FDA 510(k) clearances — page 894
clearances on record, most recent first.
Clearances — page 894
89,301–89,400 of 176,637- K982826 — MEGA 2000
- K982828 — FORTE, MODELS CPS 400 STIM, CPS 200 STIM
- K982829 — FORTE, MODEL CPS ULTRASOUND
- K982830 — FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
- K982837 — KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
- K982933 — VINYL EXAMINATION GLOVES, POWDER FREE
- K983025 — XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
- K983092 — TRITON HUDSON CHUCK ATTACHMENT
- K983141 — CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
- K983218 — N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
- K983280 — VANCOMYCIN EIA ASSAY
- K983283 — SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM
- K983367 — QLICKSMART
- K983405 — ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50
- K983407 — ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F
- K983520 — BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD
- K983538 — MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY
- K983581 — OCU-GUARD AND OCU-GUARD SUPPLE
- K983585 — LOW PH PHENOLIC 256
- K983632 — SIEMENS SC 8000 BEDSIDE MONITOR
- K983677 — QUICKIE G SERIES, MODEL G-424
- K983684 — DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS
- K980129 — INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS)
- K980756 — COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
- K981064 — POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
- K982166 — CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
- K982720 — H-RAY
- K982821 — MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7
- K983151 — IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
- K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
- K983287 — MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
- K983494 — VINYL EXAM GLOVES, POWDER FREE
- K983608 — EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK
- K983612 — POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES
- K971616 — BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)
- K973765 — BIO-2000
- K981556 — CANON X-RAY DIGITAL CAMERA CXDI-11
- K982639 — SPIFE URINE IFE
- K982760 — COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
- K982790 — QUANTA LITE H. PYLORI IGG ELISA
- K982801 — AUTO-LYTE PCP EIA, MODEL #1254U
- K982838 — CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
- K982855 — DIGIRAD 2020TC SPECT IMAGING SYSTEM
- K982857 — HELAX-IMCON, VERSION 1.0
- K982955 — SILHOUETTE VR
- K983083 — QUANTA LITE RF IGG ELISA
- K983084 — QUANTA LITE RF IGA ELISA
- K983132 — IGM
- K983140 — CT BIOPSYVIEW
- K983167 — TRF
- K983209 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
- K983221 — IGG
- K983285 — ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS
- K983304 — SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
- K983356 — C4
- K983359 — IGA
- K983441 — C3
- K983507 — VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY
- K983693 — DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
- K983722 — STRATUS CS TROPONIN I CALIBRATOR
- K983857 — AUTOVENT 1500
- K981378 — DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
- K981666 — 2.5 MM LACTOSORB SCREWS
- K981691 — SILICONE SOFT RELINE
- K981772 — HALOLITE AAD SYSTEM
- K981845 — HAWK ANAESTHESIA INDUCTION UNIT
- K981886 — VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
- K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500
- K982016 — PIPER IPPB MODEL 2055
- K982454 — BIPAP VISION VENTILATORY SUPPORT
- K982748 — BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224
- K982769 — MITRA IMAGING INC. EXHIBIT
- K982773 — QUICKSET LIQUID AND POWDER
- K982775 — BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION
- K982870 — EPIFILM OTOLOGIC LAMINA
- K982878 — EARSCAN 3
- K982921 — MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
- K982959 — MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC
- K983101 — BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
- K983178 — COAMATIC HEPARIN
- K983206 — SMALL VAGINAL/RECTAL ELECTRODE
- K983247 — SUPER PORCELAIN ADDMATE
- K983294 — ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
- K983394 — MODIFICATION TO TIELLE HYDROPOLMER DRESSING
- K983513 — VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
- K983562 — MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700
- K983621 — NEEDLE GUIDE
- K980576 — VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
- K981600 — LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED
- K982611 — UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
- K982713 — RT DESKTOP
- K982717 — SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200
- K982776 — 9303 NEONATAL/ADULT VITAL SIGNS MONITOR
- K982836 — CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
- K982839 — CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
- K982919 — MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC
- K982932 — MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC
- K982985 — CITREX HOSPITAL SPRAY DISINFECTANT
- K983069 — PHILIPS DUO DIAGNOST
- K983245 — POS-T-VAC (AVP-1000)
Data sourced from openFDA. This site is unofficial and independent of the FDA.