPO IGG ANTIBODY EIA TEST
- K011390 — BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
- K011437 — SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
- K011466 — QED DIODE DETECTORS, MODELS 1112-1116
- K011485 — PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
- K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
- K003543 — STRYKER PAINPUMP PCA
- K010429 — ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
- K010682 — HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
- K010701 — MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
- K010824 — PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
- K011029 — MODIFICATION TO TSRH SPINAL SYSTEM
- K011179 — DELDENT ULTRASONIC INSERTS
- K011413 — POWDER-FREE VINYL EXAM GLOVE, YELLOW
- K011414 — POWDERED VINAL EXAM GLOVES
- K011425 — CARMEN
- K011428 — TRICERAM
- K011442 — ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
- K011563 — POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM
- K011580 — SIMPLICITY SOFT QD SILVER INFUSION SET
- K003472 — INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
- K003538 — TDP CQ-27 HEAT LAMP
- K010122 — CONTINUOUS FLOW Y-TUBING
- K010658 — MODIFIED USS FRACTURE SYSTEM
- K010667 — GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
- K010669 — NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1
- K002405 — SPINAL EPIDURAL NEEDLES
- K003741 — JET SYRINGE MODEL-100500
- K003973 — RESPIRATORY HUMIDIFIER, MODEL HC150
- K003992 — PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
- K010009 — KOKO PEAK KP; KOKO PEAK KP+
- K010226 — VERDICT -II METHAMPHETAMINE
- K010315 — ISCREEN VISION SCREENER
- K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- K011366 — CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
- K011587 — SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
- K001442 — ESU HANDSWITCHING PENCIL
- K002514 — CADHEALTH SYSTEM, MODEL CHP-001
- K002847 — INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
- K003761 — NAT - NUCLEIC ACID TRANSPORT
- K003871 — LAPAROSCOPIC HAND PORT
- K010632 — BUTTERFLY PLATE FUNCTION SYSTEM
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