FDA 510(k) clearances — page 766
clearances on record, most recent first.
Clearances — page 766
76,501–76,600 of 176,637- K021441 — RADIUS SNARE
- K021484 — HEMOGLOBIN A1C CONTROL
- K021586 — SECURE RELINE/PICKUP MATERIAL
- K021605 — MEDGEM
- K021866 — KARMA 800 SERIES MANUAL WHEELCHAIR
- K013022 — SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
- K020588 — X-IMAGE DIGITAL X-RAY SYSTEM
- K020603 — CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
- K020630 — ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER
- K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-100
- K020707 — EBV-EBNA IGG ELISA KIT, MODEL EBG-100
- K020717 — EBV V VCA IGM ELISA KIT MODEL# EBM-200
- K020753 — DEROYAL SURGICAL, UMBILICUP
- K020853 — NUVASIVE MESH
- K020856 — SPATOUCH PHOTOEPILATION SYSTEM
- K020957 — ORACAM
- K020966 — RPI REPLACEMENT HEATING ELEMENTS
- K020991 — SYNGO MR 2002B
- K021113 — MAMMOPATH
- K021393 — PRECISET DAT PLUS
- K021433 — MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
- K021593 — MODIFICATION TO ENVOY AND VISTA BRITE TIP
- K021632 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL
- K021656 — HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
- K021763 — RS2MI MUSCLE STIMULATOR FAMILY
- K012701 — ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
- K012969 — DOUBLE SPRINGERS NONOXNOL 9 CONDOM
- K014183 — AFB (ABSORBABLE FOAM BUTTRESS)
- K014273 — ACUSTIM
- K020827 — K-Y BRAND ULTRA GEL PERSONAL LUBRICANT
- K020834 — BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER
- K020835 — CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60
- K020872 — SYNTHES 3.5 MM BROAD LC-DCP PLATES
- K020874 — ULTRA-LITE 5 TURBO LIGHT CURE UNIT
- K020877 — EXCELLITE TURBO LIGHT CURE UNIT
- K020884 — EXCELLITE LIGHT CURE UNIT
- K021109 — ESOP CO-CR FEMORAL HEADS
- K021160 — DERMMATRIX SURGICAL MESH
- K021570 — HNC-127-TRIO NEUROVASCULAR ARRAY COIL
- K021575 — OBC-127 BREAST ARRAY COIL
- K021715 — CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
- K021755 — APEX MEDICAL DIGITAL TENS TS1211, TS1212
- K012512 — SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
- K013041 — PLEXOLONG SETS
- K013131 — BIOSCREW XTRALOK
- K013790 — CALCIGEN-S BONE VOID FILER
- K014211 — OXYARM CO2
- K020410 — MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML)
- K020836 — RABEA CEMENT RESTRICTOR
- K020866 — FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
- K020869 — FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)
- K021018 — MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
- K021150 — COULTER CELLPREP
- K021513 — ACCU-CHEK ADVANTAGE MODULE
- K021561 — DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O
- K021667 — DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
- K021673 — TOTAL HIP FEMORAL HEAD - 12/14 TAPER
- K010952 — SURGISIS GUIDED TISSUE REGENERATION MATRIX
- K014066 — LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
- K014067 — LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC
- K014069 — LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
- K020297 — STAT PROFILE CRITICAL CARE XPRESS ANALYZER
- K020800 — OPTAX SYSTEM
- K020803 — CEFAR MEDICAL AB CEFAR PRIMO
- K020880 — MARKNEW PRODUCTS ACUPUNCTURE NEEDLES
- K021006 — STARTOX DRUG OF ABUSE SCREENING TEST
- K021020 — TERUMO GAS FILTER
- K021381 — MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
- K021388 — CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM
- K021536 — DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR
- K021598 — ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE
- K021743 — (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
- K021833 — MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
- K021850 — SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS
- K012232 — INSIGHT, MODEL S980000
- K014088 — DUPLOREACH
- K020783 — TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
- K021372 — VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
- K021378 — PORTABLE HDX INTRAORAL X-RAY
- K021412 — LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
- K021427 — CLEARFIL SA PRIMER
- K021527 — SECTRA OSTEOPOROSIS PACKAGE
- K011866 — OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
- K013980 — SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES
- K020791 — HBS HEADLESS BONE SCREW
- K020830 — SCORPIO INSET PATELLAR COMPONENT
- K020850 — GPF-29 GENERAL PURPOSE COIL SET
- K020860 — M3 (MICRO-MULTILEAF COLLIMATOR)
- K020943 — STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE
- K020971 — DCM 2.0
- K021004 — VALVED PEELABLE INTRODUCER
- K021010 — MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
- K021021 — MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
- K021072 — FILMSAVER, NT VERSION 5.03
- K021078 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
- K021110 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
- K021111 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
- K021169 — MICROSTREP PLUS PANEL, AZITHROMYCIN
- K021188 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
- K021220 — NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Data sourced from openFDA. This site is unofficial and independent of the FDA.