FDA 510(k) clearances — page 698
clearances on record, most recent first.
Clearances — page 698
69,701–69,800 of 175,825- K032555 — 3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316
- K032625 — ORTHODONTIC COMPOSITE BRACKET SYSTEM
- K033086 — NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE
- K033479 — PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
- K033689 — OSSTELL MENTOR RFA
- K040184 — DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
- K040201 — MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
- K040252 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT
- K033053 — ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
- K033232 — COLORADO MICRODISSECTION NEEDLE
- K033259 — LIGHT AGE Q-CLEAR LASER, MODEL 701-1101
- K033352 — VERTEBRON PSS PEDICLE SCREW SYSTEM
- K033395 — CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1
- K033717 — TRANSET FRACTURE FIXATION SYSTEM
- K033940 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
- K033981 — SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
- K033988 — GOLDWAY UT4000A VITAL SIGNS MONITOR
- K040157 — ELECSYS C-PEPTIDE CALCHECK
- K040183 — BISX
- K040214 — MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K040326 — AUTOQUANT PLUS
- K032888 — CREATION NM DIAGNOSTIC CATHETERS
- K033030 — CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
- K033564 — POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2
- K033650 — ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
- K033723 — DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES
- K033767 — DUAL TOP ANCHOR SYSTEM SCREWS
- K033996 — HERMES
- K040176 — MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
- K040219 — COBRA SURGICAL PROBE
- K040249 — SKINTACT ECG ELECTRODE
- K040305 — VITREA2 VERSION 3.5
- K040309 — DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862
- K033678 — SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038
- K033724 — NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236
- K033749 — TITANIUM CANNULATED INTERFERENCE SCREW
- K033812 — SIROAIR L AIR SCALER
- K033820 — MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1
- K040091 — LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
- K040166 — DEPUY SIGMA XLK TIBIAL INSERTS
- K040272 — SYNTHES (USA) CRANIOFACIAL PLATES
- K031051 — SMARTEP-ASSR, MODEL M811007
- K031774 — HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES
- K032056 — BILEVEL CPAP, MODEL 9055 SERIES
- K032064 — THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
- K032350 — INFRARED SCIENCES BREASTSCAN IR SYSTEM
- K032394 — STRYKER SPINE OASYS SYSTEM
- K032443 — DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
- K032979 — PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
- K033466 — COLOR LCD DISPLAY, MODEL RADIFORCE R22
- K033676 — PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER
- K033677 — BRAIN PERFUSION OPTION
- K033690 — TROPHYPAN AND TROPHYPAN C
- K033700 — MAMMOTOME EX HAND HELD SYSTEM
- K033731 — AXSYM CORTISOL ASSAY
- K033805 — SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
- K033806 — ACE PROXIMAL HUMERAL NAIL SYSTEM
- K033809 — DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
- K033821 — KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
- K033878 — ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM
- K033950 — DORC VITRECTOMY LENSES, MODEL 1284 SERIES
- K033962 — LAD (EPITURE EASYTOUCH), MODEL LAD-08
- K033968 — HANSSON PIN SYSTEM
- K034015 — EARLOOP PROCEDURE MASK
- K034054 — PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
- K040137 — WILSON-COOK USW CAP AND WIRE LOCK
- K040151 — OASIS BILIARY STENT INTRODUCTION SYSTEM
- K040199 — OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS
- K040212 — TRIGEN INTERTAN
- K040221 — SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
- K040251 — GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587
- K040319 — SINON POWER WHEELCHAIR, SN-W401
- K032551 — MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR
- K032612 — IR FOREHEAD THERMOMETER, MODEL HV-T36
- K033296 — MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
- K033759 — C2 NASAL MASK
- K034010 — GELSOFT PLUS ERS
- K040254 — INTEGRIS 3D-RA, RELEASE 4.2
- K031859 — CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
- K033205 — MANOA BREAST BIOPSY SYSTEM
- K033223 — ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
- K033354 — FEMTEC LASER MICROKERATOME
- K033517 — SPINAL CONCEPTS INC. CADENCE AND TRAXIS
- K033633 — VASCON POLARIS GUIDING CATHETER
- K033978 — ADAM
- K034039 — SIS PLASTIC SURGERY MATRIX
- K040020 — C.T.M. POWER CHAIR, MODEL HS-1000
- K040104 — COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0
- K040113 — SANDMAN SD20 AMPLIFIER
- K040139 — ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER
- K040150 — MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
- K040167 — VERTE-STACK SPINAL SYSTEM
- K023651 — VECTORVISION CRANIAL/ENT
- K032903 — ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
- K032958 — PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
- K033047 — ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE
- K033768 — ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
- K033909 — WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
- K040227 — QLAB QUANTIFICATION SOFTWARE
- K040239 — SUPRAFLOW CONSOLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.