FDA 510(k) clearances — page 530
clearances on record, most recent first.
Clearances — page 530
52,901–53,000 of 176,542- K091220 — HEALTHANYWHERE SYSTEM
- K091553 — BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE
- K091647 — INJECTAFIL
- K091853 — WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
- K091870 — TORNIER, PITON FIXATION IMPLANT SYSTEM
- K091883 — T2 SPINAL SYSTEM
- K091942 — POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES
- K092051 — THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
- K092130 — RASCAL WE GO 250 POWERED WHEELCHAIR
- K092154 — HEARTWAY POWER MOBILITY SCOOTER, S9
- K092155 — HEARTWAY POWER MOBILITY SCOOTER, S8
- K092327 — MICRO-TOUCH NITRA FREE
- K092758 — X-CUBE
- K082118 — XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
- K090216 — COLLAGEN DENTAL MEMBRANE IV
- K090429 — NUNC IVF CENTERWELL AND ICSI DISHES
- K090449 — MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
- K090450 — MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
- K090742 — DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
- K090773 — CFI ULTRASOUND PROBE DRAPE
- K090810 — THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
- K090855 — EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE
- K091122 — DIANA FUSION CAGE
- K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
- K091534 — LIGHTLAS MODEL 532
- K091559 — MARKSMANN CATHETER
- K091759 — SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
- K091873 — TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S
- K091887 — LED CURING LIGHT, MODEL GT-1500
- K091898 — BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
- K091999 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K092000 — POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
- K092018 — OMNIPRO INCLINE
- K092067 — ABVS WORKPLACE
- K092100 — POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
- K092145 — 160MLC OPTION
- K092189 — POGO SCREW
- K092496 — COPRAN ZR/ORIGIN YZ
- K092562 — MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
- K092653 — VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
- K092719 — DIGITAL BLOOD PRESSURE MONITOR
- K091608 — COBALT MV BONE CEMENT
- K091731 — AMSCO EVOLUTION MEDIUM STEAM STERILIZER
- K092716 — ESOPHAGEAL STETHOSCOPE
- K083817 — M. DIOR BRAND
- K091202 — WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,
- K091953 — PRO-PICC
- K092200 — POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
- K092319 — STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387
- K092347 — PRO-PICC CT
- K092416 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K092506 — EASYRA GLU-H REAGENT, MODEL 10200
- K092594 — ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX
- K081996 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
- K083715 — BELTBEAT WF-400
- K091117 — ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
- K091350 — ESTECH HAWKEYE INTRODUCER SYSTEMS
- K092019 — MODEL 1014 PC ELECTROMETER
- K092134 — STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)
- K092304 — ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES
- K092533 — FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES
- K092577 — ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
- K092698 — QUICKVUE INFLUENZA A+B TEST
- K083567 — GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW
- K090174 — TSI; ERI
- K091135 — RUTTER SUPRA STOMAL STENTS
- K091187 — GRACE DYNAMIC TORP
- K091488 — FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C
- K091638 — DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
- K091968 — KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
- K092128 — MODIFICATION TO: PSS SYSTEM
- DEN080006 — ULTHERA SYSTEM, MODEL 8850-0001
- DEN090004 — OVA1 TEST
- K082811 — URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
- K083536 — DENSICHEK PLUS
- K083679 — UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
- K083783 — VF LIQUIGEL
- K090911 — IST SNORING APPLIANCE
- K091171 — D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
- K091223 — VALLEYLAB SUCTION COAGULATOR, MODEL E3305
- K091321 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
- K091508 — ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM
- K091799 — CABLE READY CABLE GRIP SYSTEM CABLE BUTTON
- K092372 — HEARTRAIL III GUIDING CATHETER
- K092497 — SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
- K092553 — TRU FLU, MODEL 751230
- K092612 — D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505
- K090175 — UNITY BETA PLLA SYSTEM
- K091614 — OSTEOMED FOOT PLATING SYSTEM
- K091808 — SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
- K091843 — COMFORT TWIN NASAL MASK
- K091852 — BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205
- K091943 — POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
- K092635 — ALCATEL-LUCENT TELEHEATH MANAGER
- K082841 — SPINAL FORAMINOSCOPE
- K090104 — LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
- K091544 — S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
- K091937 — OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
- K092237 — NSM-S15 SYSTEM
- K092441 — MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.