FDA 510(k) clearances — page 809
clearances on record, most recent first.
Clearances — page 809
80,801–80,900 of 176,637- K010671 — POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
- K010830 — POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
- K010909 — NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
- K010931 — AMS SACRAL COLPOPEXY SLING, MODEL 72403501
- K002726 — TCOYF FERTILITY SOFTWARE VERSION 1.0
- K002889 — PNS MAGNETIC STIMULATOR SYSTEM
- K003274 — LPC-PLUS ACETABULAR CUP
- K003542 — PREAMP CABLE, MODEL B400-1011PA
- K010100 — AVON PATELLO-FEMORAL JOINT PROSTHESIS
- K010124 — ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
- K010171 — DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
- K010776 — TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS
- K010801 — T2 FEMORAL NAIL
- K010883 — TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
- K010924 — MODIFICATION TO PLUM XL INFUSION PUMP
- K002617 — PERIFORM PERINEOMETRIC PROBE, MODEL 8300
- K002892 — FRSENIUS PD IQCARD CYCLER
- K003350 — HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)
- K003701 — SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)
- K010046 — NUVOLASE 532 MEDICAL LASER SYSTEM
- K010129 — EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
- K010133 — VERSALUX
- K010196 — TOTAL CURE
- K010199 — PJUR EROS WATER FORMULATION
- K010236 — IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
- K010377 — MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
- K010561 — VERDICT -II BAR/BZO
- K010564 — VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO
- K010593 — SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
- K010623 — RECONSTITUTION KIT & VIAL CONNECTOR
- K010653 — AT HOME DRUG TEST, MODEL 9068 T
- K010654 — AT HOME DRUG TEST, MODEL 9078 T
- K010655 — AT HOME DRUG TESTT, MODEL 9150 T
- K010664 — COPELAND RESURFACING HUMERAL HEADS
- K010829 — POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
- K010859 — THE LIBERATOR WHEELCHAIR
- K010900 — STS-T LITHOTRIPTER, MODEL STS-T
- K010906 — MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
- K010912 — ALARMVIEW WIRELESS DATA NETWORK SYSTEM
- K003272 — FLO-BOOT
- K003417 — MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET
- K010035 — IVS TUNNELLER
- K010117 — GUIDANT AXIUS CORONARY SHUNT
- K010737 — SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924
- K994083 — STANNAH POWER CHAIR, MODEL 201
- K001892 — WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
- K003613 — 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
- K003986 — ULTRASOUND SCANNER TYPE 2102
- K010074 — MODEL 455GE PHASED ARRAY WRIST COIL
- K010110 — POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
- K010271 — THINKINGNET
- K010461 — ADVIA RETIC PLUS
- K010558 — QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
- K010792 — MAMMOGRAPH
- K010860 — LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
- K010861 — LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
- K001893 — WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
- K001997 — WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
- K002856 — AT3C70 TRANSDUCER
- K010005 — CYNOSURE PHOTOGENICA DL
- K010010 — VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR
- K010063 — COUCH FOR TOTAL BODY RADIATION
- K010092 — XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
- K010112 — BIPOLAR COAGULATION SYSTEM
- K010192 — ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION
- K010412 — FLEXIBLE ENDOSCOPIC SCISSORS
- K010685 — MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)
- K010762 — PHILIPS BV LIBRA
- K001398 — REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
- K002019 — RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
- K003382 — SARSTEDT NEEDLE PROTECTOR
- K003794 — ELISA TEST, SEROLOGY
- K010028 — SHEER THIN AROMAS RED LATEX CONDOM
- K010097 — POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K010538 — PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E
- K010641 — GE CT-PET SYSTEM
- K010645 — AT HOME DRUG TEST, MODEL 9063 T
- K010646 — AT HOME DRUG TEST, MODEL 9083 T
- K010650 — AT HOME DRUG TEST, MODEL 9073 T
- K010651 — AT HOME DRUG TEST, MODEL 9133 T
- K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
- K010663 — POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE
- K010721 — AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
- K994381 — PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
- K000814 — FINGER PULSE METER
- K003873 — MENTOR SELF-CATH CLOSED SYSTEM
- K004039 — CYNOSURE PHOTOGENICA NEO-V
- K004040 — REDTECH GIPC 2000
- K004051 — SHEER THIN AROMAS YELLOW LATEX CONDOM
- K010201 — BAYER ADVIA IMS SYSTEM
- K010263 — REMSTAR PLUS CPAP SYSTEM
- K010622 — PRESSURE TRAK, MODEL 222-B
- K010707 — ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
- K010828 — DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
- K002705 — EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
- K002901 — KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
- K004031 — NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES
- K010567 — OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
- K010571 — ADC QS/IPD WORKSTATION
- K010588 — ELECSYSCA 15-3 II ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.