FDA 510(k) clearances — page 424
clearances on record, most recent first.
Clearances — page 424
42,301–42,400 of 175,770- K123771 — KYPHON EXPRESS II INFLATABLE BONE TAMPS
- K123773 — X-TRA BASE
- K123836 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
- K111105 — CURASAN OSSEOLIVE DENTAL
- K111189 — SYNTEC DENTAL IMPLANT
- K112910 — AP 72OS SEMI-AUTOMATED INSTRUMENT
- K120357 — ENDOSCOPE REPROCESSOR OER-MINI
- K121027 — DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
- K121046 — STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
- K121268 — WANDY DISPERSVIE ELECTRODE
- K121405 — PANOPTIC
- K121582 — INVENDO C25 COLONOSCOPY SYSTEM
- K121913 — REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER
- K121998 — HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED
- K122075 — DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
- K122208 — EXTERNAL FIXATOR SYSTEM
- K122435 — NOVA ONE BLOOD GLUCOSE MONITOR
- K122575 — BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
- K122658 — FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
- K122927 — OXICARE FINGERTIP PULSE OXIMETER
- K122975 — GKS PRIME FLEX CR TOTAL KNEE SYSTEM
- K122991 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K123046 — ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
- K123085 — FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE
- K123093 — STABILINK MIS SPINAL FIXATION SYSTEM
- K123168 — Q-PLUS T+ IPL LASER SYSTEM
- K123255 — g.HIamp
- K123291 — TRUEBEAM
- K123466 — HEALTHVIEW ECG MANAGER
- K123499 — AEROPILOT
- K123528 — SCENIUM
- K123530 — MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
- K123585 — SYNGO, CT CARDIAC FUNCTION
- K123659 — TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
- DEN090007 — BIO-SEAL LUNG BIOPSY TRACT SYSTEM
- K112644 — SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
- K113506 — IND ONE STEP OCCULT BLOOD (FOB) TEST
- K120628 — HELIO
- K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
- K121369 — NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
- K121803 — INTRAVASCULAR ADMINISTRATION SET
- K122217 — CERTUS 140 2.45GHZ ABLATION SYSTEM
- K122321 — BASIXCONPAK ANALOG INFLATION SYRINGE
- K122376 — PMT TRUSCAN SURFACE ELECTRODE
- K122603 — ONTEX AND OTHER PROPRIETARY NAMES
- K122832 — MOBICATH TRANSSEPTAL NEEDLE
- K122954 — CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
- K123184 — FINN CHAMBERS AQUA
- K123359 — OVS1 VIDEO SYSTEM
- K113743 — EVOLUTION 3E VENTILATOR
- K121105 — NUTRISAFE 2 FEEDING TUBE
- K121278 — HERMES MEDICAL IMAGING SUITE V5.2
- K122734 — AESCULAP NOVOSYN ABSORBABLE SUTURE
- K122794 — UPSYLON Y MESH
- K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
- K122875 — ORICARE L2700
- K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
- K123318 — IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
- K123398 — DR. SCHOLL'S COMPRESSION SOCKS
- K123561 — ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
- K123564 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
- K123568 — VERTEX RECONSTRUCTION SYSTEM
- K123695 — TRAUS SIP10
- K110215 — CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
- K120886 — LACRIFAST
- K120946 — ALPHA CRYPTOCOCCAL ANTIGEN EIA
- K120955 — COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM
- K122211 — SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
- K122509 — VERTIFLEX SPINOUS PROCESS FIXATION PLATE
- K100404 — ASCENDX VCF REDUCTION SYSTEM
- K113018 — APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM
- K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS)
- K113377 — GLIADIN IGA AND GLIADIN LGA
- K113779 — CONELOG IMPLANT SYSTEM
- K121117 — NDX ABUTMENTS
- K121498 — PERCUNAV
- K121514 — ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
- K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEM
- K121955 — COUGHASSIST T70 DEVICE
- K122152 — OXTI INFLATION DEVICE
- K122753 — EMPOWER CLEAR
- K122827 — AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
- K122831 — VIDEO SYSTEM CENTER
- K122840 — CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
- K122937 — SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
- K123010 — ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
- K123065 — CATHETER CONNECTIONS DUALCAP SOLO
- K123203 — MAXLOCK EXTREME SYSTEM MODEL MXL
- K123257 — EMVERA DIOLUX
- K123319 — GYRUS ACMI BICOAG HEMOSTASIS PROBE
- K123385 — MEDILAS H LASER FIBERS
- K123531 — UNBALLOON NON-OCCLUSIVE MODELING CATHETER
- K123532 — OCELOT PIXL CATHETER
- K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE
- K120844 — MEDLINX SURGICAL MESH
- K120936 — ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
- K121218 — HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
- K121398 — CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
- K121853 — DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K122269 — ENAMIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.