FDA 510(k) clearances — page 366
clearances on record, most recent first.
Clearances — page 366
36,501–36,600 of 175,770- K133980 — PANTHEON ELECTROSTIMULATOR
- K140389 — CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4
- K140732 — CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
- K141644 — INNOVASIS CRANIAL SYSTEM
- K141771 — PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
- K141942 — MIDLINE II TI
- K141967 — PUREFILL OXYGEN COMPRESSOR
- K141990 — ENCORE HUMERAL SHOULDER STEM
- K142139 — SMR 40MM GLENOSPHERE
- K142215 — Power Twin21-50/Power Twin21-100
- K142550 — EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments
- K143001 — SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING
- K133166 — INS HILDEN TIBIAL ARZZT
- K133898 — NIOX VERO AIRWAY INFLAMMATION MONITOR
- K140130 — X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED
- K140244 — YONGHE
- K140246 — YONGFA
- K140355 — SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
- K140502 — ZOLL E SERIES ALS
- K140691 — IG_PLEX CELIAC DGP PANEL
- K140727 — CUTERA PICOSECOND LASER SYSTEM
- K140853 — STIMPOD ST2-3010 NERVE STIMULATOR
- K141555 — ADVANTAGE
- K141668 — CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K141674 — CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K141887 — OBSIDIAN PRESS (ALL CERAMIC AND POM)
- K141993 — NAKOMA ACP
- K142016 — CAPRI
- K142187 — LINK MP RECONSTRUCTION PROSTHESIS
- K142640 — Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator
- K142684 — FlexCath Select Steerable Sheath (10 French)
- K132230 — ICE ZIRKON TRANSLUZENT
- K133507 — GUIDOSS
- K133518 — MAXAN ANTERIOR CERVICAL PLATE SYSTEM
- K141649 — SPEX SUPPORT CATHETER
- K141909 — COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
- K142020 — LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400
- K142470 — E-Shield Multi-paried Subdermal Needle Electrodes
- K142950 — Acrobat Calibrated Tip Wire Guide
- K140193 — DUREX EMBRACE PERSONAL LUBRICANT
- K140738 — PASS LP SPINAL SYSTEM
- K141338 — LIAT STREP A ASSAY
- K141676 — RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
- K142489 — Unimed Disposable ECG lead wires
- K141238 — STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR
- K140008 — VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
- K140293 — TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM
- K140464 — STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
- K141126 — UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
- K141207 — NOVABONE BIOACTIVE STRIP
- K141312 — STERILUCENT PROCESS CHALLENGE DEVICE
- K141570 — IMPLANT STUDIO
- K141660 — NAWALUTION SKIN AND WOUND CLEANSER
- K141700 — PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
- K141745 — IQQA-BODYIMAGING SOFTWARE
- K141758 — T:SLIM INSULIN DELIVERY SYSTEM
- K141881 — RAPIDRESULTS
- K141941 — SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D
- K142088 — DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
- K142286 — NS3000 Holmium Laser System
- K142484 — Sternal Closure System
- K142517 — SoftVue
- K142575 — Bard RiteCath Intermittent Urinary Catheter
- K132853 — NOVAPACS
- K133810 — VC150 VITAL SIGNS MONITOR
- K140051 — KJ EXTERNAL IMPLANT SYSTEM
- K140052 — J2I IMPLANT SYSTEM
- K140493 — ELIA SCL-70S IMMUNOASSAY
- K140590 — ASTROGLIDE SENSUAL STRAWBERRY
- K142078 — VELASII THERAPY LASER SYSTEM
- K142138 — ISO-GARD MASK
- K142372 — Pico Way Laser System
- K142414 — Miltex N-Tralig Intraligamentary Syringe
- K142443 — Site-Rite 6 Ultrasound System with Pinpoint GT Technology
- K142851 — CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
- K142869 — Premium Surgiclip III
- K142878 — IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material
- K141539 — KUBTEC X250
- K141912 — AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
- K142050 — NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM
- K142053 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
- K142090 — REBOSSIS
- K142150 — AIS MODULIFT VBR SYSTEM
- K142199 — Ascendra Balloon Aortic Valvaloplasty Catheter
- K142245 — EpiAccess System
- K142441 — cryoICE croablation probe
- K142811 — IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
- K142864 — ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)
- K142984 — Leo Minor
- K132771 — KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS
- K140020 — HYPERQ ACS-100 SYSTEM
- K140383 — ALLOX2 TISSUE EXPANDERS
- K141221 — LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR
- K141459 — APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0
- K141686 — EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
- K141713 — SMARTGRAFT 200 SYSTEM
- K142063 — #8C RENEGADE DENTAL HANDPIECE
- K142082 — ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT
- K142084 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
- K142170 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP
Data sourced from openFDA. This site is unofficial and independent of the FDA.