FDA 510(k) clearances — page 460
clearances on record, most recent first.
Clearances — page 460
45,901–46,000 of 175,770- K111858 — LIFTKAR PT
- K111885 — SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
- K111923 — SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
- K112142 — DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
- K112278 — ASCENSION NUGRIP CMC IMPLANT
- K112282 — M VISUM ALERT ALARM MANAGEMENT SYSTEM
- K112285 — MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE...
- K112397 — ORTHO-JET CRYSTAL
- K112408 — POLY-CHEM 90 ISE MODULE
- K112509 — TRIMED CLAVICLE FIXATION SYSTEM
- K112603 — ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
- K102524 — FUTURA
- K103547 — LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
- K103691 — BIOHORIZONS ABUTMENTS FOR ZIMMER
- K103820 — REPROBONE DENTAL GRAFTING MATERIAL
- K110738 — THERMO SCIENTIFIC MAS OMNI-CORE
- K110989 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
- K111643 — OPTO MITRA YELLOW LASER
- K111648 — BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
- K111902 — AEQUALIS SHOULDER SYSTEM
- K112299 — ENDOVASCULAR LASER VEIN SYSTEM KIT
- K112381 — HI TORQUE CONNECT GUIDEWIRE
- K112945 — ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
- K102378 — VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI
- K102827 — MEDICAL MAGGOTS, LESOC
- K110426 — DYNA-EXTOR II
- K110554 — BIOCERAMIC ORBITAL IMPLANT, ORBTEX
- K111345 — SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
- K111474 — BINGO PRO
- K112185 — FOURSNARE VASCULAR RETRIEVAL SNARE
- K112262 — REFLEX BALLON GUIDE CATHETER
- K112931 — LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
- K112962 — SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
- K112965 — NANO SUTURE ANCHOR
- K113036 — U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
- K100784 — UC-CARE NAVIGO SYTEM
- K102047 — LCI OPTION FOR INNOCOR
- K103338 — COOLTOUCH
- K110221 — EYE-CEPT STERILE SALINE SOLUTION
- K111028 — EUS BALLOON
- K112932 — TRANSTEK
- K112951 — BODY ANALYSIS SCALE
- K111683 — FLIGHT 60 VENTILATOR
- K112345 — DISTAL VOLAR RADIUS PLATING SYSTEMS
- K112961 — CLO-SURPLUS P.A.D.
- K103155 — SUMO ACCESS AND TISSUE RESECTION SYSTEM
- K103251 — DUOCENTRIC REVERSED
- K103278 — ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
- K110057 — MINI MASSEUSE
- K110594 — GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS
- K111693 — PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
- K111988 — EASYSCAN MODEL 1.2
- K112107 — BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
- K112250 — CHX=CHX PLUS
- K112259 — NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS
- K112277 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
- K112445 — SOFRELINER TOUGH S
- K113091 — SYRINGES AND NEEDLES
- K110206 — AESCULAP- MEITHKE SHUNT SYSTEM
- K110326 — OSRAM ITOS
- K110655 — MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM
- K111010 — SPIDERFX EMBOLIC PROTECTION DEVICE
- K111296 — ZOLL RESCUENETLINK
- K111434 — GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
- K111723 — TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- K111796 — INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
- K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2
- K112222 — ALCATRON AND / OR MULTIPLE BRAND
- K112466 — 4MP COLOR LCD MONITOR, RADIFORCERX430
- K112529 — TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
- K112604 — 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)
- K112631 — VSI GUIDEWIRE
- K112670 — DX-D 600
- K112713 — NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
- K112844 — REHASTIM 2, REHAMOVE 2
- K112849 — FIXATE TISSUE BAND
- K112911 — FETAL DOPPLER
- K112917 — ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
- K110551 — EXPEDIUM SPINE SYSTEM
- K111512 — BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
- K111520 — IPC POWEREASE SYSTEM
- K111621 — MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
- K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
- K111828 — CLEARSPLINT ES
- K112000 — VITEK 2 STREPTOCOCCUS PENICILLIN
- K112174 — NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
- K112520 — US-101L, US-103S
- K112689 — SYNTHES STERNAL FIXATION SYSTEM
- K112810 — MULTI-ANALYTE DETECTION SYSTEMS
- K102454 — I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM
- K110998 — AFFIRM (TM) VCF SYSTEM
- K111538 — SKAFFOLD CIS
- K111825 — ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
- K111965 — VUSION(R) OS
- K112192 — NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
- K112249 — HEALIX KNOTLESS(TM) ANCHOR
- K112701 — CHARGER BALLOON DILATATION CATHETER
- K112786 — PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
- K112828 — REVIVE INTERMEDIATE CATHETER (REVIVE IC)
- K112842 — AMS ELEVATE PC
Data sourced from openFDA. This site is unofficial and independent of the FDA.