FDA 510(k) clearances — page 573
clearances on record, most recent first.
Clearances — page 573
57,201–57,300 of 176,542- K080925 — FOX PLUS PTA CATHETER
- K070109 — NEUROMETRIX ADVANCE
- K071552 — PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
- K072932 — INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5
- K073356 — PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
- K073358 — LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A
- K073404 — IFS LASER SYSTEM
- K073600 — COMFORTGEL FULL FACE MASK
- K080141 — PC ECG 1200W SYSTEM
- K080151 — ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
- K080408 — EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD
- K080690 — MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
- K080743 — LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP
- K080760 — ACUSON X300 ULTRASOUND SYSTEM
- K080956 — MODIFICATION TO VF GEL PLUS
- K081018 — SYNGO DYNAMICS VERSION 7.0
- K081028 — SIGNA 3.0T MR750 SYSTEM
- K072206 — ERCHONIA EML LASER
- K072722 — MEDDORNA WIRELESS PRN SPIROMETER 100
- K072799 — TARGET STERILE ELECTRODE
- K072923 — ZOLL E SERIES DEFIBRILLATOR
- K073291 — CAPSTONE SPINAL SYSTEM
- K073440 — FOUNDATION CAGE
- K073447 — SURGI GLOVES
- K073640 — ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
- K080005 — SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701
- K080235 — SAFETY INFUSION SET
- K080627 — PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
- K080838 — ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
- K080865 — FAST1 INTRAOSSEOUS INFUSION SYSTEM
- K080883 — CR-1
- K073547 — ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL
- K073610 — ELTA ADVANCED WOUND WASH
- K073715 — ELIPO
- K080174 — PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C
- K080232 — ZOLL E SERIES 12SL, ANALYSIS OPTION
- K080248 — SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES
- K080274 — AMBULO 2400
- K080315 — DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
- K080335 — TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
- K080358 — PLLA, HA SCREW
- K080425 — CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
- K080472 — SEDAT MYSHELL LITE
- K080524 — CENTURION SORBAVIEW OTC
- K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
- K080815 — TOSCA II ANTERIOR CERVICAL PLATE SYSTEM
- K080918 — DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0
- K080943 — SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
- K080985 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
- K072061 — MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
- K072728 — SYNGO MULTIMODALITY WORKPLACE
- K073166 — ENDOWAVE INFUSION SYSTEM
- K073187 — PERIPHERAL NERVE BLOCK SUPPORT TRAY
- K080162 — UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
- K080351 — DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI
- K080686 — WESTCON HORIZON 49% (HIOXIFILCON B)
- K080821 — MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
- K072064 — GRAVILAX TRACTION SYSTEM
- K072613 — DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE
- K072811 — MARIONETTE SA, MODEL 001 001 & 001 002
- K080084 — CELL GEN LASER, MODEL CG-4000
- K080338 — CUTTERSIL ACTIVATOR UNIVERSAL PLUS
- K080361 — REGENEREX TIBIAL COMPONENTS
- K080501 — SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240
- K080507 — AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
- K080511 — PLEXUR-P
- K080836 — MODIFICATION TO ENDOFAST RELIANT SYSTEM
- K063810 — YULEX LATEX POWDER-FREE EXAM GLOVES
- K071447 — VARIOS 75
- K072548 — CREATINE KINASE LIQUID REAGENT, MODEL C519-440
- K072682 — 50W CERALAS D 1950NM DIODE LASER
- K072714 — TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
- K072905 — 3TEST SUPREME GLUCOSE MONITORING SYSTEM
- K073231 — ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
- K073269 — HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM
- K080311 — MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM
- K080757 — AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
- K080805 — MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
- K080945 — FCR GO PORTABLE DIGITAL X-RAY SYSTEM
- K080961 — NM APPLICATION SUITE
- K071261 — ISOBAR SEMI-RIGID DUAL DAMPENER
- K072729 — SIERRA
- K073585 — INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
- K073690 — INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM
- K080070 — K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
- K080525 — COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
- K080608 — DIGITAL LIGHTBOX
- K080704 — LOW FLUID ALARM
- K080774 — CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
- K080787 — BIOMOVE 5000 SYSTEM
- K080863 — TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
- K071591 — RAMP INFLUENZA A/B ASSAY
- K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
- K073449 — SURGICASE
- K080058 — TURBO PRIME IBD SYSTEM
- K080082 — OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS
- K080270 — MANUAL RIGID MOBILITY WHEELCHAIR
- K080526 — SIERRA SYSTEM
- K080553 — DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
- K080567 — PALOMAR ASPIRE LASER PLATFORM
Data sourced from openFDA. This site is unofficial and independent of the FDA.