FDA 510(k) clearances — page 440
clearances on record, most recent first.
Clearances — page 440
43,901–44,000 of 175,770- K112030 — SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
- K112508 — I-ROOT 100
- K112817 — MICROEEG SYSTEM
- K113033 — SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
- K113668 — HEALITE II SYSTEM
- K120286 — TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT
- K121024 — LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8;
- K121250 — OP SPINE SYSTEM
- K112184 — CIRRUS PHOTO
- K112763 — MATRIXBRUSH ENDOMETRIAL SAMPLER
- K120159 — BEAUTICEM SA
- K120503 — CMI IMPLANT IS II ACTIVE
- K120527 — ALPHA ORTHOPAEDICS AT2 SYSTEM
- K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM
- K120910 — CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
- K111863 — SIGNATURE PLANNER,SIGNATURE GUIDES
- K112742 — AUDIT MICROLQ SPINAL FLUID CONTROL
- K112754 — IVENT101
- K113456 — READY VIEW
- K113613 — DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
- K120203 — TM-400 DEVICE
- K120600 — DURAGEN SECURE DURAL REGNERATION MATRIX
- K120823 — BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
- K120870 — GREENLIGHT MOXY FIBER OPTIC
- K120912 — INFINITI(R) VISION SYSTEM
- K121118 — FORA COMFORTSCAN EAR THERMOMETER
- K121130 — POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
- K121246 — MEDYSSY LT CAGE SYSTEM
- K121362 — 1.5T 16CH FLEX SPEEDER LARGE
- K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
- K111048 — SYNTHES SCOUT TACK FIXATION
- K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
- K113008 — KODAMA INTRAVASCULAR ULRASOUND CATHETER
- K113152 — ULTRASONIC SURGERY MACHINE
- K113395 — REVERE 4.5 STABILIZATION SYSTEM
- K113449 — FUSION FLAT PANEL
- K120648 — SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
- K120801 — CHISON DIAGNOSTIC ULTRASOUND SYSTEM
- K121208 — OBIX PERINATAL DATA SYSTEM 7.0
- K121385 — VECTOR
- K121442 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
- K121451 — CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
- K121470 — FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
- K121677 — SUREFIRE HI-FLOW MICROCATHETER
- K111818 — SONIXGPS NEEDLE SENSOR
- K112897 — RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
- K120345 — HONOUR SPACER SYSTEM
- K120506 — PARIETEX COMPOSITE VENTRAL PATCH
- K120546 — AQUILION PREMIUM
- K120573 — MEDART 620
- K120658 — DURABLUE STERILIZATION WRAP
- K121051 — CONCIERGE GUIDING CATHETER
- K121129 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
- K121424 — EXPRESSION INFORMATION PORTAL
- K121437 — MINI MAXLOCK EXTREME PLATING SYSTEM
- K121571 — TUBECLEAR
- K113628 — AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
- K113658 — AMPLATZER VASCULAR PLUG 4
- K120045 — EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
- K120098 — STERILE DISPOSABLES FOR MER
- K120322 — CONMED SUREFIT DUAL DISPERSIVE ELECTRODE
- K120476 — MACROLYTE DISPERSIVE ELECTRODE
- K120665 — INVENT SNORING DEVICE
- K120695 — DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT
- K120769 — MODULTH SLK
- K120772 — NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
- K120833 — DISCOVERY CT750 HD
- K121145 — RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME
- K121249 — MULTIARRAY KIT
- K121328 — AGILITY
- K121487 — LITECURE THERAPY COMPACT
- DEN080015 — NUCLEUS-X PTV CATHETER
- K112729 — BLEASE700/900 SERIES VENTILATORS
- K113022 — PURESLEEP
- K113205 — ARTISYN Y-SHAPED MESH
- K113411 — EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA
- K113868 — EPLUS SKIN TREATMENT SYSTEM
- K120174 — DEPUT DELTA XTEND REVERSE SHOULDER
- K120352 — STRYKER QUIKFLAP STERILE PROCEDURE PACK
- K120494 — DISPOSABLE ADHESIVE SURFACE ELECTRODE
- K121240 — REPROCESSED ENDOSCOPIC TROCARS
- K111604 — LANO-E
- K111718 — LANO-E
- K112860 — PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
- K120164 — PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
- K120214 — TBD
- K120334 — VIVA EB
- K120432 — TELIO CS CEM IMPLANT
- K120465 — EARLYSENSE (EVERON) SYSTEM
- K120470 — MIPAL
- K120551 — SIMUPLAN TREATMENT PLANNING SYSTEM
- K120624 — ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
- K120752 — AERODR STITCHING SYSTEM
- K120784 — TUFF-TEMP 2.0
- K120790 — GMK - LINE EXTENSION
- K120820 — GIRAFFE BLUE SPOT PT LITE
- K120846 — TRANSPORT CULTURE MEDIUM DEVICE
- K121011 — AMISTEM AND QUADRA - LINE EXTENSION
- K121074 — SCENIUM 2.0
- K121402 — CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G
Data sourced from openFDA. This site is unofficial and independent of the FDA.