FDA 510(k) clearances — page 398
clearances on record, most recent first.
Clearances — page 398
39,701–39,800 of 175,770- K132109 — ENAMELAST
- K132124 — KLARITY VACUUM BAG, KLARITY MOLD CUSHION
- K132450 — CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND
- K132831 — QUIET/SILENT SCANNING SUITE
- K132883 — HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
- K122040 — INVOTEC LARYNGEAL ELECTRODE
- K123155 — LUNA DENTAL IMPLANT SYSTEM
- K130827 — FIRMAP CATHETER
- K131222 — AMPCARE ESP THERAPY SYSTEM
- K131748 — OSSEOFUSE DENTAL IMPLANT SYSTEM
- K131894 — NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
- K131914 — OFFROAD RE-ENTRY CATHETER SYSTEM
- K132014 — GSB GLOBAL SPINAL BALANCE SYSTEM
- K132209 — IPS E.MAX CAD ABUTMENT SOLUTIONS
- K132280 — ALTUS SPINE PEDICLE SCREW SYSTEM
- K132586 — PAXERAPACS
- K132705 — UNIQUE
- K132924 — MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
- K132995 — DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
- K122783 — PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
- K130534 — DIPLOMAT
- K130675 — ARTHREX UNIVERS II CA HEADS
- K130784 — SPIROTEL
- K131116 — U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
- K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
- K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
- K132025 — MESO BILAYER SURGICAL MESH
- K132166 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
- K132248 — FLOWER BONE SCREW SET
- K132305 — STENTBOOST REL. 4
- K132316 — MULTIVIEW
- K132357 — SMITH & NEPHEW ULTRATAPE
- K132796 — SUNTOUCH EYE SPEAR
- K133122 — IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)
- K123910 — WOUNDWASH SALINE SPRAY
- K130048 — REVERSE SHOULDER PROSTHESIS MONOBLOCK
- K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
- K130178 — INSPIRATION VENTILATOR SYSTEM 5I/7I
- K130274 — BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM
- K131190 — MYPATCH
- K131867 — 2.5MM INLINE FUSION PLATE
- K132325 — GUIDOR BIORESORBABLE MATRIX BARRIER
- K123958 — JIAJIAN POINTOSELECT DIGITAL
- K131336 — TX WHEELCHAIR CHASSIS
- K131446 — INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
- K132083 — AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
- K132126 — SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
- K132462 — S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
- K132651 — ITCLAMP 50
- K132866 — NAUTILUS SPINAL SYSTEM
- K132972 — AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
- K123696 — MEDUSA VASCULAR PLUG
- K123713 — IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
- K130428 — COVAMESH
- K130459 — TRIA FAN SYSTEM
- K130529 — RAUMEDIC-PTO-MONITORING-SYSTEM
- K130866 — BIOLIGHT BIODYNAM
- K130904 — TRELLIS-8 PERIPHERAL INFUSION SYSTEM
- K130999 — OSSEOSPEED PROFILE EV
- K131058 — BIPOLAR FORCEPS
- K131162 — MIRADRY SYSTEM
- K132020 — ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
- K132059 — DIAGNOSTIC ULTRASOUND SYSTEM
- K132188 — MAMMOGRAPHY VIEWER SMV658
- K132227 — LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
- K132809 — INSTINCT ENDOSCOPIC HEMOCLIP
- K132900 — MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
- K133124 — IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA
- K122295 — CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS
- K131393 — MAK OSS FEMORAL KNEE COMPONENTS
- K131427 — LOTUS
- K131473 — (QUANTA SYSTEM) SURGICAL LASER FIBERS
- K131881 — OMBRA TABLE TOP COMPRESSOR
- K131887 — TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT
- K131895 — AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
- K132255 — ULTRACEM
- K132338 — DA01 BLOOD GLUCOSE MONITORING SYSTEM
- K132510 — BIOPRO - INFINITY PLATE ANCHOR SYSTEM
- K132512 — HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
- K132556 — SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
- K132804 — ACUSON S1000 / S2000 / S3000
- K133003 — RIGHTEST CONTROL SOLUTION
- K130971 — OPTUM TELEHEALTH APPLICATION
- K131350 — CALIX LUMBAR SPINAL IMPLANT SYSTEM
- K131530 — DYNAMESH -CICAT
- K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
- K131679 — EVOLUTION MP ADAPTIVE PS TIBIAL INSERT
- K132156 — RANDOX CSF CONTROLS LEVELS 2 AND 3
- K132343 — MARIGEN WOUND DRESSING
- K132446 — RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
- K132493 — ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
- K132502 — VARIAX 2 SYSTEM
- K132627 — AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
- K132895 — WMT IMPLANTABLE K-WIRE
- K130897 — MEDCOMP VASCU-PICC WITH VALVE
- K131157 — RANFAC BONE MARROW ASPIRATION NEEDLE
- K131187 — LESSER METATARSAL HEAD IMPLANT SYSTEM
- K131253 — PERIFLUX 6000
- K131963 — TAUTONA INJECTOR DEVICE
- K132435 — SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
Data sourced from openFDA. This site is unofficial and independent of the FDA.