FDA 510(k) clearances — page 369
clearances on record, most recent first.
Clearances — page 369
36,801–36,900 of 175,770- K141200 — PADI-LOCK
- K141347 — EMERGE MEDICAL IM NAIL SYSTEM
- K141542 — NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
- K141664 — SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION
- K142268 — Varian Verification System (VVS)
- K142302 — BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
- K140577 — INNESIS PEEK TL CAGE
- K142364 — Barrx RFA Self Sizing Balloon Catheter
- K142450 — DIVERGENCE Anterior Cervical Fusion System
- K142460 — EXPEDIUM Spine System/Synapse System
- K130450 — SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE
- K140371 — FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)
- K141140 — COMP A-I-R
- K141286 — AER-O-SCOPE COLONOSCOPE SYSTEM
- K141422 — PROFLUORO FLUORIDE VARNISH
- K141476 — WAVELIGHT FS200 LASER SYSTEM
- K141547 — WINGMAN EXTENDABLE TIP SUPPORT CATHETER
- K141598 — FUSE COLONOSCOPY SYSTEM
- K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT
- K142113 — ESOPHYX2 HD
- K142258 — PolyCatch Retrieval Device
- K141290 — HELICAL RIDGE PEEK INTERFERENCE SCREW
- K141314 — SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION
- K141633 — PRO-PICC WITH VALVE TECHNOLOGY
- K142054 — IMACOR ZURA EVO IMAGING SYSTEM
- K142386 — Operating Room Light Handle Adapter
- K131817 — EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
- K133577 — CLYDESDALE(R) SPINAL SYSTEM
- K140369 — MEDLINE NEURO SPONGE
- K140380 — OPERA SWING
- K141075 — SINGLE-SITE WRISTED NEEDLE DRIVER
- K141097 — CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE
- K141113 — SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
- K141271 — AERODR SYSTEM 2
- K141380 — PROVOX FREEHANDS FLEXIVOICE
- K141490 — UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
- K141800 — PERFRACTION
- K141905 — PRO-LINK WEDGE SYSTEM
- K141935 — STRYKER S2 DRILL
- K142085 — DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
- K142339 — HEMASORB Resorbable Hemostatic Bone Putty
- K142418 — I.T.S. Hand Locking Plates System - HLS
- K133603 — PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
- K140088 — PHANTOM XL INSULATED DILATORS
- K140378 — FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT
- K140670 — ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
- K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
- K141150 — PTA BALLOON DILATATION CATHETER
- K141358 — CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
- K141804 — POLARIS SPINAL SYSTEM - HA COATED
- K141897 — SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
- K142000 — ESOFLIP ES
- K142383 — Optima XR200amx, Optima XR220amx
- K142408 — FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
- K142546 — TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
- K132121 — STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
- K133456 — POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
- K140097 — AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
- K140556 — CONCHASMART BREATHING CIRCUIT
- K140837 — LUCID LY
- K141591 — SMARTGRAFT 30 SYSTEM
- K141829 — GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
- K142123 — REACH ACCESS TELEMEDICINE DOSE CALCULATOR
- K142261 — Ultraverse 035 PTA Balloon Dilatation Catheter
- K142376 — Palomar Icon Aesthetic System
- K141103 — INTRAMEDULLARY NAIL AND SCREWS-NEONAIL
- K141483 — BIOSPACE BODY COMPOSITION ANALYZER
- K141500 — OPTIO-C ANTERIOR CERVICAL SYSTEM
- K141616 — STERILIZATION CASSETTE
- K142112 — 4WEB SPINAL IMPLANT PRODUCTS
- DEN140019 — T2CANDIDA AND T2DX INSTRUMENT
- K140077 — ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
- K140349 — STARBRIGHT 5% SODIUM FLUORIDE VARNISH
- K140719 — PICOSURE WORKSTATION
- K141255 — SIMEX SUBGLOTTIC ASPIRATION SYSTEM
- K133050 — ONE PLUS IMPLANT SYSTEM
- K133223 — XENMATRIX AB SURGICAL GRAFT
- K133298 — ENDO SMART
- K133717 — LONGBOW SPACER SYSTEM
- K133753 — MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
- K133852 — APOLLO BALLOON DILATATION CATHETER
- K140634 — extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit
- K141437 — XLR8 PLUS (XLR8+)
- K141453 — ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
- K141472 — VANTAGE ELAN
- K141669 — SURGIMAP
- K141806 — CLEAR GUIDE ONE
- K141998 — SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
- K142397 — Predicate III Guidewire
- K142527 — Extension Set with BD Q-Syte Luer Access Split Septum
- K130312 — IROOT FM
- K131173 — FIA Blood Glucose Monitoring System (G2)
- K140399 — EBM IDO VIEWER
- K140557 — MIVI 6F GUIDE CATHETER
- K140613 — MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
- K141074 — CORTEX ID SUITE
- K141477 — DISCOVERY IQ
- K141607 — DENTAL IMAGING SOFTWARE
- K141670 — ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
- K141696 — EDWARDS ESHEATH INTRODUCER SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.