FDA 510(k) clearances — page 451
clearances on record, most recent first.
Clearances — page 451
45,001–45,100 of 176,542- K111188 — COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
- K113072 — TINA-QUANT ALBUMIN GEN.2
- K113194 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
- K113215 — MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
- K113266 — GEL-BLOCK EMBOLIZATION PLEDGETS
- K120077 — COMED K-SERIES MANUAL WHEELCHAIR
- K120160 — ROCAMED ROCAUS PLATINUM
- K120166 — COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
- K120257 — MLS, ZERONA-AD
- K120497 — EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
- K120571 — SYNTHES USS CONNECTOR
- K120692 — LATEX EXAMINATION GLOVES (POWDER FREE)
- K120736 — SR PHONARES II
- K120798 — DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR
- K121127 — SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
- K112511 — DOBBHOFF DUAL PORT FEEDING TUBE
- K112669 — TATTOOSTAR EFFECT Y
- K113333 — KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
- K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
- K120119 — SUNMED GUIDE WIRE
- K120183 — ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
- K120185 — INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
- K120249 — TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
- K120296 — CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
- K120449 — HEALIX ADVANCE PEEK ANCHOR
- K120821 — LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM
- K112158 — MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
- K112660 — POCKETCPR
- K112794 — EOS SMALL BONE FIXATION SYSTEM
- K112856 — LUCINA-MELODI
- K112896 — ARRW EVOLUTION
- K112952 — ILWAIT TIMER OCULOPRESSOR
- K113177 — COMPLETE D 25-OH VITAMIN D CONTROL
- K113813 — SENTRYSUITE PRODUCT LINE
- K120327 — VERTESSA
- K120369 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
- K120521 — GC BLUE SILICONE
- K120537 — AQUAMANTYS3 9.5 XL BIPOLAR SEALER
- K121132 — EZSENSOR P DIGITAL INTRAORAL SENSOR
- K121279 — ELECSYS LH CALCHECK 5
- K120353 — SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
- K120491 — DSS STABILIZATION SYSTEM-RIGID
- K121084 — LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
- K102841 — PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
- K110420 — OPHIRA MINI SLING SYSTEM
- K112266 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
- K112334 — VEIN-GOGH INSTRUMENT
- K112378 — COBES SURGICAL DRAPE
- K112403 — AMSCO CHIMERON MEDIUM STEAM STERLILZER
- K113451 — NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
- K113521 — CALCIUM GEN. 2
- K113577 — MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR
- K113639 — C2 MEDICAL GLOVES
- K113670 — ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
- K113751 — RANDOX COCAINE METABOLITE
- K113853 — G+ SYSTEM
- K120026 — PERFORMER HT/ HANG&GO HT BASIC
- K120072 — VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
- K120149 — SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA
- K120298 — CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
- K120394 — LIFESTYLES ZERO LUBRICATED LATEX CONDOM
- K120396 — RELIANCE CERVICAL IBF SYSTEM
- K120513 — GLOW BY ENDYMED
- K120637 — SYNAPSE 3D BRAIN PERFUSION
- K120693 — LATEX EXAMINATION GLOVES (POWDERED)
- K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
- K120761 — LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
- K120860 — INFU BOX TYPE 0412A
- K121072 — SOMATOM DEFINITION FLASH
- K121116 — PLATEAU SPACER SYSTEM
- K121166 — WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
- K121209 — TERUMO PALL AL20X ARTERIAL FILTER
- K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
- K113713 — GEN_2 MECHANICAL WHEELCHAIR
- K113732 — IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
- K120106 — APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
- K120550 — CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
- K120724 — PIONEER LATERAL PLATE SYSTEM
- K112279 — QUANTUM DENTAL IMPLANT SYSTEM
- K112549 — IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
- K112665 — TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
- K112671 — STERILCONTAINER SYSTEM
- K112797 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
- K113340 — KIMBERLY-CLARK CHILD'S FACEMASK
- K113689 — DUKAL LUBRICATING JELLY
- K120020 — VIVIX-S
- K120141 — KENSEY NASH BONE VOID FILLER XC
- K120171 — ACCUSONIC ADVANTAGE
- K120362 — METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY
- K120364 — UNIMED DISPOSABLE BLOOD PRESSURE CUFF
- K120507 — UNITED U2 FEMORAL COMPONENT, PS, #7
- K120518 — END TIDAL CO2 NASAL CANNULA
- K120548 — HLIC NEEDLE-LESS VALVE
- K121015 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
- K121057 — COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
- K102577 — FORCE MEDICAL IM NAIL SYSTEM
- K111409 — APTIMA COMBO 2 ASSAY
- K112083 — LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
- K112995 — GEM PREMIER 4000
- K113216 — RAPIDPOINT 500 BLOOD GAS ANALYER
Data sourced from openFDA. This site is unofficial and independent of the FDA.