FDA 510(k) clearances — page 414
clearances on record, most recent first.
Clearances — page 414
41,301–41,400 of 175,770- K130590 — AAP CANNULATED SCREW 2.0
- K120250 — FIBRILLAR COLLAGEN WOUND DRESSING
- K123483 — DIODE LASER
- K121804 — PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM
- K122210 — NEWFIX EXTERNAL FIXATION SYSTEM
- K122539 — MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
- K122868 — BIOSPHERE BIOACTIVE BONE GRAFT PUTTY
- K123552 — INSTINCT JAVA SYSTEM
- K123716 — AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT
- K130063 — ARCOS TROCHANTER BUTTON
- K130108 — DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS
- K130167 — PROFEMUR XM DISTAL CENTRALIZER
- K130269 — ECAT SCINTRON PET
- K130335 — MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX
- K130441 — FALLER STYLET
- K130489 — ELECTRODE, FLEXIBLE SUCTION COAGULATOR
- K121659 — BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
- K122199 — PREXION3D ECLIPSE
- K122200 — A3F FRATIONAL
- K122461 — RHYTHMIA MAPPING CATHETER
- K123280 — NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
- K123676 — CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
- K123900 — SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
- K124049 — DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
- K130100 — COMINED STANDARD SOLUTION
- K130152 — HYDRASOLVE LIPOPLASTY SYSTEM
- K130548 — EPICAGE INTERBODY FUSION DEVICE
- K130717 — ENDO GIA RELOAD
- K130770 — MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
- K130772 — MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR
- K130883 — SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
- K121770 — HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
- K122716 — PLASMATRODE SALINE SAFE TUR ELECTRODE
- K123083 — COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
- K123290 — M300 & M400
- K123467 — VS3
- K123593 — QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
- K123597 — TRUECPR COACHING DEVICE
- K123804 — INSTAFLO BOWEL CATHETER SYSTEM KIT
- K123945 — STRIVE DUAL ZONE PEAK FLOW METER
- K124009 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C
- K130007 — SLEEP PROFILER
- K130535 — IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
- K130725 — MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
- K130817 — LTN - LAPAROSCOPIC SURGICAL MESH
- K122823 — SIGN PEDIATRIC FIN NAIL
- K123045 — BRIGADE STANDALONE SYSTEM
- K130114 — PAINMASTER MCT PATCH
- K130718 — PEERSCOPE SYSTEM
- K122076 — PERSONAL HEALTH CENTER (PHC)
- K122304 — HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
- K123573 — YOULASER CO2 LASER
- K123621 — OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
- K123853 — VIVASIGHT-DL SYSTEM
- K123888 — Z CARTRIDGE IOL DELIVERY SYSTEM
- K123909 — AESCULAP CESPACE XP
- K130673 — LOSPA TOTAL KNEE REPLACEMENT SYSTEM
- K113439 — EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
- K122223 — NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
- K122418 — IOLMASTER 500
- K122464 — MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE
- K122537 — PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0
- K122994 — INTRAMEDULLARY NAIL SYSTEM
- K123387 — QUIKCLOT HEMOSTATIC DRESSING
- K123430 — MICROSLIDER TEARAWAY INTRODUCER SET
- K123935 — IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
- K130119 — PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
- K130677 — APTUS HELI-FX AORTIC SECUREMENT SYSTEM
- K130678 — BIOMARC GOLD FIDUCIAL MARKER
- K130761 — LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
- K130803 — UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM
- K130884 — XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
- K130929 — ZMED VP4000
- K122069 — STORM MINI SCREW
- K122239 — FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING
- K122455 — SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
- K122505 — SINGLE USE PRELOADED SPHINCTEROTOME V
- K122812 — JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
- K123293 — PASTELLE Q-SWITCHED ND: YAG LASER
- K123339 — TK1 TOTAL KNEE SYSTEM
- K123393 — HEALICOIL SUTURE ANCHOR WITH REGENESORB
- K123461 — STAXX(R) IB SYSTEM
- K123700 — FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
- K123777 — MULTILASER SYSTEM
- K130056 — PATIENT MONITOR
- K130120 — EXTREMITY MEDICAL IP FUSION SYSTEM
- K130121 — SHORT PORT BLUNT TIP TROCAR
- K130291 — S4 SPINAL SYSTEM
- K130306 — INCITE ANCHORED CERVICAL INTERBODY DEVICE
- K130465 — EPIC 10S
- K130711 — INFINITY CENTRALSTATION WITH INFINITY M300
- K130813 — MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
- K122470 — PENTAX EPK-I5010 VIDEO PROCESSOR
- K122996 — ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085
- K123703 — HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
- K123708 — SPINE COIL
- K123784 — STRAUMANN DENTAL IMPLANT SYSTEM
- K130637 — JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
- K130646 — CD HORIZON SPINAL SYSTEM
- K112996 — EUROIMMUN ANTI-ENA POOL ELISA (IGG)
Data sourced from openFDA. This site is unofficial and independent of the FDA.