FDA 510(k) clearances — page 916
clearances on record, most recent first.
Clearances — page 916
91,501–91,600 of 176,637- K974897 — COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
- K980025 — PEREGRINE TAPERED DIFFUSION PROBE
- K980027 — PEREGRINE SHIELDED DIFFUSION PROBE
- K980919 — ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
- K972992 — CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS
- K974172 — SILGEL TOPICAL GEL SHEET
- K974210 — SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
- K974636 — FLOSI RIGID GAS PERMEABLE CONTACT LENS
- K974902 — JMS APHERESIS NEEDLE
- K980043 — CARESIDE CREATININE
- K980114 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
- K980818 — POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)
- K972919 — BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
- K973652 — DUOCLIPPER TITANIUM CLIPS
- K974143 — KMC NEWSKIN
- K974855 — PHORESOR II, MODEL PM900
- K974877 — CRANEX TOME CEPH, OR CRANEX TOME
- K974878 — E3 MICROPROBE
- K974896 — LASERSCOPE EL LASER SYSTEM AND ACCESSORIES
- K980124 — SOFSILK SUTURE
- K980153 — DRUG CHECK
- K980482 — TRIANGLE SLING
- K980560 — FOTONA SKINPLUS LASER SYSTEM
- K980718 — PARA-CARE
- K980758 — 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS
- K980769 — WINDMERE MODEL DS-2 FOOT BATH
- K971914 — TECA NCS ELECTRODE SYSTEM 2000
- K973123 — EA-D IGG ELISA TEST SYSTEM
- K980900 — N-ASSAY CPK-L
- K980902 — N-ASSAY L AST/GOT
- K972300 — CROSS-CHECKS P
- K973419 — DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
- K980240 — ELECSYS CA 125II ON THE ELECSYS 1010
- K980564 — MEDI-GRIP (BEIGE 43)SURGICAL GLOVES
- K980714 — BCI 3401 HANDHELD PULSE OXIMETER
- K980802 — NITRILE EXAM GLOVE, POWDER-FREE, BLUE
- K980806 — AFFINITY MEDICAL PATIENT CABLE SYSTEM
- K974737 — ASTRA TECH IMPLANT DENTAL SYSTEM
- K974828 — BRANEMARK SYSTEM(R) EBON(TM) FIXTURE
- K974906 — ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
- K980089 — 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000
- K980090 — ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
- K980230 — QUANTA LITE B2 GPI SCREEN
- K980301 — IP-16
- K980574 — AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0
- K971910 — MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)
- K973002 — HURRISEAL DENTIN DESENSITIZER
- K973548 — MERCURY DENTAL
- K973740 — ROUND WINDOW E-CATH
- K974679 — THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
- K974806 — VYGON NEO-SUMP
- K974819 — SELECTCELLS(TM) MINI
- K980218 — METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K980488 — STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
- K980533 — ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
- K980539 — SOLOBOND M
- K980722 — TRIMAX RADIOGRAPHIC CASSETTE
- K970599 — TOWNLEY PEDICLE SCREW PLATING SYSTEM
- K974611 — MICRO-STRIP FOR AMPHETAMINE METABOLITES
- K974788 — CRE(TM) BALLOON DILATATION CATHETER
- K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
- K974876 — BIONX DISTAL RADIUS SCREW
- K974881 — TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
- K980062 — MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE
- K980119 — ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
- K980666 — INFINITY AST REAGENT (PROCEDURE NO. 51)
- K980872 — RAPID DRUG SCREEN' 8 PANEL
- K962615 — TUMORLOCALIZER MRI
- K963794 — PUNCTURENEEDLE
- K970093 — TYROSINE 50-HOUR REAGENT KIT
- K973532 — STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
- K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE
- K974202 — PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
- K974464 — ORATEC SPINECATH INTRADISCAL CATHETER
- K974793 — ELMED ESU 120 M/M DIGITAL
- K980001 — JENASCAN
- K980242 — IL TEST HEPARIN
- K980313 — SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
- K980523 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
- K980561 — DERMIUM
- K980565 — LD2000 SERIES
- K980698 — ASTRA TECH IMPLANTS - DENTAL SYSTEM
- K980824 — A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR
- K963642 — INCL II ENDOSCOPE
- K972162 — ELECSYS CA 125 II
- K972225 — UFR FIBEROPTIC CABLE
- K973687 — SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM
- K974186 — ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
- K974544 — ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER
- K974725 — BIOZ.COM SYSTEM
- K974726 — SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
- K974732 — NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000
- K974740 — DEPUY TRI-LOCK HIP STEM
- K974746 — M1765A ECG MANAGER
- K974785 — AUTO-DRIVE BONE SCREW
- K974908 — SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
- K980023 — ENDOPATH AND PROXIMATE LINEAR CUTTERS
- K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
- K980377 — FONIX FP35 HEARING AID ANALYZER
- K980454 — LYSONIX ASPIRATION PUMP
Data sourced from openFDA. This site is unofficial and independent of the FDA.