FDA 510(k) clearances — page 780
clearances on record, most recent first.
Clearances — page 780
77,901–78,000 of 175,825- K013531 — QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
- K010739 — WATCH-PAT 100
- K010868 — PSYCHEMEDICS RIA COCAINE ASSAY
- K011195 — PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
- K011861 — BERNOULLI VENTILATOR MANAGEMENT SYSTEM
- K011899 — PF 5050 PRESSURE UNIT, MODEL PF 5050
- K012429 — SURESET INFUSION SET, MODEL 8023
- K012617 — JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
- K013316 — SICKLE-CHEX
- K013496 — MODIFICATION TO SKYLIGHT IMAGING SYSTEM
- K002937 — TST CONTROL INTEGRATOR FOR STEAM STERILIZERS
- K011788 — EVERSTICK
- K011799 — EVERSTICKNET
- K012396 — ONTRAK TESTCARD 9
- K012545 — ARAMIS DERMATLOGIC LASER
- K012552 — SCITON IMAGE HAIR REMOVAL LASER
- K012794 — PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
- K012942 — THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
- K011439 — MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
- K011933 — GLYCOSAL II HBA 1C TEST
- K011985 — SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
- K012147 — DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
- K012492 — KADANCE 2000
- K012531 — DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
- K012536 — REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
- K012546 — OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
- K012563 — DEEP GRAY
- K012591 — ADVANCE UNICONDYLAR KNEE SYSTEM
- K012626 — OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR
- K012779 — ICONNECTION 3D
- K012829 — STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
- K012843 — PORTADUR P 2, MODEL #2031
- K012921 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K012977 — VARICES INJECTION NEEDLE
- K013306 — MINIME NASAL MASK, MODEL P/N 50220
- K013326 — MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
- K013373 — OMNI C ANALYZER
- K013481 — DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
- K003957 — DIACLEAR ULTRAFILTER
- K011175 — W.O.M. LASER U100
- K011796 — RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION
- K012304 — ADC 656 ELECTRONIC STETHOSCOPE
- K012498 — DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM
- K012517 — CEREC3 VITABLOCKS
- K012527 — KSEA SIALOENDOSCOPES AND ACCESSORIES
- K012761 — PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
- K012767 — S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
- K012826 — BIOPORTA G, MODEL 2052
- K012827 — PORTA AURIUM, MODEL 2067
- K012828 — PORTA SMK 82, MODEL 2032
- K012831 — BIO PORTADUR, ORDER-NO.:2017
- K012834 — PORTA GEO TI MODEL #2004
- K012835 — PORTA MAXIMUM, MODEL# 2066
- K010202 — OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES
- K011221 — PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
- K011761 — MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT
- K011916 — SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
- K012495 — OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
- K012714 — ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
- K013504 — MODIFICATION TO: ECAT LSO PET/CT SCANNER
- K010586 — PALAMED BONE CEMENT
- K011265 — ULTRASOUND TRANSDUCER COVER
- K011476 — SOVEREIGN
- K012497 — CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
- K012532 — SEPRAGEL SINUS
- K012695 — VANGUARD REPROCESSED ARTHROSCOPIC WANDS
- K012895 — HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
- K013175 — TM2000 EASYTRACE PLUS RECEIVING CENTER
- K013257 — HEMI-ARC SURGICAL NAVIGATOR
- K013395 — LIFEJET VIDEO LINK
- K013422 — CARDIQ FUNCTION
- K011248 — CW DISPOSABLE ACUPUNCTURE NEEDLE
- K012145 — MICROPLEX COIL SYSTEM
- K012462 — THEKEN LARGE CEMENT RESTRICTOR
- K012465 — MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
- K012643 — APEX MEDICAL LCD TENS-VII
- K012868 — MICROMEDICS FIBRIJET AEROSOL APPLICATOR
- K013198 — FUJI VII CAPSULE
- K013336 — XANTALGIN CRONO
- K013375 — BELLEGLASS HP OPAQUE 2
- K013458 — CRANIAL HELMET
- K001509 — STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
- K003229 — BIOPATCH ANTIMICROBIAL DRESSING
- K010532 — OSTEOSET BVF KIT
- K010729 — AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
- K011365 — VITALSAT PULSE OXIMETER, MODEL IC32000
- K011913 — SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
- K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B
- K012416 — CONFOSCAN 2 CONFOCAL MICROSCOPE
- K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
- K012450 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
- K012628 — GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
- K012632 — TOURNIQUET CUFF; PNEUMATIC TOURNIQUET
- K012636 — BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
- K012809 — SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45
- K012859 — NU-SPEC D
- K013250 — GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
- K013348 — MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
- K013355 — SPARC SLING SYSTEM
- K013381 — ADVANCED LUNG ANALYSIS-1
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