FDA 510(k) clearances — page 685
clearances on record, most recent first.
Clearances — page 685
68,401–68,500 of 175,825- K041645 — DDS-ZR
- K041738 — BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)
- K031454 — ACUMEN SURGICAL NAVIGATION SYSTEM
- K031701 — OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
- K040439 — MDI TRIGGER GUARD
- K040841 — POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K040961 — INJECTOR NEEDLE/SNARE
- K040970 — LEONARDO
- K041029 — KINETDX
- K041350 — SYNTHES (USA) CHRONOS
- K041414 — CRONO AND CRONO, MODEL 30
- K041622 — MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
- K041688 — GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04
- K031140 — WATERLASE
- K033488 — CMI MAGNETOCARDIOGRAPH
- K033679 — COPSIOS BONE VOID FILLER (BVF)
- K033926 — HOURGLASS VERTEBRAL BODY SPACER
- K040007 — INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
- K040237 — INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS
- K040988 — ZIRCON-F PROPHYLAXIS PASTE
- K041013 — SUILE OINTMENT WOUND DRESSING
- K041020 — CADSTREAM VERSION 3.1
- K041101 — MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001
- K041140 — ACELL UBM SURGICAL MESH ML AND MLPLUS
- K041243 — DOVER RED RUBBER ROBINSON CATHETER
- K041551 — MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
- K041582 — MODIFICATION TO TRIPTER X-1 COMPACT DUET
- K041584 — KYPHX HV-R BONE CEMENT, MODEL C01A
- K041606 — EXTRACTOR RX RETRIEVAL BALLOON
- K041608 — C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS
- K032905 — 3DKNEE POROUS COATED FEMORAL COMPONENT
- K033953 — OPTIMESH 500E CEMENT RESTRICTOR
- K040459 — TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS
- K040693 — PTS PANELS LDL CHOLESTEROL TEST STRIPS
- K040935 — EBI XFIX DFS SYSTEM
- K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
- K041561 — LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
- K041670 — BIS PEDIATRIC SENSOR
- K033949 — VARILUX VISIONPRINT SYSTEM (VPS)
- K040416 — SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
- K040498 — MYSHELL
- K040930 — ZILVER BILIARY STENT SYSTEM USW
- K041004 — ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
- K041043 — VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
- K041133 — MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
- K041325 — DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE
- K041416 — EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER
- K041424 — NXSTAGE SYSTEM ONE
- K041552 — GE VIVID 7 BT04
- K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEM
- K041576 — SOURCELINK
- K041636 — H&S-CONDUCTIVITY STANDARD SOLUTION
- K022823 — VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
- K032937 — NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
- K033826 — ORTHOPEDIC ALLIANCE SPINE SYSTEM
- K033951 — RADIX CERVICAL PLATE
- K033959 — LPS
- K040096 — SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
- K040155 — PERIPHERAL CUTTING BALLOON
- K040438 — POWERHEART AED G3A
- K040576 — MICROMESAM BASIC-SET
- K040907 — ARTHREX SMALL FRAGMENT PLATES AND SCREWS
- K040932 — EASYNET BODY POSITION MODULE
- K040938 — RADIAL NAIL SYSTEM
- K040946 — ANKYLOS DENTAL IMPLANT SYSTEM
- K040986 — CADWELL LIMB MOVEMENT MODULE
- K041001 — OMEGA 2 SYSTEM
- K041081 — FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
- K041092 — FAST START TENS, MODEL FS 3001
- K041106 — REVISION KNEE SYSTEM
- K041209 — RESMED S8 PIONEER CPAP SYSTEM
- K041302 — REFUGE SOUND GENERATOR
- K041446 — NASALCEASE
- K041449 — SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT
- K041459 — LIFEPAK 12 DEFIBRILLATOR/MONITOR
- K041460 — CD HORIZON SPINAL SYSTEM
- K041466 — TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)
- K041494 — OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2
- K041556 — MODIFICATION TO VERTE-STACK SPINAL SYSTEM
- K041641 — DAVOL DELIVERY SYSTEM
- K041656 — MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
- K041681 — ATRICURE DISSECTOR
- K032438 — MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
- K033174 — BMLS03-3
- K033355 — LACTOSCREW SCREW ANCHOR
- K033402 — PORTABLE SLEEP DATA RECORDER (PSDR)
- K033984 — STRAUMANN DENTAL IMPLANT SYSTEM
- K034043 — H-FLOW VALVE
- K040364 — MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
- K040663 — TELENABLE EMS SYSTEM
- K040674 — IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES
- K040854 — WEST NILE VIRUS IGM CAPTURE ELISA
- K040862 — GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
- K041030 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K041051 — RAICHEM BUN RATE REAGENT (LIQUID)
- K041052 — RAICHEM GLUCOSE UV (LIQUID)
- K041309 — IMASK TM
- K041545 — CONTACT DETACH
- K041550 — HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
- K041569 — CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002
Data sourced from openFDA. This site is unofficial and independent of the FDA.