FDA 510(k) clearances — page 534
clearances on record, most recent first.
Clearances — page 534
53,301–53,400 of 175,825- K090365 — HANSEN MEDICAL ARTISAN S CONTROL CATHETER
- K090428 — ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
- K090505 — SPEQ ULTRASOUND SYSTEM
- K090677 — INNOPORT LAPAROSCOPIC ACCESS DEVICE
- K090691 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K091152 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
- K072288 — PATHFAST D-DIMER
- K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
- K083289 — HUMAN BETA-2 MICROGLOBULIN KIT
- K083822 — LASER TOUCHONE
- K083922 — MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
- K090033 — MODIFICATION TO: PSS SYSTEM
- K090042 — PAINMASTER MCT PATCH
- K090266 — MATCHEDFLICKER
- K090335 — HD GUIDE CATHETER
- K090385 — LARIAT II SUTURE DELIVERY DEVICE
- K090486 — ASTHMA MONITOR MODEL, AM1
- K090490 — MIRAGE ECHO
- K090858 — PARIETEX MONOFILAMENT POLYESTER MESH
- K090994 — LIGAFIX INTERFACE SCREW
- K091267 — VONFLEX PUTTY
- K082612 — GBS PNA FISH
- K083291 — CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
- K083480 — INCLUSIVE ZIRCONIA ABUTMENT BLANKS
- K083502 — PANTHER REALART, MODEL 4.7
- K090288 — ORTHADAPT PR
- K090311 — ELECSYS RUBELLA IGG CALCHECK
- K091139 — CONMED AER DEFENSE SMOKE EVACUATOR
- K091160 — LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
- K091164 — GE VENUE 40, MODEL 5324338
- K091172 — NIO 2MP (MDNG-2121)
- K083733 — LUME 2 SYSTEM, MODEL GA0005000
- K090024 — TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM
- K090157 — ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.
- K090182 — MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)
- K090360 — PHILIPS M3001A MULTI MEASUREMENT SERVER
- K090559 — FOOTPRINT MEDICAL SILICONE FEEDING TUBE
- K090913 — CROSS-PILOT TURBO ELITE SUPPORT CATHETER
- K091016 — COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE
- K080355 — LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
- K081509 — MONTERIS MEDICAL AUTOLITT LASER PROBE
- K081938 — ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
- K082529 — ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
- K082554 — KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
- K082781 — OEC 9900 ELITE
- K083088 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
- K083557 — BCI WW1030 PULSE OXIMETER
- K083628 — GLUCODR AUTO SYSTEM
- K083633 — HS II SHORT FIXTURE SYSTEM
- K083920 — FLOWPICC CATHETER
- K090079 — VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
- K090127 — METATARSAL DECOMPRESSION IMPLANT, MODEL 100
- K090261 — PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
- K090308 — RESTEP DVY SYSTEM, MODEL RSP-101
- K090371 — VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM
- K090684 — AVANTE LEUCITE BLOCKS
- K090849 — MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150
- K090870 — ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY
- K090973 — TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
- K091107 — MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
- K091114 — TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL
- K091146 — MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K082649 — SYNTHES 90 DEGREE SCREWDRIVER
- K090059 — IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM
- K090171 — COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
- K090300 — MODIFICATION TO AUTOFUSER
- K090303 — XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
- K090556 — SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE
- K090892 — GE DATEX-OHMEDA S/5 ADU CARESTATION
- K090963 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
- K082363 — COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS
- K083112 — PRIMADO
- K083586 — I-FIX SYSTEM
- K090228 — ROC LUMBAR PLATING SYSTEM
- K090355 — OPAL SEAL
- K090569 — MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292
- K090594 — DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
- K090638 — GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
- K090701 — EMPRESS DIRECT
- K091017 — CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
- K091084 — MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
- K082038 — CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
- K083203 — HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
- K083508 — SWABCAP
- K083695 — TRAXODENT
- K090038 — SYNGO BREVIS
- K090205 — BCI WW1021 PC APPLICATION
- K090222 — PIONEER LUMBAR PLATE SYSTEM
- K090778 — MTA PROTECTIVE SHEET
- K090809 — MPS ACACIA POWER INJECTABLE INFUSION SET
- K091121 — ORTHOSTAT
- K083793 — STEERABLE GUIDE CATHETER
- K083931 — SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
- K090131 — DS N95 SURGICAL MASKS AND FLAT SURGICAL
- K090176 — NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
- K090236 — DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
- K090822 — ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER
- K090905 — ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
- K082479 — SKLAR SURGICAL GOWN
- K082908 — NOVAGUARD, MODEL 3611001
Data sourced from openFDA. This site is unofficial and independent of the FDA.