FDA 510(k) clearances — page 449
clearances on record, most recent first.
Clearances — page 449
44,801–44,900 of 175,770- K120115 — ORTHOSIZE
- K120439 — BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
- K103116 — AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
- K103329 — DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
- K111523 — OSTEOCOOL (TM) RF ABLATION SYSTEM
- K112144 — AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS
- K112561 — NUVASIVE COROENT NO-PROFILE SYSTEM
- K112648 — ASFORA BULLET CAGE
- K113157 — AILERON INTERSPINOUS FIXATION SYSTEM
- K113354 — VETA PERITONEAL DIALYSIS CATHETER
- K113688 — MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
- K110662 — ADAPTIVE WEDGE
- K111663 — TRAUMA INTERNAL FIXATION SYSTEMS
- K112663 — ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL
- K112757 — PIONEER POSTERIOR CERVICO THORACIC SYSTEM
- K113429 — SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
- K113540 — RELIANCE LUMBAR IBF SYSTEM
- K113624 — WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
- K113838 — WILDCAT CATHETER
- K113860 — VISUAL-ICE CRYOABLATION SYSTEM
- K110761 — MICT TSH
- K112077 — HBIDB - HUMAN BRIAN INDEX SOFTWARE
- K112638 — NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
- K112659 — SURGICAL RETRACTORS
- K112802 — PIPELINE TOTAL HIP SYSTEM
- K113260 — MODIFIED CONCENTIRC MICROCATHETER
- K113413 — ASCEND SHOULDER SYSTEM
- K113423 — KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
- K113487 — HEMO-CATH 10F, HEMO-CATH 12.5F
- K120233 — SYNCHRONY RESPIRATORY TRACKING SYSTEM
- K120380 — SATURN 8000
- K120399 — LANX SPINAL FIXATION SYSTEM
- K120525 — QLAB QUANTIFICATION SOFTWARE
- K113082 — SONOVISION
- K113131 — LIASYS 450
- K113151 — IFS LASER SYSTEM
- K113810 — MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
- K113822 — QUADRASPHERE 30 TO 60
- K113872 — THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
- K120044 — ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED
- K120434 — POWER ADAPTOR INSTRUMENT ACCESSORY
- K120526 — YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR
- K113255 — PUREGRAFT 850/PURE SYSTEM
- K113284 — BIOPSY POSITIONER
- K113372 — NUVANT, MOBILC CARDIAC TELEMETRY
- K113575 — HILLA DIGITAL TRANSFERS
- K113807 — DEXERYL CREAM
- K120109 — SUPER SEAL TOOTH DESENSITIZER
- K120355 — LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM
- K111268 — CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
- K112547 — NEO NEST
- K112606 — ACTIVATOR V-E
- K113274 — FOOTPRINT ULTRA PK SUTURE ANCHOR
- K113356 — HOLOGIC VISCERAL FAT SOFTWARE
- K113464 — NC TREK OTW CORONARY DILATATION CATHETER
- K113686 — KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED
- K113790 — DISPOSABLE VINYL EXAM GLOVE, POWDERED
- K113832 — SONICEYE ULTRASOUND TRANSDUCER
- K120124 — FORESIGHT U120 URINE ANALYZER
- K120254 — THERASAGE HEATING PAD
- K120318 — VIVI ERGON-X HF
- K120358 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K120505 — FRESENIUS 2008T HEMODIALYSIS MACHINE
- K110901 — SYMBIQ INFUSION AND ADMINSTRATION SET
- K111792 — MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI
- K111869 — VIRTUOSO SYSTEM FOR IHC PR (IE2)
- K113422 — TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE
- K113478 — PLIF CAGE
- K113655 — TI-MAX X TURBINE
- K113711 — LIME-LITE II
- K113750 — DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR
- K103081 — COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
- K110745 — HELICOBACTER PYLORI ELISA IGG TEST KIT
- K111423 — CS 1600 INTRAORAL CAMERA
- K111544 — GLIDER PTCA BALLOON CATHETER
- K111670 — VENUS FREEZE (MP)2 SYSTEM
- K111964 — AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
- K113095 — E-CARE INFRARED EAR THERMOMETER
- K113097 — LASER HELMET
- K113264 — ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
- K113297 — KNOTILUS ANCHOR SYSTEM
- K113455 — SOLITAIRE FR REVASCULARIZATION DEVICE
- K113584 — PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
- K113594 — C-THV SYSTEM
- K113617 — SPEE-DEE PATCH
- K113784 — 3MP MONOCHROME LCD MONITOR, RADIFORCE GX340
- K113797 — DISPOSABLE VINYL EXAM GLOVE, POWDER FREE
- K120274 — DELTAMAXX 18 MICROCOIL SYSTEM
- K111426 — EUCLID (TM) TIER 1-GW ACCESS SYSTEM
- K111654 — FD TENS 2070
- K111841 — SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
- K111947 — DUET MAGNA
- K112133 — OASYS SURGICAL LIGHT CONTROLLER
- K112507 — RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
- K112568 — AONGEN DENTAL COLLAGEN MATRIX
- K112769 — CURAD COMPRESSION HOSIERY
- K113003 — ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
- K113037 — PAIN-AID
- K113188 — SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
- K113232 — MAXMIXING BLOCK
Data sourced from openFDA. This site is unofficial and independent of the FDA.