FDA 510(k) clearances — page 1037
clearances on record, most recent first.
Clearances — page 1037
103,601–103,700 of 175,890- K944485 — 4000 AU ULTRASOUND IMAGING SYSTEM
- K945155 — AIRIS
- K945413 — MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT
- K945698 — COLTOLUX 3, COLTOLUX 4
- K945792 — IM512P
- K945796 — SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM
- K946081 — FLUOREX DTA-400A
- K950106 — COLTOLUX LIGHT METER
- K950611 — EXPERT MORPHOMERTY SOFTWARD
- K950687 — EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)
- K950721 — FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
- K950807 — SUNBLOCKER SUNGLASSES
- K950862 — KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES
- K951596 — EARCLEAR
- K951732 — NEZHAT-DORESEY PENCIL-GRIP HANDLES
- K951875 — STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM
- K951883 — PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
- K951895 — ACCU-BEAM 300W XENON LIGHT SOURCE
- K951971 — XENON LIGHT SOURCE
- K951995 — KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR
- K925433 — THE STACHROM HEPARIN ASSAY KIT
- K933524 — EXTENTION SET
- K935842 — RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE
- K940179 — ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011
- K942428 — CMT-1000
- K942881 — TC 3000
- K943394 — PROSTAT CONTROL
- K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD
- K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULE
- K943420 — ORTHODONTIC ELASTOMERIC CHAIN
- K943421 — ORTHODONITC ELASTOMERIC SLEEVING
- K944094 — TRIADYNE
- K944190 — LIFECARE 175 INFUSER, MODIFICATION
- K945267 — OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES
- K945542 — ALTRA FLUX(TM) 170 HEMODIALYZER
- K945728 — CATCO THORACIC CATHETER
- K946165 — CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM
- K950284 — SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR
- K950299 — CEREC 2
- K950410 — CONAIR BODY AND SOLE
- K950629 — ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR
- K951238 — SAFE-TIPS EZ
- K951476 — E-PACK PROCEDURE KITS
- K951515 — MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER
- K951555 — FUJI IX
- K951776 — BAND SEATER
- K951864 — PRIME & BOND DIRECT COMPOSITE BONDING AGENT
- K951867 — PERMAQUIK BONDING PRIMER
- K951985 — PRECISION BIPOLAR COAGULATOR
- K931265 — FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND
- K935080 — INSALL-BURSTEIN II
- K935802 — SELECT(R) SHOULDER ALL POLY GLENOID
- K936159 — NATURAL-KNEE II SYSTEM
- K940273 — NOBLES-LAI VIDEO IMAGING SYSTEM
- K941722 — FNA BIOPSY NEEDLE
- K944678 — NIHON KOHDEN ELECTROENCEPHALOGRAPH
- K950070 — MITEK TOGGLE ANCHOR(TM)
- K950384 — SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
- K950483 — HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
- K950594 — HEMI-SHOULDER PROSTHESIS
- K950798 — POSTERIOR CAPSULE SHIELD
- K950800 — PRO-PAK FOR OMS DIPLOMATE
- K951083 — PROFORM CEMENTED FEMORAL COMPONENT
- K951696 — ENDOTRACHEAL TUBE
- K951697 — PEDIATRIC ENDOTRACHEAL TUBE
- K952010 — PRIMA VENTILATOR HOSES
- K952011 — PRIMA BREATHING BAGS
- K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT
- K952013 — PRIMA GUEDEL AIRWAYS
- K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
- K952015 — PRIMA FILTER
- K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
- K952017 — PRIMA MAPLESON D CIRCUIT
- K952018 — PRIMA COAXIAL CIRCUITS
- K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS
- K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS
- K952021 — PRIMA HYUPERINFLATION SYSTEM
- K952022 — PRIMA VOLUMN VENTILATORSS
- K930272 — HEMAGEN CHAGAS' KIT (EIA METHOD)
- K930578 — AT33 EMG
- K933523 — I.V. FILTER SET
- K935471 — FILTRYZER(TM)
- K935525 — PHOTOTHERAPEUTIX MODEL 2480AB
- K935807 — ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
- K940615 — ACCUTEST
- K941462 — CARDIOVIT AT-5C
- K942049 — BIOMERIEUX HEMOLAB COFAC II
- K942050 — HEMOLAB COFAC IX
- K944937 — SYNTHETIC ABSORBABLE SUTURE
- K945053 — LF CT HIG PRESSURE CATHETERS
- K945065 — DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
- K945797 — STERILE EMPTY PCA SYRINGE
- K945904 — SCIMED(R) VENTURE(TM) II INFUSION CATHETER
- K946276 — QUICKVUE(R) CHLAMYDIA TEST
- K950394 — TIBIA-TALUS-CALCANEUS NAIL
- K950852 — CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
- K951064 — DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC
- K951295 — STERRAD STERILIZATION POUCH
- K951873 — STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM
- K951874 — STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.