FDA 510(k) clearances — page 364
clearances on record, most recent first.
Clearances — page 364
36,301–36,400 of 175,770- K142917 — BP652N (HEM-6300-Z)
- K142973 — Resolution Clip
- K143141 — CD HORIZON Spinal System
- K140041 — ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
- K142594 — nva, nvp, nvt
- K143066 — Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
- DEN130045 — HEARTFLOW FFRCT
- K133434 — GENESIS II
- K140842 — DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
- K140859 — DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
- K140884 — SYMETREX LONG TERM HEMODIALYSIS CATHETER
- K141158 — APEX
- K141408 — RESOLVE BILIARY LOCKING DRAINAGE CATHETER
- K141741 — AQUILION PRIME, V6.00
- K142029 — MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
- K142501 — Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- K142695 — Cytosponge Cell Collection Device
- K142938 — G3 Active Plate Large Fragment System
- K143089 — WS80A Diagnostic Ultrasound System
- K143091 — Surgisleeve Wound Protector
- K133989 — AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
- K140382 — AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
- K140535 — PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
- K140768 — TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT
- K141231 — ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
- K141333 — ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
- K141523 — ALLY UPS
- K141537 — IN:C2 SPINAL FIXATION SYSTME
- K141792 — GENESIS TOUCH SYSTEM
- K141928 — COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
- K142065 — TURNPIKE CATHETER
- K142118 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE
- K142203 — Atricure Cryo Module System; cryoICE cryoablation probe
- K142270 — LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE
- K142272 — SNaP Wound Care System
- K142299 — CoRoent Small Interlock System
- K142367 — Hospira Primary Sets
- K142389 — Variolink Esthetic
- K142393 — PREDICATE III GUIDEWIRE
- K142394 — Masimo Root Monitoring System and Accesories
- K142424 — DR300 HOLTER MONITOR
- K142461 — VASCU-GUARD Peripheral Vascular Patch
- K142863 — Univers Rivers Shoulder Prosthesis System
- K143054 — Sherpa Pak Kidney Transport System
- K143074 — Sherpa Pak Cardiac Transport System
- K133766 — HUMICARE D900
- K140566 — SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE
- K140573 — WOUNDCLOT HEMOSTATIC GAUZE
- K140716 — OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE
- K141682 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
- K141939 — TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET
- K141940 — CONCHASMART COLUMN
- K141952 — ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
- K142072 — GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
- K142098 — SIGNA PET/MR
- K142147 — EEVA SYSTEM
- K142238 — MAYFIELD Skull Clamp
- K142290 — KangLi pedical screw spinal system
- K142403 — Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
- K142467 — IntelAir Nasal Airway Support System
- K142496 — Collagen Dental Membrane - Conformable IIBP
- K142802 — Atlas SPEEDER Head/Neck
- K142045 — XPERT FLU/RSV XC ASSAY
- K133348 — STIM PROBE
- K133362 — SGS DENTAL IMPLANT
- K133674 — PHILIPS IQON SPECTRAL CT
- K133997 — LG SMARTHEALTH
- K134006 — DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE
- K141377 — BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
- K141872 — SUDOSCAN
- K142183 — GLIDESHEATH SLENDER
- K142197 — ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
- K142434 — ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1
- K142525 — PK Lap Loop
- K142668 — Lesion-Loc Iodine I-125 Seed/Needle
- K142681 — ZEUS (ZIO ECG Utilization Service) System
- K142868 — 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin
- K143026 — Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
- K143106 — VEGA Knee System
- K143261 — 2.3MP Color LCD Monitor, RadiForce MX242W
- K141896 — COROENT SYSTEM
- K142012 — FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
- K142023 — LUNA INTERBODY SYSTEM
- K142062 — SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
- K142100 — AIXPLORER
- K142303 — NeumoFilt Ergo/Neumo Filt BiteOn
- K142520 — Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
- K142585 — PhaLinx Hammertoe System
- K142978 — Audit MicroControls Linearity LQ Special Diabetes
- K143027 — Xario 200, V3.0
- K143038 — Gel-Block 10X embolization pledgets
- K143234 — MaxZero Administration Sets
- K133303 — PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
- K140497 — ECVUE MAPPING SYSTEM
- K140569 — ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
- K140910 — CENTERCROSS CATHETER
- K141194 — FM-3000 FETAL MONITOR
- K141263 — TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
- K141462 — VARIA-NCI
- K141640 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.