FDA 510(k) clearances — page 774
clearances on record, most recent first.
Clearances — page 774
77,301–77,400 of 175,825- K013950 — VENTED VIAL ACCESS DEVICE
- K013969 — MINIBLASTER
- K014097 — GE LOGIQ 5
- K014108 — MAC 5000 ECG ANALYSIS SYSTEM
- K014250 — 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114
- K013243 — COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
- K013385 — NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
- K013529 — POINT 4 TRANSLUCENT MODIFIED
- K014049 — EPOCA CODR STEM AND HEAD
- K010933 — SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY
- K011190 — SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
- K011238 — RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
- K011842 — SABRE COMPAC
- K011855 — WAMPOLE HS-CRP ELISA
- K011876 — DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
- K013062 — BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
- K013365 — PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS
- K013366 — PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
- K013387 — DATEX-OHMEDA S/5 WEB VIEWER
- K013421 — LIFEGUARD NASAL CPAP MASK AND ACCESSORIES
- K013589 — CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
- K013592 — EXTREMITY COIL
- K013648 — VIABAHN ENDOPROSTHESIS
- K013671 — L-25 ABSORBABLE SURIGCAL SUTURE
- K013695 — MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
- K013718 — GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
- K013724 — BICART
- K013757 — ROCHE ACETAMINOPHEN
- K013775 — TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
- K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
- K013976 — BOEHRINGER MRI SUCTION REGULATORY
- K014078 — ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM
- K014080 — APEX ADULT HOLLOWE FIBER OXYGENATOR
- K014083 — HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
- K014100 — OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
- K014130 — NLITE SYSTEM
- K011537 — DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS
- K012275 — PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
- K013345 — INCARE INTERMITTENT CATHETER
- K013384 — SHARGHP A.V. FISTULA NEEDLE SET
- K013523 — CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
- K014007 — DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
- K014084 — NYCOCARD CRP CONTROL
- K014191 — M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
- K013174 — PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
- K014037 — SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
- K011564 — NEOLEAD
- K013171 — 3420 DIGIT PULSE OXIMETER, MODEL 3420
- K013311 — MODIFICATION TO: POCKETVIEW ECG SOFTWARE
- K013319 — NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
- K013506 — YELLOW SPECIAL
- K013601 — NUMED MULLINS PTA CATHETER
- K014182 — TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS
- K003689 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
- K013304 — BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
- K013514 — PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
- K011202 — MSI BIPOLAR SHEATH
- K012029 — REMEDY MODEL 2Z12
- K012839 — AUROPAL, ORDER-NO.: 2101
- K013556 — MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
- K013942 — POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)
- K014091 — STRYKER PAINPUMP
- K013586 — MAGNETOM TRIO SYSTEM
- K013721 — SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
- K011406 — SPINAL MESH SYSTEM
- K011691 — KIMSTIM AURICULAR ELECTRODE
- K011887 — AVALON CUP SYSTEM
- K011939 — FOTONA DUALIS, FOTONA DUALIS PLUS
- K012183 — BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
- K013289 — BIOTEQUE VAGINAL PESSARIES
- K013563 — LONG TROCHANTERIC NAIL SYSTEM
- K013678 — VICTORCH MEDITEK'S HCG TEST CARD
- K013702 — VICTORCH HCG TEST STRIP
- K013915 — D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER
- K013991 — PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
- K014076 — MODIFICATION TO TSRH SPINAL SYSTEM
- K011589 — CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M
- K012731 — SOLO-CARE PLUS MULTIPURPOSE SOLUTION
- K013225 — INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
- K013445 — OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES
- K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
- K013591 — XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
- K013649 — SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
- K011702 — VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
- K011832 — VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
- K011889 — ULTRA -THIN SDS BALLOON DILATATION CATHETER
- K011953 — WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA
- K011960 — LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)
- K012514 — DIGIPAN / DPI
- K012569 — MODIFICATION TO: INJECTABLE MIMIX
- K013056 — GELCLAIR CONCENTRATED ORAL GEL
- K013193 — MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
- K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
- K013436 — NORMATEC PCD
- K013466 — SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
- K013482 — ABUSCREEN ONLINE OPIATES 300 / 2000
- K013527 — MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
- K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K013606 — ACS 180 HOMOCYSTEINE ASSAY
- K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.