FDA 510(k) clearances — page 823
clearances on record, most recent first.
Clearances — page 823
82,201–82,300 of 175,890- K001721 — PASCO MIC AND MIC/ID PANELS
- K001724 — STIMULAN -CALCIUM SULFATE BONE VOID FILTER
- K001803 — ACCELERATOR RECIPROCATING CANNULA
- K001808 — DORO HEADREST SYSTEM
- K001913 — CLEARFIL ST OPAQUER
- K001975 — CERALAS D10 810NM LASER, MODEL CERALAS D10-60
- K001994 — EEI SLUSH PAN DRAPE
- K002107 — IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
- K002170 — MODEL 9000 PEDIATRIC WHEELCHAIR
- K983299 — ALLEGIANCE GENESIS CONTAINER SYSTEM
- K991522 — MICROTARGETING ELECTRODE
- K991971 — ARTHREX CHONDRAL DART, MODEL AR-4005B-18
- K992133 — NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
- K992226 — XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
- K993166 — STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
- K993788 — R.TEST EVOLUTION
- K994399 — INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
- K994400 — INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
- K001553 — BREAS PV 100 CPAP SYSTEM
- K001641 — TAMPONS
- K001878 — WATER PURIFIER
- K002053 — NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
- K002212 — MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
- K993052 — VYGON 2 FR EPICUTANEO PUR-CATHETER
- K993442 — VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)
- K994109 — DETRUSAN 500
- K994155 — EXCELSIOR 1018 MICROCATHETER
- K001077 — LUBRIGEL PERSONAL LUBRICANT
- K001409 — GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
- K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
- K001590 — DND 101
- K001662 — CHASE CARDIOVASCULAR PATCH
- K001736 — GALEO HYDRO AND GALEO HYDRO J-TIP
- K001825 — STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER
- K001928 — SIGMA
- K002009 — HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
- K990100 — POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
- K993140 — WATER FOR TISSUE CULTURE, MODELS 1500
- K000204 — WIN-1 TANGO
- K000737 — COAXIAL DILATOR SET
- K001182 — MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1
- K001400 — ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM
- K001410 — PHORESOR MODEL PM2000
- K001467 — DA VINCHI EMG/EP ISA1004EP
- K001496 — A.V. FISTULA NEEDLE
- K002085 — ULTRASOUND SCANNER, TYPE 1101
- K002185 — SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
- K990517 — EXPLORER CVS TRANSCRANIAL DOPPLER
- K992905 — CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
- K993524 — ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS
- K001515 — PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
- K001533 — SURGIFLATOR-40
- K001539 — RENU MULTIPLUS MULTI-PURPOSE SOLUTION
- K001690 — PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
- K001798 — DC TITAN
- K001883 — LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
- K002101 — ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
- K002175 — NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
- K002176 — NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE
- K002323 — ADVANCED UROSCIENCE INJECTION NEEDLE
- K001378 — BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
- K001388 — DATA MASTER PERFUSION MONITORING SYSTEM
- K001873 — HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
- K002211 — COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
- K994161 — SYNTHES BIORESORBABLE SUTURE ANCHOR
- K000050 — TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
- K001349 — CARDIOVISE ECG INTERPRETATIVE SOFTWARE
- K001372 — E-Z LINK CROSS CONNECTOR
- K001374 — PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
- K001385 — HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
- K001419 — SOLAR SHOULDER OFFSET HUMERAL HEAD
- K001527 — FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
- K001536 — INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
- K001616 — MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
- K001728 — HARDY DISK CLARITHROMYCIN, 15MCG
- K001739 — POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P
- K001745 — MODIFICATION TO PROVIDENT HIP SYSTEM
- K001748 — MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K001753 — MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K002049 — INVERNESS MEDICAL EARLY PREGNANCY TEST
- K002106 — NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
- K002192 — DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38
- K990119 — EPI-STAR SURGICAL LASER SYSTER
- K994398 — INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
- K000887 — DRX HBA1C
- K001092 — GENERIC BLOOD GLUCOSE TEST STRIP
- K001340 — STACKABLE CAGE SYSTEM
- K001350 — PATIENT MATCHED TITANIUM ALLOY TROCHLEA
- K001369 — RESPIEVENTS, VERSION 4.2
- K001445 — SMILIE PC
- K001466 — VOCOM SILICONE SYSTEM
- K001497 — MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
- K001619 — MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)
- K001836 — NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
- K001950 — OPTICAL TRACKING SYSTEM (OTS)
- K001959 — POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K001982 — TRI-LOCK HIP STEM
- K002033 — BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
- K990365 — GASTRIC LAVAGE VALVE
- K001314 — MEDSCOPE
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