FDA 510(k) clearances — page 802
clearances on record, most recent first.
Clearances — page 802
80,101–80,200 of 175,825- K010347 — LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE
- K010356 — LATEX EXAMINATION GLOVES-POWDER FREE
- K010414 — R & D DESIGNATION AP-035
- K010568 — ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
- K010610 — RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
- K010611 — R & D DESIGNATION AP-047
- K000655 — PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE
- K001734 — FOGARTY VALVULOTOME, MODEL 700091
- K002829 — DJ ORTHOPEDICS FEMORAL ANCHOR
- K003345 — AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
- K003993 — DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)
- K004006 — SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
- K010013 — LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
- K010088 — REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
- K010089 — REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
- K010090 — XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
- K010256 — ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL
- K010277 — AMS FASCIAL-ANCHORING SYSTEM
- K010403 — PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700
- K000977 — COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
- K003752 — BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)
- K003835 — JAS MAGNESIUM REAGENT
- K010389 — CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
- K010598 — SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
- K010636 — FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT
- K010718 — FLEXI-SITE SP02 EAR SENSOR
- K000724 — MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300
- K002154 — K.E.A.T.
- K002286 — LDOB OCCLUSION BALLOON CATHETER
- K003156 — BLASTASSIST SYSTEM
- K003163 — SYNVITRO FLUSH
- K003404 — SUPRASPERM SYSTEM
- K003897 — ENDIUS BIPOLAR SHEATH
- K003929 — NIROYAL BILIARY PREMOUNTED STENT SYSTEM
- K010037 — DAUM DOUBLE-SHOOT BISOPSY GUN
- K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540
- K010364 — MCC-MIV ONE 2 ONE SOFTWARE
- K010497 — SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
- K010515 — MODIFICATION TO SYNERGY SPINAL SYSTEM
- K002507 — TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
- K002696 — WHITTLESTONE BREASTPUMP
- K002789 — MEDEVIEW SYSTEM
- K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
- K003939 — VENTURE HOME FILL II, MODEL IOH 200
- K003951 — PECTOFIX STERNAL REPAIR WIRE
- K003960 — DJ ORTHOPEDICS TIBIAL ANCHOR
- K003971 — AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR
- K010058 — IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK
- K010222 — OHMEDA MEDICAL GIRAFFE INCUBATOR
- K010686 — KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C
- K001412 — PM 1800 CONSERVING DEVICE
- K001535 — ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
- K001581 — LACTOSORB 5.0 MM WASHER
- K003185 — FS ACTIVATOR III
- K003271 — MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
- K003352 — ESCREEN SYSTEM
- K003923 — APEX MODULAR ZIRCONIA FEMORAL HEAD
- K010031 — NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
- K010310 — MODIFICATION TO TRIDENT ALL POLY CUP
- K010482 — ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1
- K010498 — WRISTWATCH BLOOD PRESSURE MONITOR A46
- K010560 — PORTRAIT FEMORAL COMPONENT
- K010608 — MODIFICATION TO LAP TOP VENTILATOR (LTV)
- K010640 — SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER
- K010642 — PLEURX PLEURAL CATHETER AND DRAINAGE KITS
- K010649 — EXHALE DOPPLER SYSTEM
- K002665 — WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
- K003584 — NEOLYNX SCREENING APPLICATION MANAGER
- K003747 — C1-INHIBITOR MICROTITER ASSAY DEVICE
- K003846 — ACCU-CHEK INFORM METER
- K003910 — NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
- K003975 — BAUMER CEMENTED HIP PROSTHESIS
- K003976 — BAUMER MULLER HIP PROSTHESIS
- K003979 — MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
- K003984 — SUPER REVO SUTURE ANCHOR
- K010019 — STERILE SUBDERMAL NEEDLE ELECTRODES
- K010052 — RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
- K010087 — XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
- K010535 — TRIFIX SPINAL FIXATION SYSTEM
- K010589 — MICROWAVAE DELIVERY SYSTEM #MW2000
- K010217 — 4 PORT, 4 WAY STOPCOCK
- K010224 — NPAC MULTI-USE THERMOMETER, MODEL TD400
- K002254 — COOK PRESSURE MONITORING CATHETER
- K002706 — ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
- K003449 — E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS)
- K003913 — HINT AUDIOMETER, OR HINT
- K003952 — INDIGO LASEROPTIC TREATMENT SYSTEM
- K003953 — INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001
- K003965 — MRI SAFE INSTRUMENTS
- K003995 — SPECULITE/ORALLITE
- K004014 — MD 30 COMPACT
- K010084 — REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
- K010206 — DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
- K010218 — VISTAKON (HEFILCON C) CONTACT LENSES
- K010223 — BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
- K010266 — TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
- K010287 — SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
- K010298 — MN-4 COARSE MANIPULATOR
- K010409 — CBC-SF
- K010445 — PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.