FDA 510(k) clearances — page 669
clearances on record, most recent first.
Clearances — page 669
66,801–66,900 of 175,825- K043397 — MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE
- K043481 — MODIFICATION TO: ZILVER 635 BILIARY STENT
- K043561 — MODIFICATION TO VERTE-STACK SPINAL SYSTEM
- K042381 — CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
- K042478 — CAPSULE TENSION RING INSERTER, MODEL 7-810
- K042930 — SPACEVISION CAGE SYSTEM
- K043343 — MODIFICATION TO: CD HORIZON SPINAL SYSTEM
- K043403 — CEMEX SYSTEM GENTA FAST BONE CEMENT
- K032434 — CLINICAL ELECTRONIC THERMOMETER
- K040972 — CALCIUM, AZO DYE REAGENT
- K040973 — BUN REAGENT
- K040974 — GLUCOSE OXIDASE, GLUCOSE
- K040975 — GENCHEM CO2 ACID REAGENT
- K040976 — GENCHEM CREATININE REAGENT
- K040977 — GENCHEM ELECTROLYTE BUFFER
- K042288 — UNICRYL
- K042329 — SALICYLATE-SL ASSAY
- K042362 — MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
- K042902 — HERBERT ULNAR HEAD PROSTHESIS SYSTEM
- K042911 — CEMENTEK LV
- K042947 — PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
- K043404 — MODIFICATION TO T2 PROXIMAL HUMERAL NAIL
- DEN040011 — AMPLICHIP CYP450 TEST, MODEL 04381866190
- DEN040012 — AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
- K030295 — LTU-904 PORTABLE LASER THERAPY UNIT
- K040778 — TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
- K041078 — SURGPLAN AND PANPLAN
- K041757 — FEMSPEC DISPOSABLE VAGINAL SPECULUM
- K042038 — MTF ALLOGRAFT ANCHOR
- K042620 — SONATA 3-D IMAGING ACCESSORY, MODEL 3DS
- K042985 — LIFESTENT NT35 BILIARY STENT SYSTEM
- K043086 — SOMATOM RESPIRATORY GATING
- K043090 — EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
- K043202 — OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
- K043237 — VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
- K043241 — LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
- K043276 — DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
- K043318 — MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
- K043381 — INFINIA LIGHTSPEED
- K030400 — NEOSCI MEDICAL ENDOLUMINAL BRUSH
- K033559 — 12-LEAD GLOVE
- K040971 — GENCHEM ISE ELECTROLYTE REFERENCE
- K042603 — GYNECARE PROLENE FASTENER SYSTEM
- K042631 — EAR THERMOMETER, MODEL WL-320X
- K042732 — ARCHITECT CA 15-3 ASSAY
- K042760 — PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
- K042762 — PEFAKIT APC-R FACTOR V LEIDEN
- K042822 — TCM ENDO V, MODEL 1534
- K042907 — NEEDLE INCAPACITATOR (NEEDLE GUARD)
- K042959 — DEPUY C-STEM AMT HIP PROSTHESIS
- K042982 — QUANTEX MYOGLOBIN
- K043038 — BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
- K043056 — GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
- K043076 — GE OEC FLUOROSTAR
- K043081 — GORE POLYPROPYLENE HERNIA MESH
- K043158 — ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
- K043184 — HEMOSIL RECOMBIPLASTIN
- K043239 — HEALTHSTAR ELITE
- K043247 — DUCERA ALLCERAM
- K043269 — Lysus Infusion System
- K043272 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
- K043311 — ASCENSIA ELITE DIABETES CARE SYSTEM
- K033044 — DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
- K040487 — TRABECULAR METAL KNEE SYSTEM AUGMENTS
- K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
- K041810 — SERFAS ENERGY SYSTEM
- K041850 — MEDALLION MODULAR HIP SYSTEM
- K041950 — APEX K2 HIP SYSTEM
- K042000 — MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS
- K042132 — NOVASYS TRANSURETHRAL RF SYSTEM
- K042666 — LUTH-ALL SUB-Q NEEDLE SET
- K042789 — VERTEX RECONSTRUCTION SYSTEM
- K042825 — ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
- K042841 — M2A/C2A ACETABULAR SYSTEM
- K042871 — TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3
- K042979 — MODIFICATION TO: PLEXALONG SETS
- K043128 — OLYMPUS ENDOARM
- K043130 — MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
- K043132 — UNIVERSAL XACTTRACE
- K043229 — MODIFICATION TO ALTIUS OCT SYSTEM
- K043232 — UCR SPINAL SYSTEM
- K043280 — MIMIX MP BONE VOID FILLER
- K043291 — CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
- K043452 — TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM
- K043455 — SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM
- K043482 — THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
- K041658 — BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
- K042079 — OSS/(SCARF)- AND OSW-SCREW
- K042846 — SYSTEMP.LINK
- K043085 — MODIFICATION TO: PNEUTON VENTILATOR
- K043159 — POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
- K043221 — WILLI GELLER CREATION CP PORCELAIN
- K043244 — FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
- K043412 — MODIFICATION TO: VIEWSTATION
- K040047 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
- K040049 — THE RELIANCE ENDOSCOPE PROCESSING SYSTEM
- K040426 — TRANS1 AXIAL FIXATION SYSTEM
- K040592 — CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
- K041619 — BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
- K041987 — CORTRAK
Data sourced from openFDA. This site is unofficial and independent of the FDA.