FDA 510(k) clearances — page 434
clearances on record, most recent first.
Clearances — page 434
43,301–43,400 of 175,770- K121251 — ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK
- K121257 — LARYNGEAL ELECTRODE
- K121400 — PAX-UNI3D, PHT-7500
- K121482 — INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
- K122027 — ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
- K122249 — TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE
- K122296 — SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
- K122297 — ENLUXTRA HUMIFIBER WOUND DRESSING
- K122323 — DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
- K122359 — VITEK 2 STRPTOCOCCUS CEFTRIAXONE
- K122528 — ULTHERA SYSTEM
- K120997 — BAROSTAT SOFTWARE OPTION
- K121264 — TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
- K121542 — PICIS WEIGHT BASED DOSE CONVERTER
- K122302 — ACE MAGNESIUM REGENT
- K110954 — ARJORAD STERILE WRAP
- K113747 — RANDOX OPIATES ASSAY
- K120169 — INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
- K120239 — ELEVANCE
- K120906 — ZIMMER TRABECULAR METAL TOTAL ANKLE
- K121103 — LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S
- K121329 — AIXPLORER
- K121619 — NUVASIVE POLYAXIAL SPINAL SCREWS
- K121820 — INWAVE
- K121892 — PHANTOM PLUS CERAMIC CAGE SYSTEM
- K121895 — ELECSYS HSV-2 IGG IMMUNOASSAY
- K122254 — INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
- K111603 — LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
- K113552 — FREEDOM INGUINAL HERNIA IMPLANT
- K120004 — (MULTIPLE) DIGITAL THERMOMETER
- K120991 — TRANS1 INTERBODY FUSION SYSTEM
- K121089 — NMI PICC III
- K121324 — AVT NATURASOFT
- K121502 — SYNTHES CURVILINEAR DISTRACTION SYSTEM
- K121611 — AMPLATZER TORQVUE FX
- K121690 — ETCHONIA ZERONA ARMS
- K121695 — ERCHONIA ZERONA
- K121824 — ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2
- K122086 — THERMAL LIGATING SHEARS
- K122244 — POLARCUP DUAL MOBILITY SYSTEM
- K120626 — EON CALCIUM REGENT
- K121140 — PROLYTE ELECTROLYTE ANALYZER
- K121181 — SWANNSHIDI BONE MARROW ASPIRATION NEEDLE
- K121185 — EDWARDS PERCUTANEOUS SHEATH INTRODUCER
- K121304 — OSTEOMED CRANIAL DISTRACTION SYSTEM
- K121536 — INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
- K121550 — HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY
- K121854 — SYSTEM, X-RAY, STATIONARY
- K121890 — GENESYS PRESSFT SUTURE ANCHOR
- K121943 — XPRESS MULTI-SINUS DILATION TOOL
- K122083 — ELITECH CLINICAL SYSTEMS CK NAC SL
- K111627 — SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K111914 — VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
- K112916 — TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM
- K113062 — ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES
- K113312 — HY-CHLO(TM)WOUND SCRUB
- K113568 — MTA-FILLAPEX
- K120921 — CLEVER CHOICE
- K121063 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM
- K121485 — GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
- K121764 — CD HORIZON SPINAL SYSTEM
- K122240 — BONE PLUS BCP EAGLE EYE
- K111460 — OPTO HYALUS GREEN LASER
- K120486 — AVS AS PEEK SPACER
- K120500 — THE PAIN PILOT (A.K.A PAIN PILOT)
- K120835 — DYNATRON THERMOSTIM PROBE-DONE
- K121148 — SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D
- K121154 — ULTRASONIC NEBULIZER
- K121452 — GRIDLOCK PLATING SYSTEM
- K121720 — WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
- K122179 — VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE)
- K112373 — CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION
- K113128 — MICROAIRE SURGICAL INSTRUMENTS LLC
- K113715 — LUNG VOLUME ANALYSIS
- K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
- K120008 — MEDLINE HIGH PRESSURE INJECTION TUBING
- K120030 — TAPERLOC COMPLETE SIZE 4MM AND XR 123
- K120151 — NEBULAE I
- K120890 — POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
- K121025 — YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION
- K121062 — VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
- K121176 — STGC
- K121497 — VENOFER PUMP
- K121718 — A-V FOOT PUMP
- K121910 — OCTAVE SPEEDER HEAD
- K121911 — OCTAVE SPEEDER SPINE
- K122138 — ATRIUM FLIXENE IFG VASCULAR GRAFT
- K122145 — LANX SPINAL FIXATION SYSTEM
- K122190 — PRELUDE 7F SHORT SHEATH INTRODUCER
- K122203 — TRUETOME
- K120398 — WITOUCH PRO
- K120986 — STRATIFY JCV DXSELECT
- K121095 — DX-D IMAGING PACKAGE
- K121173 — CHORD-X EPTFE SUTURE
- K121422 — APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM
- K121548 — SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
- K121855 — RESPROCESSED SERFAS ENERGY PROBE
- K121863 — VITEK 2 AST-ST CEFOTAXIME
- K122182 — DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
- K122234 — OEC 9900 ELITE
Data sourced from openFDA. This site is unofficial and independent of the FDA.