FDA 510(k) clearances — page 963
clearances on record, most recent first.
Clearances — page 963
96,201–96,300 of 175,890- K964749 — COVERAGE HBV
- K962447 — EQUINOX DIGITAL EEG SYSTEM
- K962528 — OLYMPUS MOBILE CHAIR/COUCH
- K962612 — BILIBED PHOTOTHERAPY LAMP
- K963669 — GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
- K963679 — LOVING SMARTER - SAFER SEX
- K963689 — RECOVER ADULT VEIN WARMER
- K963691 — COURIER BALLOON DILATATION CATHETER
- K963728 — THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
- K963746 — IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
- K963802 — SHUNT TAP
- K963806 — CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)
- K963824 — LI'S ITCH STOPPER
- K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
- K963963 — MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
- K963979 — ULTRADENT UNIVERSAL DENTIN SEALANT
- K963988 — INTRAVASCULAR INFUSION DEVICE
- K964071 — ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR
- K964123 — REUSABLE TROCAR WITH SLEEVE (COMMON)
- K964241 — BRENNEN MEDICAL GLUCAN II WOUND DRESSING
- K964429 — SUNGLASSES OR MULTIPLE
- K964683 — DIGIFOCUS ITE
- K950719 — OES UROLOGY
- K962855 — ULE-2, MULE-2, HAND ACCESSORY KIT
- K963159 — CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES
- K964469 — 700-F SERIES STIMULATION ELECTRODES
- K954505 — EZ STIM
- K954523 — THERMOSCAN INSTANT THERMOMETER MODEL IR-6000
- K955031 — MAXISTIM
- K960734 — HAEMOCELL SYSTEM 350 OR S350
- K960771 — SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM
- K961138 — ESORT II + 400 SERIES MONITOR
- K961223 — MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
- K961908 — THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
- K961984 — PORPHOBILINOGEN (PBG)
- K962598 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
- K962625 — VITAJET
- K962734 — CEDIA DAU BENZODIAZEPINE ASSAY
- K962915 — ACTIS (VENOUS FLOW CONTROLLER)
- K963692 — VERDICT PCP
- K963835 — DIGOXIN ENZYME IMMUNOASSAY
- K963852 — KSEA THERMOCOAGULATOR (MODEL 265100 20)
- K963924 — LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70
- K964775 — ARDENT FUTURA NON GAMMA-2
- K953990 — TRANSFLOW TEST
- K961643 — MEDICOTEST ECG ELECTRODES
- K961937 — SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM
- K962314 — HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
- K962608 — SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
- K962661 — ML MICROKERATOME BLADE
- K962880 — SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
- K963204 — DMS-1000C DERMOABRADER
- K963796 — KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS
- K963885 — ULTIMA FX FEMORAL HIP STEMS
- K963956 — PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT
- K964334 — EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)
- K964458 — ELLIS EXTERNAL MINI-FIXATOR SYSTEM
- K964500 — ACUMED TENSION BAND PIN
- K965256 — DMS-1000C DERMOABRADER
- K950259 — COUPLING DEVICE FOR DENTAL PROSTHESIS
- K955073 — KSEA THERMOFLATOR (MODEL 26 4320 20)
- K961607 — VIRAPUMP II (MODELS AND MODEL M)
- K962256 — GALILEO HYSTEROSCOPES AND LAPAROSCOPES
- K962969 — MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA
- K963276 — THE SAFETY 1ST DIGITAL PACIFIER
- K963624 — PHILIPS SLI SERIES LINEAR ACCELERATOR
- K963743 — MANAN PROSTATE UNI-LOCK
- K963877 — AHS OMEGA CONCEPT
- K963878 — AHS OMEGA HF
- K963922 — ALPHA-DENT ROOT CANAL SEALER & FILLER
- K964040 — TRUBYTE SOFT RELINE SYSTEM
- K964216 — STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
- K964421 — REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK
- K964475 — CLINICAL BLOOD GAS MIXTURES
- K964566 — OZARK 20
- K964567 — EL DORADO 75
- K964568 — OZARK 46
- K964569 — EL DORADO 58
- K964572 — PALLADIA 76
- K964573 — PIEDMONT 70 (CH-35)
- K964603 — ARTICULAR HEARING AIDS
- K935778 — VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM
- K960389 — HYPERBARIC CHAMBER
- K961530 — GISH RELIANCE OXYGENATOR (MODEL HFO)
- K961633 — CD HORIZON SPINAL SYSTEM
- K962203 — WHISPER SWIVEL II EXHALATION PORT
- K962276 — HEMAGEN ENA DSDNA KIT (EIA METHOD)
- K962557 — GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
- K963128 — NOVAGEL SILICONE GEL SHEETING
- K963770 — BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS
- K963958 — IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
- K964102 — TENET TIBIAL FRACTURE SUPPORT
- K964175 — VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES
- K964243 — HUMERUS WIRES
- K950550 — XH-1 NEUROMUSCULAR STIMULATOR
- K952315 — SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE
- K962591 — FOOT WEIGHT ALARM
- K963231 — EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST
- K963328 — AMS AMBICOR PENILE PROSTHESIS
- K963558 — CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.