FDA 510(k) clearances — page 837
clearances on record, most recent first.
Clearances — page 837
83,601–83,700 of 176,637- K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX
- K001024 — PASS SPINAL SYSTEM
- K001029 — GEIGER NEEDLE ADAPTER, MODEL 406
- K001035 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
- K001041 — AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD
- K001042 — COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE
- K001049 — GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)
- K001065 — DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
- K001122 — PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
- K001128 — NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
- K001155 — DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
- K001190 — POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE
- K001307 — CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
- K001319 — XIA SPINE SYSTEM HOOKS
- K001327 — POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)
- K001358 — EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM
- K990614 — HME-BOOSTER
- K993921 — NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001
- K994098 — VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
- K994350 — NEER III TOTAL SHOULDER SYSTEM
- K994426 — GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)
- K000596 — ETEST GATIFLOXACIN
- K000879 — THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K000880 — THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K000930 — GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K000999 — MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K993131 — NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
- K993319 — VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
- K993586 — SPORTSIGHT GP
- K000133 — MENICON Z
- K000233 — MENICON SF-P
- K000308 — WALLSTENT BILIARY ENDOPROSTHESIS
- K000637 — CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
- K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
- K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
- K000729 — ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
- K000849 — SOFTFORM FACIAL IMPLANT
- K000894 — C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO
- K001043 — KAWASUMI LABORATORY BLOOD DRAWING KIT
- K001089 — POLYMACON
- K001090 — METHAFILCON A
- K001119 — ROVERS ENDOCERVEX-BRUSH
- K001221 — MALE LATEX COMDOM WITH DOTTED SURFACE
- K993758 — PROAIR 3000 COMPRESSION SYSTEM
- K994188 — MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
- K000298 — ETEST MOXIFLOXACIN
- K000611 — STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER
- K000779 — APEXPRO TELEMETRY SYSTEM
- K000784 — THE CARDIAC READER SYSTEM
- K000903 — ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
- K000921 — BAYER ADVIA IMS SYSTEM; 200 + 3
- K001086 — FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
- K001098 — PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
- K001237 — EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
- K001257 — INTRACOIL STENT
- K001335 — ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
- K001451 — MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
- K992320 — MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
- K992543 — HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
- K993438 — METAL ON METAL ACETABULAR SYSTEM
- K994225 — PALOMAR SLP 2000
- K000121 — IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
- K000155 — ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
- K000405 — INTERCURE LTD. RESPI-LOW
- K000530 — BELLEGLASS HP ENAMEL
- K000556 — ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS
- K000563 — MODIFICATION TO ENVOY PATIENT MONITOR
- K000597 — VITA RESPONSE
- K000618 — SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
- K000690 — 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
- K000775 — HEART 2005
- K000799 — BELMONT UNIT, MODEL 2000 SERIES
- K000812 — NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
- K000932 — ARACHNOPHLEBECTOMY NEEDLE
- K001115 — ULTRA CATHETER SET
- K001222 — OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
- K001224 — RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
- K001225 — ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
- K001260 — ALLROUND 55 LF
- K001308 — MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW
- K001333 — AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI
- K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM
- K001348 — ST/AR ST AND ARRHYTHMIA SOFTWARE
- K001381 — CIDEX OPA SOLUTION
- K001431 — MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
- K991348 — IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
- K993278 — AMBU NEONATE SILICONE RESUSCITATOR
- K993592 — AXIOM MULTIPURPOSE WOUND DRAIN
- K000303 — HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB
- K000520 — C-IT
- K000621 — SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
- K000623 — SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
- K000693 — UMECO OPTIMA MULTILINE LASER SYSTEM
- K000770 — PROVIEW MEDICAL IMAGE DISPLAY MODULE
- K001013 — MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
- K001169 — OPTIVU HDVD SYSTEM
- K001220 — ENDOPATH SURESEAL REDUCER CAP
- K001321 — ALL-PRO 2010
- K001438 — SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
- K993337 — APOLLO MULTI-RACIAL REFERENCE POPULATION
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