FDA 510(k) clearances — page 847
clearances on record, most recent first.
Clearances — page 847
84,601–84,700 of 175,890- K993475 — AUROFLUID M, ALLOY NO. 5315
- K993631 — QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
- K993821 — VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
- K993829 — ACCU-CHEK SIMPLICITY SYSTEM
- K991882 — NEXFLEX TOTAL KNEE SYSTEM
- K992595 — HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH
- K993505 — V-DELTA SPECIAL, ALLOY NO. 5154
- K993506 — PAGALINOR 4 , ALLOY NO. 5440
- K993766 — HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
- K984168 — BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
- K990329 — PHILIPS EASYVISION WORKSTATION
- K990643 — PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
- K991706 — VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
- K993299 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
- K993774 — ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
- K993945 — BIONIKE AQ PHENCYCLIDINE (PCP) TEST
- K984088 — OPTISTAR MR INJECTOR SYSTEM
- K990110 — DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
- K990111 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
- K990112 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
- K990113 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
- K990115 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
- K991339 — TYRODE'S SOLUTION-ACIDIFIED
- K992188 — NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028
- K992711 — SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
- K992712 — SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
- K992759 — COLON ALERT TEST
- K993008 — QUANTITATIVE SENTINEL SYSTEM
- K993073 — SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030
- K993255 — BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE
- K993304 — AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
- K993309 — BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
- K993314 — SYNTHES LIGHT GUIDE
- K993353 — TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
- K993435 — MANUAL BONE MARROW BIOPSY DEVICE
- K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR
- K993482 — K-ASSAY FIBRINOGEN
- K993507 — V-SUPRAGOLD, ALLOY NO. 5024
- K993508 — V-SUPRA PLUS, ALLOY NO. 5025
- K993566 — PROMPTFLOW
- K993688 — AED LAPAROSCOPE
- K993808 — SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220
- K993854 — ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
- K993907 — VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22
- K981655 — SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
- K990807 — HL148 & HL168
- K991575 — PRIMUS STEAM STERILIZERS
- K992992 — AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
- K993001 — COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
- K993454 — POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)
- K993708 — BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
- K993729 — MODIFICATION TO CARTO EP NAVIGATION SYSTEM
- K993749 — GYRUS HYSTEROSCOPIC RESECTOSCOPE
- K993752 — GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K993776 — OBC-300 BREAST ARRAY COIL
- K993819 — QWH-300 WRIST ARRAY COIL
- K993860 — CATHETER INNOVATIONS IMPLANTABLE PORT
- K984564 — ETHYL CHLORIDE DISPENSER
- K991492 — LC COMPOSITE
- K991656 — AED ARTHROSCOPE
- K992479 — ENSITE 3000 SYSTEM
- K993043 — MS-30 FEMORAL STEM
- K993102 — DRIED GRAM-POSITIVE MIC/COMBO PANELS
- K993104 — STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
- K993127 — MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
- K993214 — DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS)
- K993215 — DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE
- K993261 — TALON ANCHOR SNAP-PAK
- K993271 — QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS
- K993457 — POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS]
- K993474 — DELTAPAL, ALLOY NO. 5161
- K993500 — POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)
- K993634 — CARESIDE ANALYZER
- K993692 — DURACON INSET PATELLA, 25MM
- K993703 — CLEARVIEW EASY HCG PREGNANCY TEST
- K993820 — POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS
- K993944 — RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE
- K974503 — ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K990398 — PLATELETWORKS
- K992384 — CPAP/PRO CPAP INTERFACE
- K992977 — HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
- K993135 — IMPLANTABLE CLIP FOR GENERAL SURGERY
- K993203 — ACON ONE STEP PREGNANCY TEST STRIP (URINE)
- K993317 — ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
- K993388 — ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F
- K993569 — APR METASUL ACETABULAR INSERT
- K993577 — CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC
- K993890 — DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181
- K992233 — APEX LOCATOR BINGO-1020
- K992255 — CKHEMO, MODEL CKHEMO VERSION 1.0
- K993310 — APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
- K993323 — K-ASSAY IGM
- K993496 — RETIC-QUINOX
- K993537 — K-ASSAY TRANSFERRIN
- K993546 — TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3
- K993642 — ELECSYS PARATHYROID HORMONE CALCHECK
- K993825 — PARA TECH PLUS RETICS
- K981485 — HYBRID CAPTURE II GC-ID
- K992862 — SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K992948 — MAC-LAB SYSTEM
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