FDA 510(k) clearances — page 461
clearances on record, most recent first.
Clearances — page 461
46,001–46,100 of 175,770- K102329 — NANOKNIFE SYSTEM
- K102387 — MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES
- K103513 — LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA
- K110569 — AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
- K110783 — VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
- K111948 — WINGEATER V2
- K111993 — FRAMEWALKER
- K112177 — SOFIA ANALYZER AND INFLUENZA A+B FIA
- K112497 — MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
- K112803 — PATIENT MONITOR
- K103684 — VRESELECT CULTURE MEDIUM
- K103791 — PHYSIOGLOVE ES WITH ECG ANALYSIS
- K110992 — ENSPIRE DEBRIDER SYSTEM
- K111030 — E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
- K111639 — FRESENIUS 2008T HEMODIALYSIS MACHINE
- K111854 — AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
- K112166 — ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
- K112292 — REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
- K112415 — LIFECARE ARM & LEG PAIN RELIEF SYSTEM
- K112473 — CD HORIZON SPINAL SYSTEM
- K112746 — DIOSLIMON IMPLANT SYSTEM
- K101286 — SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
- K102278 — QUADRA BLOC TENS PLUS
- K102416 — BD GENEOHM VANR ASSAY
- K103320 — SYNTHES XRL
- K103348 — DIGIVIEW 250
- K110315 — NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
- K110432 — VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
- K110912 — SMART TOUCH UVTHERAPY MULTIPLE MACHINE
- K110919 — CARESTREAM PACS
- K110979 — DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS
- K111155 — XTRAFIX EXTERNAL FIXATION SYSTEM
- K111402 — KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
- K111414 — QUANTA FLASH (TM) DGP SCREEN
- K111542 — DELTEX MEDICAL CARDIOQ EDM
- K111587 — ALERKAN SPIROMETRY FILTER
- K111772 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
- K112211 — DURA BLUE STERILIZATION WRAP
- K112267 — NEUROLAC(R) NERVE GUIDE
- K112269 — OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE
- K112283 — DURA BLUE STERILIZATION WRAP
- K112374 — X-TRA BASE
- K112468 — THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
- K112512 — VANISHPOINT BLOOD COLLECTION SET
- K112626 — LIPSONIX(R) SYSTEM MODEL 2
- K112661 — VIZION DR
- K112737 — TIGER HEADLESS CANNULATED SCREWS
- K112744 — SAPIENS TIP CONFIRMATION SYSTEM
- K112788 — EASTLYTE NA/K/CA/PH
- K112974 — PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
- K110345 — SCANVIEW SYSTEM
- K110804 — AMT G-J TUBE
- K111766 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
- K112098 — TBD
- K110021 — DASH HIP
- K110716 — EVERYWAY LOW BACK PAIN RELIEF SYSTEM
- K111883 — SMARTLOC SPINAL FIXATION SYSTEM
- K111904 — ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
- K111909 — VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
- K111979 — RADIOACTIVE SEED LOCALIZATION NEEDLE
- K112323 — CARDIA-CATH
- K112384 — ABDOMINAL TOURNIQUET SYSTEM
- K112528 — ELECSYS T4 CALCHECK 5
- K112586 — CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
- K112745 — V-14 CONTROL WIRE GUIDEWIRE
- K112759 — APCLO PEDICLE SCREW SYSTEMS
- K112893 — CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
- K112929 — THERMOFLASH(TM) INFRARED THERMOMETER
- K103598 — PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
- K110951 — 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
- K111311 — SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
- K111354 — GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
- K111408 — MICROGARD II
- K111990 — CORONIS 5MP
- K112014 — ZYSTON STRAIGHT SPACER SYSTEM
- K112032 — 8FR TURBO - TANDEM SYSTEM
- K112156 — CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
- K112358 — UNIMAX TROCAR SYSTEM
- K112439 — SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
- K112710 — ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR
- K112874 — EZ VEIN INFLATABLE TOURNIQUET
- K102346 — RANDOX DIGOXIN ASSAY
- K103627 — ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
- K103752 — VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
- K110135 — POLARCUP DUAL MOBILITY SYSTEM
- K110250 — MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
- K110586 — ADVIA CENTAUR VITAMIN D TOTAL ASSAY
- K111120 — CSM SUBMERGED-R IMPLANT SYSTEM
- K111436 — PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX
- K111610 — TRILOGY SERIES VENTILATOR WITH OXIMETRY
- K111737 — DISPOSABLE ELECTRODE
- K111910 — GLADIATOR HIP STEM
- K111958 — TETRIC EVOCERAM BULK FILL
- K111975 — CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
- K111980 — CLEARFIL TRI-S BOND PLUS
- K112086 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
- K112370 — WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
- K112694 — EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
- K112771 — BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
- K112773 — NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
Data sourced from openFDA. This site is unofficial and independent of the FDA.