FDA 510(k) clearances — page 463
clearances on record, most recent first.
Clearances — page 463
46,201–46,300 of 175,770- K110327 — LDR SPINE ROI-A INTERBODY FUSION SYSTEM
- K110400 — TAPERLOC COMPLETE MICROPLASTY STEM
- K110474 — PHILIPS INTELLIVUE TCG10
- K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
- K110904 — RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
- K111019 — SURGIMAP (TM) SPINE
- K111366 — BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
- K111412 — SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK
- K111676 — APEX
- K111865 — WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
- K112096 — IMAGELINK
- K112293 — HTS EXTREMITY COIL, HTS SURFACE COIL
- K112320 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
- K112442 — RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
- K112530 — 3DI INCLUDING CSCORE
- K112609 — DESARA MESH
- K112738 — ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
- K110606 — MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE
- K110741 — SCEPTER C OCCLUSION BALLOON CATHETER
- K111350 — MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM
- K111351 — TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET
- K111443 — X12 STERILE REFLECTIVE MARKER SPHERE
- K111522 — CHARTIS CATHETER MODEL CHR-CA-12.0
- K111570 — MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
- K111687 — EMG SYSTEM
- K111816 — EQUIMATRIX
- K111832 — PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID
- K111878 — PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
- K111916 — CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
- K111943 — AGILLS PF DELIVERY SYSTEM
- K112131 — NEODYNE DRESSING
- K112136 — TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
- K112226 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K112434 — BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION
- K112525 — D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
- K112584 — 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
- K103217 — LITE-MED LM-9200 ELMA
- K111475 — AURIGA XL
- K111553 — SPINEFRONTIER LUMBAR IBF SYSTEM
- K112477 — PALINDROME H, SI, HSI CHRONIC CATHETER
- K112496 — PIONEER CROSSFUSE II IBF/VBR SYSTEM
- K112556 — ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
- K103396 — COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
- K110290 — EXETER HIP STEM
- K110673 — HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
- K110800 — META-LOCK SUTURE ANCHOR SYSTEM
- K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER
- K111697 — AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
- K111837 — RADIAL ARTERY COMPRESSION TOURNIQUET
- K111951 — ISOAMP HSV ASSAY
- K112129 — VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
- K112371 — LOGIQ P3
- K112555 — CD HORIZON(R) SPINAL SYSTEM
- K112726 — SONIX ULTRASOUND SCANNER
- K110462 — KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE
- K110497 — PASS LP SPINAL SYSTEM
- K111287 — ASTRA TECH IMPLANT SYSTEM
- K111496 — 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
- K111614 — CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
- K111641 — SURGICASE ORTHOGNATHIC SOFTWARE WIZARD
- K111809 — SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
- K111838 — INQU PASTE MIX
- K111839 — SELECTRA ACCESSORY KIT
- K111845 — THE ESPINER SAC OR E SAC
- K111880 — SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
- K111946 — TEPHAFLEX MESH
- K112232 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS
- K112482 — SELECTRA SLITTER TOOL
- K112524 — HAIRMAX LASERCOMB
- K102938 — ACQPOINT THERMAJADE MASSAGE TABLE
- K103150 — KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK
- K110572 — MAMMODIAGNOST DR
- K110878 — RHYTHMVIEW (TM)
- K110913 — ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
- K111361 — PLANMED NUANCE EXCEL
- K111578 — CORELEADER COLLA-ALGI FIBER MODEL CAW
- K111649 — CS 7600
- K111791 — LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
- K111888 — MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
- K112071 — WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
- K112122 — VENUE 40
- K112463 — UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
- K112474 — CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE
- K112517 — ULTRASEAL XT HYDRO
- K110583 — SENSITITRE OPTIREAD
- K111069 — OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
- K111733 — CORELEADER SCAR-DIMMER
- K111797 — 27 G X 1/2 K-PACK SURSHIELD NEEDLE
- K111934 — PD-100 SERIES ULTRASONIC POCKET DOPPLER
- K111989 — CORONIS FUSION 4MP DL
- K112022 — DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K112347 — RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
- K112431 — DIGITAL ELECTROCARDIOGRAPH
- K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
- K112448 — PULSIOFLEX
- K112455 — AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
- K112645 — RADIFORCE LARGE MONITOR SYSTEM
- K101299 — ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K110061 — CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
- K110435 — EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.