FDA 510(k) clearances — page 855
clearances on record, most recent first.
Clearances — page 855
85,401–85,500 of 176,637- 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
- K993013 — SURE BOND
- K993249 — OPC LOW WEAR OPAQUE PORCELAIN
- K993481 — K-ASSAY C4
- K993721 — UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
- K993646 — S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K981914 — TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
- K990659 — NASAL AIRE
- K990727 — SYNEFLASH & SYNEVIEW
- K990808 — PBN DILATORS
- K991105 — ECG ELECTRODE (VARIOUS)
- K991850 — SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
- K992665 — MACRA LP(A) ENZYME IMMUNOASSAY KIT
- K992842 — HICHEM ISE ELECTROLYTE REFERENCE
- K992844 — HICHEM ISE ELECTROLYTE BUFFER
- K992929 — DASH 3000 PATIENT MONITOR
- K992965 — CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
- K993014 — MODIFICATION TO DOCUMENT THYROID CAL.VER
- K993023 — SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
- K993126 — CD-CHEX CD 34
- K993425 — PRIMUS
- K993473 — SYNCHRON SYSTEMS DRUG CALIBRATOR 2
- K993589 — VARELISA RNP ANTIBODIES
- K993606 — K-ASSAY APO A1/B CALIBRATOR SET
- K993719 — KAC-300 KNEE ARRAY COIL
- K993728 — MEDRAD ENVISION CT INJECTOR SYSTEM
- K993740 — MAMEX
- K993763 — QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
- K993765 — QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
- K993780 — QSC-300 SHOULDER ARRAY COILS
- K981786 — IGA MININEPH ANTISERUM
- K991417 — ABL 735 ANALYZER
- K992257 — NEW MULTIPLES REAGENT STRIPS
- K992264 — OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
- K992449 — AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
- K992682 — MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
- K992683 — MODUS 2.5 MANDIBULAR TRAUMA SET
- K992710 — ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
- K992834 — GEM PREMIER 3000
- K992872 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
- K992894 — MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
- K992900 — PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
- K992909 — HYTAC
- K992996 — ENABLE ENDOSCOPIC BIPOLAR SCISSORS
- K993071 — PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
- K993252 — METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP
- K993360 — PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
- K993437 — K-ASSAY C3
- K993441 — K-ASSAY ALPHA-1 AG
- K993444 — K-ASSAY ALPHA-1 AT
- K993480 — K-ASSAY HAPTOGLOBIN
- K993495 — POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)
- K993502 — POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)
- K993617 — DIGITRAKPLUS HOLTER RECORDER
Data sourced from openFDA. This site is unofficial and independent of the FDA.