FDA 510(k) clearances — page 619
clearances on record, most recent first.
Clearances — page 619
61,801–61,900 of 176,637- K062716 — ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400
- K062735 — TUTU 7, MODEL IV-T22
- K062778 — STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
- K062860 — MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A
- K063065 — MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)
- K063107 — 3DNET SUITE
- K063113 — EP-WORKMATE
- K052055 — SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
- K061700 — NEOTRACT ANCHOR
- K061725 — STRYKER ARIA PNEUMATIC SYSTEM
- K061899 — EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
- K062260 — OSTEOBOOST-BMA
- K062375 — MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
- K062471 — ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
- K062699 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
- K062700 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
- K062783 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K062887 — MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F
- K063053 — MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)
- K063064 — MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)
- K063110 — CST61 HIGH SPEED TURBINE HANDPIECE
- K052944 — AMBU WHITE SENSOR CFM, CFL
- K053550 — AMBU BLUE SENSOR NEO AND NEO X
- K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
- K060615 — CD HORIZON SPINAL SYSTEM
- K061342 — MALIBU SPINAL SYSTEM
- K061416 — SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74
- K062103 — DARCO FORCE TITANIUM COMPRESSION SCREW
- K062292 — UNICEM
- K062338 — TELEVISIT
- K062461 — C. ALBICANS PNA FISH
- K062498 — PROFYLE SYSTEM
- K062732 — TOMAS PIN 6 MM
- K060653 — THERMACLEAR
- K060971 — OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS
- K061878 — ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC
- K062143 — KOZY COMFORT INFANT POSITIONER
- K062148 — DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
- K062660 — CATALYSY
- K062665 — INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
- K062672 — GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
- K062687 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML
- K062853 — MODIFICATION TO STRYKER SPINE OASYS SYSTEM
- K062888 — MIDDLE WHEEL DRIVE POWER CHAIR, CWD01
- K063078 — MICROENDOSCOPE
- K060414 — KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
- K061188 — SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- K061754 — BARD COMPOSITE L/P MESH
- K062361 — INNOVACON HCG UKTRA TEST DEVICE
- K062446 — MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
- K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
- K062916 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
- K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
- K062129 — P.0004 IMPLANTS
- K062147 — INTEGRA SL
- K062156 — SUPER ORTHODONTIC SCREW
- K062202 — OCCLUSION BALLOON
- K062251 — REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
- K062295 — IRI INTEGRATED RETINAL IMAGER
- K062450 — D-SPECT CARDIAC SCANNER SYSTEM
- K062647 — E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
- K062695 — SAGEMAX Z-BLANK
- K062705 — SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID
- K062722 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K062830 — BIOLUCENT APPLICATOR KIT
- K062832 — VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
- K062858 — MODIFICATION TO GLIDESHEATH
- K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03
- K062882 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
- K062903 — SBI CARPAL FUSION PLATE
- K060967 — NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
- K061681 — REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
- K061863 — ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
- K062079 — XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
- K062125 — SUPERSTITCH 5F, 12F, AND EL
- K062336 — OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE
- K062352 — FRS SCREW
- K062418 — K-SPRAY, MODEL 085-2715
- K062494 — EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
- K062496 — OSTEOPORE TCP
- K062519 — NEXUS 3
- K062564 — SYNTHES LCP DISTAL FEMUR PLATES
- K062774 — BELMONT BUDDY PLUS FLUID WARMER
- K062831 — MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
- K063047 — MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
- K060204 — LIAISON EA IGG
- K061359 — DENSHIELD TREATMENT FOR SENSITIVE TEETH
- K061411 — TORBOT VASCULAR COMPRESSION GARMENTS
- K061549 — AMNIOSTAT-FLM-PG
- K061661 — STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
- K061842 — QUANTA LITE PBC SCREEN IGG/IGA ELISA
- K062005 — PORTEX EPIDURAL CATHETER
- K062080 — RESUSCITATION TIMER, MODEL L770-CPR
- K062090 — PRISMA SYSTEM R03.10A
- K062268 — MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
- K062305 — CLARITY MODIFIED CERAMIC BRACKETS
- K062540 — NASOPORE EAR, MODELS ND04, ND05
- K062786 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K062809 — ADMIRAL XTREME PTA CATHETER
- K062864 — MASTALEX -MRSA, MODEL RST501
Data sourced from openFDA. This site is unofficial and independent of the FDA.