FDA 510(k) clearances — page 419
clearances on record, most recent first.
Clearances — page 419
41,801–41,900 of 175,770- K130092 — SIMMETRY SACROILIAC JOINT FUSION SYSTEM
- K130196 — SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
- K130197 — BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
- K120817 — QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
- K122502 — BRIDGE EXTRACELLULAR COLLEGEN MATRIX
- K123316 — HEINE OMEGA 500
- K123433 — CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
- K123529 — ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
- K123668 — ORTHOCORD
- K124052 — OSTAVI HYDROPHILIC GUIDEWIRE
- K122578 — VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
- K123238 — ACHILLES
- K123548 — THE ARTAS SYSTEM
- K123549 — POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
- K123656 — VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K121043 — OPTOS OCT/SLO MICROPERIMETER
- K121374 — ZI BLOWER
- K121406 — INCLUSIVE TAPERED IMPLANT SYSTEM
- K121435 — SILKN BLUE
- K121738 — MYVISIONTRACK(TM)
- K121795 — CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
- K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
- K122185 — U-MOTION II ACETABULAR SYSTEM
- K122286 — MAMMOMAL INSPIRATION
- K122361 — T:CONNECT DATA MANAGEMENT SYSTEM
- K122640 — VPULSE
- K122720 — LIFESTYLES WARM LOVIN PERSONAL LUBRICANT
- K122727 — BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
- K123187 — RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA
- K123459 — ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
- K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC
- K123646 — EMORY CARDIAC TOOLBOX 4.0
- K123681 — 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
- K123740 — EOS
- K123809 — CD HORIZON SPINAL SYSTEM
- K124061 — MRI PATIENT MONITORING SYSTEM (MODEL 865214)
- K130058 — ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
- K130143 — PERSONA NATURAL TIBIA BASEPLATES
- K113549 — COMFORT COUGH
- K120861 — FIN-S MICROIMPLANT
- K121735 — FIBER DISK AND BLOCK PERMANENT, TRINIA
- K122516 — EMBLETTA MPR
- K122967 — LUCENT
- K123175 — DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343
- K123337 — VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM
- K123638 — PEKKTON IVORY
- K123651 — CINCHLOCK KNOTLESS SUTURE ANCHOR
- K123680 — COPRANCOLOR
- K123824 — VITRO FIL LC
- K123974 — PERCUTANEOUS INTRODUCER KIT
- K123994 — DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
- K124002 — VERIFICATION CONSOLE
- K124060 — MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
- K130038 — POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
- K123424 — MDU5 PLUS STERILE BAG
- K123425 — TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
- K123613 — SYNSPAR ADVANCED
- K123650 — ARIX RAD ACQUISITION CONSOLE
- K110941 — REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
- K120851 — COMMUNIFY PACS VIEWER
- K121928 — DESARA SL
- K122477 — LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
- K123154 — ARTAS SYSTEM FROM RESTORATION ROBOTICS
- K123469 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
- K123575 — MAMMOWORKSTATION
- K123588 — INTRADERMAL ADAPTER
- K123595 — NEXUS RMGI
- K121608 — VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
- K122177 — ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
- K122315 — FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC
- K122518 — SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
- K122710 — TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND
- K122726 — CPI RAD VISION
- K122894 — GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC
- K123164 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
- K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
- K123321 — DIMENSION CHEMISTRY III CALIBRATORY
- K123525 — GRIDLOCK PLATING SYSTEM
- K123835 — 2008 HEMODIALYSIS SORBENT SYSTEM
- K130200 — PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
- K120038 — A200 KNEE SYSTEM
- K120181 — LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
- K120673 — DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
- K120675 — DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES
- K121241 — MALE LATEX CONDOM
- K121433 — GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
- K121919 — SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
- K122054 — LIFESTYLES NATURAL PERSONAL LUBRICANT
- K122184 — ECG CHECK
- K123072 — VASHE WOUND THERAPY SOLUTION
- K123166 — TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P
- K123176 — ISO-GARD CLEARAIR MASK
- K123211 — A5 ANESTHESIA DELIVERY SYSTEM
- K123235 — EQUAFLOW MULTIVALVE INFUSION CATHETER
- K123240 — SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
- K123623 — ILLICO MIS POSTERIOR FIXATION SYSTEM
- K123647 — CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE
- K123826 — VITRO MOLAR
- K123840 — CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
- K123851 — GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
Data sourced from openFDA. This site is unofficial and independent of the FDA.