FDA 510(k) clearances — page 893
clearances on record, most recent first.
Clearances — page 893
89,201–89,300 of 176,637- K983388 — ONTRAK TESTCUP-ER
- K983390 — IS-ANTI-MPO IGG ELISA TEST SYSTEM
- K983418 — THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
- K983420 — THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO
- K983422 — THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
- K983423 — THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983425 — THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
- K983426 — THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC
- K983453 — PROCERA ALLCERAM FUSING MATERIAL
- K983464 — THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983465 — THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983545 — QUADRANT UNIBOND
- K983669 — OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
- K983740 — IS-ANTI-PR3 IGG ELISA TEST SYSTEM
- K983850 — DIMENSION AHDL CALIBRATOR
- K983894 — BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
- K983971 — CARDIAC MARKER CONTROL MODULE, MODEL CCCM
- K980492 — AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
- K980551 — SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
- K981853 — BONE INJECTION GUN (B.I.G.) DEVICE
- K982168 — SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
- K983046 — AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
- K983048 — AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
- K983125 — EPIDURAL CATHETER MODELS 1210/1200
- K983855 — FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F
- K980045 — CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
- K980182 — WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K982610 — OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)
- K982911 — FORTE
- K982924 — DUREX SENSIDOM LATEX CONDOM
- K982972 — SIGNA PROFILE SMALL HEAD COIL
- K982994 — SKULL BASE INSTATRAK SYSTEM
- K983111 — XRAY VISION
- K983143 — MARK 5000 PHASED ARRAY SHOULDER COIL
- K983181 — CYTOPREP
- K983380 — DUREX LUBRAGEL LATEX CONDOM
- K983428 — SAFETEX CERVICAL SCRAPER (PLASTIC)
- K983617 — 25-HYDROXYVITAMIN D 125I RIA KIT
- K983659 — PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
- K983812 — NAPA EIA ASSAY
- K983848 — ABBOTT AXSYM MYOGLOBIN
- K983980 — SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS
- K970811 — DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA +1 more
- K973171 — NIR BILIARY STENT
- K981964 — MEDI-TRACE 4103 NEONATAL ELECTRODE
- K982803 — HEARTLINK, MODEL II
- K983021 — METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC
- K983028 — FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
- K983085 — HEMOCOR HPH 700 HEMOCONCENTRATOR
- K983135 — BLOWER/MISTER
- K983357 — MUCOPREN SOFT RELINING SYSTEM
- K983361 — PANAVIA F
- K983582 — CARDIOBEEPER CB250
- K983786 — STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION
- K974241 — SCIMED INFORMER PRESSURE WIRE SYSTEM
- K980711 — HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
- K981072 — ESPRIT VENTILATOR
- K981885 — SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE
- K981911 — PROFA
- K982831 — AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
- K982906 — LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
- K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
- K983323 — DIGOXIN IMMUNOASSAY
- K983450 — STARRYSHINE GAUZE SPONGE
- K983460 — STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
- K983517 — SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
- K983578 — ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
- K983602 — CV PERI-GUARD AND VASCU-GUARD
- K983706 — MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
- K983771 — STRATEGY CORONARY WIRE GUIDE
- K973322 — DIAPACT CRRT
- K982843 — CMS-2000
- K982854 — MR COMPATIBLE LEVEEN NEEDLE ELECTRODE
- K982876 — HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
- K982902 — PERIPHERAL NERVE STIMULATION
- K982975 — DIGITAL ECG HOLTER RECORDER, MODEL DR512
- K983033 — ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE
- K983112 — RESPIRATORY HUMIDIFIER, MODEL # MR850
- K983554 — ALLDRESS, ABSORBENT FILM DRESSING
- K983603 — REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
- K983736 — ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER
- K980800 — LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
- K981871 — C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
- K982043 — BRENEB
- K982167 — CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
- K982840 — BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING
- K983266 — FIBREKOR POST SYSTEM
- K983478 — ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
- K973585 — PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
- K980895 — ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR
- K980999 — ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
- K981462 — QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300
- K981526 — ACE ALVEOLAR DISTRACTOR
- K982110 — POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
- K982410 — SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE
- K982435 — IRRIGATION SYRINGE KIT
- K982575 — MESH, SURGICAL, POLYMERIC
- K982813 — NATURALYTE, MODEL # 08-4004-1
- K982815 — ALPHATRAC, MODEL A200
- K982825 — BRENNEN MEDICAL BETA GLUCAN GEL
Data sourced from openFDA. This site is unofficial and independent of the FDA.