FDA 510(k) clearances — page 1010
clearances on record, most recent first.
Clearances — page 1010
100,901–101,000 of 175,890- K945961 — CALCITONIN IMMUNOASSAY KIT
- K946258 — MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT
- K951124 — CAD-2000 CARDIAC ASSIST DEVICE
- K951362 — THYROGLOBULIN EIA TEST KIT
- K951364 — MICROSOMAL EIA TEST KIT
- K951946 — HYSTEROSYS FLEXIBLE HYSTEROCOPE
- K952467 — TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)
- K952514 — COACUTE HEPARIN
- K952727 — MRC-5 CELL CULTURE VIAL
- K952751 — BIOCIRCUITS IOS T4/TU TEST CARTRIDGES
- K952818 — ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
- K953247 — GIBSON ID A.E. TEST
- K953302 — FACS LOADER SYSTEM
- K953714 — ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
- K953837 — BIOCIRCUITS IOS T4 TEST CARTRIDGE
- K953935 — MED-TECH CLINICAL BLOOD GAS
- K954015 — ABG POINT LOK NEEDLE PROTECTION DEVICE
- K954048 — VARIANT HEMOGLOBINOPATHY PROGRAM
- K954190 — MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
- K954229 — ARGON ACCESSORY WITH BLADE & NEEDLE ELECTRODE, ADAPTER BOX
- K954291 — OPUS TDM CONTROLS
- K954590 — MAX-1000A/R1
- K954732 — ACCESS TOTAL BHCG ASSAY (MODIFICATION)
- K935998 — ENTERPRISE
- K943305 — OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
- K950223 — DISCOVERY GRAPHIC PORTABLE SPIROMETER
- K950247 — TS 564/PF
- K950739 — 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
- K951893 — LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS
- K952224 — STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
- K953458 — RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN
- K953959 — PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES
- K953972 — ANGIOVISION VIEWING STATION
- K953973 — ANGIOVISION 1000
- K954037 — FIELD TREND
- K954227 — CEDIA DAU METHADONE ASSAY
- K954328 — CLEAN ROOM WHEELCHAIR
- K954391 — MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
- K954504 — K-DEFIB/PACE PEDIATRIC ELECTRODE
- K932436 — ECHOMARK INTRAUTERINE GUIDING CATHETER
- K932691 — PROTECTRODE SYSTEMS CONCENTRIC
- K935716 — KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE
- K940316 — HYSTERSCOPE
- K951421 — GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES
- K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
- K951800 — CMV IGG HUMAN SERUM CONTROLS
- K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
- K952277 — SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM
- K953929 — MID-STREAM COLLECTION SET-STERILE
- K953980 — KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT
- K954882 — RIZA-RIBE NEEDLE (MODIFICATION)
- K935767 — SIMS SILO NEEDLE DE-ACCESS ENCLOSURE
- K942855 — NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
- K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES
- K944351 — SMARTDOSE IV PREFILLED INFUSION CONTAINER
- K944352 — SMARTDOSE III INFUSION CONTAINER
- K946319 — INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
- K946345 — INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM
- K952219 — SUCTION TIP CLEANER CUP
- K953912 — JACOBYSCOPE
- K954025 — SIME SURGICAL POWDERFREE
- K954051 — SIME POWDERFREE PLUS
- K954077 — UNITRAX V40 MODULAR ADAPTOR
- K954348 — GLANZ CARCINOMA GAUGE, KSEA
- K954433 — VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM
- K954491 — HYDROCELL NASAL AND SINUS PACKS
- K954662 — THERMALASTIC/TRIPOLYVINALENE
- K954795 — AT2 & DOYLE STYLE (C-FLEX) VENT TUBES
- K954837 — DW260 19
- K954876 — AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA
- K954880 — LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)
- K933878 — ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT
- K940001 — PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)
- K945376 — DOC'S PROPLUGS EAR PLUGS
- K945578 — NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
- K950472 — DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
- K950475 — DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
- K951650 — CLINICAL PROTON SPECTROSCOPY OPTION
- K951685 — AURAFLEX TESTOSTERONE CALIBRATOR PACK
- K951723 — GE B510 TRANSDUCER
- K952063 — XXL BALLON DILATATION CATHETER
- K952565 — LYOFOAM EXTRA
- K952682 — LOKKI DT
- K952898 — GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
- K952901 — THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR
- K952902 — THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR
- K952932 — THE TULIP COMPANY BRANSON #1 ELEVATOR
- K952951 — THE TULIP COMPANY BRASON NERVE HOOK & DISSECTOR
- K952953 — THE TULIP CXOMPANY BRANSON #2 ELEVATOR
- K952958 — THE TULIP COMPANY BRANSON OVERSHEATH
- K953095 — PHILIPS EASYVISION
- K953362 — PREMIER EHEC
- K953621 — EVT-3300
- K953780 — ACCESS ALLERGEN DOG EPITHELIM
- K953794 — SHARPLAN LASERS, INC. SURGICAL DIODE LASER
- K953883 — ACCESS LOW LEVEL IGE CONTROLS
- K954106 — THERATEST LAB, INC., EL-ANASCR KIT
- K954127 — BIOFEEDBACK DEVICE
- K954225 — MED-TEC HAND GRIP
- K954355 — ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
Data sourced from openFDA. This site is unofficial and independent of the FDA.