FDA 510(k) clearances — page 370
clearances on record, most recent first.
Clearances — page 370
36,901–37,000 of 175,770- K141697 — XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
- K141885 — CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY
- K141895 — MOBILEDIAGNOST WDR
- K141985 — TRUE BA V BALLOON VALVULOPLASTY CATHETER
- K142181 — RANDOX ALDOLASE CALIBRATION SERUM
- K142325 — Veenstra Instruments VDC-506 Dose Calibrator
- K123329 — DA VINVI SURGICAL SYSTEM
- K134035 — TRANSONIC HCM 103 SYSTEM
- K140416 — TREKKER, TREKKER TRANSIT
- K141069 — Lung Density Analysis
- K141260 — ELECTRONIC PULSE STIMULATOR
- K141450 — AXIOM 2.8
- K141481 — TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
- K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
- K142048 — EMPRINT PROCEDURE PLANNING APPLICATION
- K142179 — D-KAT Z-YPE
- K142300 — Arrow GPSCath Balloon Dialation Catheter (150 cm)
- K142336 — GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
- K140017 — TRANSONIC HCM 102 SYSTEM
- K140377 — XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)
- K140496 — Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
- K141108 — YUSHENG
- K141405 — MOBIS II ST SPINAL IMPLANT
- K142309 — GEM Flow COUPLER Device and System
- K140039 — POLYCRYL
- K140362 — KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
- K140758 — M-PM-DISC (PINK)
- K140912 — SOMATOM SCOPE/SOMATOM SCOPE POWER
- K140928 — ABPM7100
- K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
- K141122 — HARMONIC SCALLOP BLADE, GENERATOR G11
- K141137 — STEREOS WORKSTATION
- K141321 — GLUCOSTABILIZER INSULIN DOSING CALCULATOR
- K142295 — Sirius Femoral Stem, Size 30A
- K142306 — Flower Upper Extremity Plating Set
- K133983 — INTRA. OX HANDHELD TISSUE OXIMETER
- K140050 — NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
- K140367 — ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
- K140608 — MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
- K141025 — ARTIMES BALLOON DILATATION CATHETER
- K141033 — SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV
- K141235 — PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
- K141384 — WHISPERJECT AUTOINJECTOR
- K141419 — ZVPLASTY
- K141439 — ORTHODONTIC ACRYLIC (NOT FINALIZED)
- K141602 — DX-D IMAGING PACKAGE
- K141949 — CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM
- K141971 — BIOGRAPH TRUE PET/CT FAMILY SOFTWARE
- K142008 — MYLABSEVEN, MYLABALPHA
- K142077 — MYLABGAMMA
- K142134 — C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES
- K142223 — Pilot Pro Diode Laser
- K142225 — Pilot Elite Diode Laser
- K142226 — Pilot Ultra Diode Laser
- K142241 — LARIAT sulture Delivery Device
- K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
- K140429 — CRANE ACRYLIC HERBST APPLIANCE
- K140841 — TABLO CARTRIDGE
- K140991 — RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE
- K141079 — OPTIMEDICA CATALYS PRECISION LASER SYSTEM
- K141425 — ELITE + LASER SYSTEM
- K141601 — IASSIST KNEE SYSTEM
- K130742 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K131983 — ITRAC CERVICAL TRACTION SYSTEM
- K134040 — BTL-9000; BTL-9000 RADIOFREQUENCY MODULE
- K140167 — RENAISSANCE X SYSTEM
- K140195 — SURGICAL DRAPE
- K140390 — TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS
- K140488 — CONTACT LENS CASE
- K140780 — KEGEL SMART, KEGELSMART PEARL
- K140866 — TABLO CONSOLE
- K141464 — NOVAGUARD S A SAFETY SYSTEM
- K141565 — GLOBE-TROTTER GT5400
- K141835 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS
- K141937 — TRIDENT FUSION IMPLANT
- K142213 — VIA SPINOUS PROCESS FIXATION SYSTEM
- K142230 — Apollo Suture Anchor System and Titan Screws
- K142259 — Direxion Torqueable Microcatheter
- K142423 — EyeSuite Imaging
- K131340 — POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
- K133963 — SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
- K133976 — FUJIFILM ENDOSCOPIC CO2 REGULATOR
- K141068 — ZEISS CATARACT SUITE MARKERLESS
- K141156 — SPACELABS HEALTHCARE TELEMETRY RECEIVER
- K141244 — NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)
- K141706 — ECARE COORDINATOR (ECC)
- K142182 — FRIMAP ADAPTER CONNECTOR (MAC)
- K142395 — SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
- K133584 — IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
- K141337 — ARENA-C
- K141541 — XIDF-AWS801, ANGIO WORKSTATION, V5.31
- K141551 — PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
- K141873 — RANGE/MESA/DENALI SPINAL SYSTEM
- K141924 — HD BLOOD PRESSURE MONITOR
- DEN130031 — NEPHROCHECK TEST SYSTEM
- K131968 — LONGFIAN OXYGEN CONCENTRATOR
- K132245 — AJAX DENTAL UNIT
- K133324 — SURESUBTRACTION LUNG
- K133739 — TRUSCULPT
- K133895 — DEKA SMARTXIDE LASER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.