FDA 510(k) clearances — page 754
clearances on record, most recent first.
Clearances — page 754
75,301–75,400 of 176,637- K022765 — NITRILE POWDER-FREE EXAMINATION GLOVES
- K022794 — E-SPEED EBT SCANNER SYSTEM
- K022810 — COBRASCAN CR-1 FILMLESS
- K022897 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
- K022940 — IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
- K023052 — ACUITY RADIATION THERAPY SIMULATOR
- K023061 — KONICA DIRECT DIGITIZER REGIUS, MODEL 170
- K023100 — ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
- K023130 — ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
- K023145 — VINYL EXAMINATION GLOVES, PRE-POWDERED
- K023164 — BBC-63-GE BREAST ARRAY COIL
- K023221 — CONTACT LASER & DIAGNOSTIC LENSES
- K022306 — AART SILICONE TUBING
- K022316 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K022797 — TWINKY STAR
- K020948 — SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
- K021238 — FRYE ADJUSTING INSTRUMENT
- K021329 — RITA SYSTEM
- K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
- K022321 — STOCKERT V172-28 VENOUS FEMORAL CANNULA
- K022342 — EZ-SCOPE AN, EZ-SCOPE LIGHT
- K022472 — PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
- K022489 — SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
- K022580 — BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
- K022581 — BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
- K022630 — MODIFICATION TO FOCUS
- K022665 — POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
- K022666 — PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
- K022743 — REPROCESSED DISPOSABLE TROCARS
- K022748 — REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
- K022785 — EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION
- K022811 — W-5
- K022826 — CLEAR-IT ANTI-FOG, MODEL PS003
- K022996 — VITA IN-CERAM YZ CUBES FOR CEREC
- K023102 — ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
- K023134 — JET-X TIN COATED HALF PINS
- K023170 — NITRILE POWDER-FREE EXAMINATION GLOVES
- K023207 — OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
- K023285 — DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
- K023294 — BOSWORTH CORACO-CLAVICULAR SCREW
- K023336 — OCO DENTAL IMPLANT (5.0MM DIAMETER)
- K020027 — FOCUS RADIATION TREATMENT PLANNING SYSTEM
- K020507 — OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
- K020670 — MODEL 4310 PSARRAY2 EEG ELECTRODE
- K021333 — ARTEMIS
- K021716 — SIMPLIFY COMPACT RESUSCITATOR
- K021955 — TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
- K022226 — ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS
- K022228 — FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES
- K022307 — KONRAD, MODEL V.2.0
- K022322 — INNOVA AND INNOVA 2000 S
- K022441 — STERRAD SEALSURE CHEMICAL INDICATOR TAPE
- K022495 — GETTIG DISPOSABLE SYRINGES
- K022565 — TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
- K022656 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
- K022781 — MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
- K022946 — LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
- K023032 — LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
- K022219 — EXOMIO, MODEL 1.1
- K022299 — TRILUX, Z-TONE, ACRY ROCK
- K022373 — CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
- K022734 — PULPDENT CALCIUM HYDROXIDE PREPARATION
- K012271 — ACUTEVENTILATOR
- K012344 — VANGUARD REPROCESSED PULSE OXIMETER SENSORS
- K013525 — CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)
- K014128 — CANDELA SMOOTHBEAM LASER SYSTEM
- K020671 — PSA4000 EEG MONITOR WITH FRONTAL PSI
- K021390 — PMX COMPACT RESUCITATOR
- K021788 — NBD CEMENT RESTRICTOR DEVICE
- K022207 — AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
- K022210 — MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650
- K022257 — VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX
- K022276 — KOKOMATE
- K022311 — RHINOSTREAM RHINOMANOMETER MODULE
- K022382 — RHS ACETABULAR COMPONENT
- K023021 — MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
- K023022 — NUGEN FX SCREW
- K023049 — SYNCHRON LX I 725 CLINICAL SYSTEM
- K023086 — CLASSIC GREAT TOE IMPLANT
- K023124 — CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
- K020334 — INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC
- K020810 — VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
- K022188 — RADIANALYZER, MODEL 12710
- K022205 — DISPOSABLE N-PE MICROKERATOME BLADES
- K022234 — ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
- K022266 — AURORA SR
- K022300 — ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V
- K022475 — MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS
- K022485 — DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
- K022808 — DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
- K022896 — CSV12 SOFTWARE VIEWER
- K022904 — DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
- K022910 — QSC-63-INT SHOULDER ARRAY COIL SET
- K022939 — OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
- K023053 — DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
- K011208 — BIOVER
- K022199 — ENDIUS ATAVI SYSTEM
- K022264 — CLEAN 'N' OIL
- K022265 — LIGHT TIP
- K022641 — TOKUYAMA REBASE II
Data sourced from openFDA. This site is unofficial and independent of the FDA.