FDA 510(k) clearances — page 380
clearances on record, most recent first.
Clearances — page 380
37,901–38,000 of 175,770- K140190 — NIGHT SHIFT
- K140326 — XGEO GF50
- K140555 — JOURNEY II BCS CONSTRAINED INSERTS
- K140565 — VARIAX 2 COMPRESSION PLATING SYSTEM
- K140822 — DRIVE RAIL SYSTEM
- K130017 — VALENTINE STEEL WHEELCHAIR
- K131781 — CLEARVIEW TOTAL
- K132416 — REHASTIM 2, ERIGOPRO (FES)
- K132801 — IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
- K133071 — ELASTIC IMPRESSION MATERIAL
- K133316 — SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
- K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
- K133776 — A-DEC/W&H ELECTRIC HANDPIECE MOTOR
- K133953 — LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
- K133956 — NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN
- K140127 — FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
- K140139 — CLEARVIEWHD
- K140332 — XGEO GU60A
- K140334 — XGEO GC80
- K140509 — BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
- K140707 — LIFEBORNE INFANT RESUSCITATOR
- K141091 — RAYSERT PLUS INJECTOR
- K132744 — ACESSA GUIDANCE SYSTEM
- K140038 — DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
- K140423 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K140709 — SKYHAWK INTERBODY FUSION SYSTEM
- K123099 — Best-AV2 Pro-Sport(tm)
- K132684 — MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)
- K132788 — MYSPINE PEDICLE SCREW PLACEMENT GUIDES
- K132838 — NUTRA LIGHT BLUE
- K133057 — VIBRALUNG ACOUSTICAL PERCUSSOR
- K133173 — RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
- K133405 — MINNIE
- K133694 — SHERPA PAK TRANSPORTER
- K140384 — FMWAND HANDPIECE SE
- K140548 — CORCAM HEART MONITOR
- K140630 — WALLFLEX BILIARY RX STENT SYSTEM
- K140729 — APLIO ARTIDA, V3.2
- K141067 — VIVID T8/VIVID T8 PRO
- K141131 — TIGHTRAIL MINI
- K123876 — SYNERGY
- K131588 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR
- K131892 — EV1000 CLINICAL PLATFORM
- K132681 — SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
- K133121 — CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
- K133269 — ZOLL X SERIES
- K133351 — NEXUS NIS-6P LUER ACTIVATED DEVICE
- K133790 — IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
- K140027 — ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER
- K140192 — CARPENTIER BI-CAVAL FEMORAL CANNULA
- K140373 — ISE INDIRECT NA, K, C1 FOR GEN 2
- K140412 — ANS1 SOFTWARE
- K140426 — ANTHRACIS REAL-TIME PCR ASSAY
- K140454 — NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
- K140455 — CAPTIA MEASLES IGM
- K140522 — RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
- K140529 — EVEREST SPINAL SYSTEM
- K140792 — SALVATION 3DI PLATING SYSTEM
- K141220 — APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
- K131609 — DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM
- K132470 — SOLUM IV BONE VOID FILLER
- K132802 — MOTEX POWDERED NITRILE SURGICAL GLOVES
- K132937 — HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
- K133428 — MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
- K133482 — SILC FIXATION SYSTEM
- K133598 — CARDIOHELP SYSTEM
- K133738 — NOVOFINE PLUS 32G 4 MM
- K134043 — NO TOUCH+FOREHEAD NTF 3000 THERMOMETER
- K140074 — HYGEDENT ALGINATE IMPRESSION MATERIAL
- K140094 — SPRINGTMS TOTAL MIGRAINE SYSTEM
- K140151 — EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
- K140169 — VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
- K140340 — SKINTACT
- K140533 — GALAFLEX MESH
- K140611 — TRINICA ANTERIOR LUMBAR PLATE SYSTEM
- K132291 — NAMSA CHEMICAL PROCESS
- K132377 — OSTEOSPAN MORPHEUS
- K133082 — OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
- K140095 — PRIME ZOOM STRETCHER
- K140165 — MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
- K140446 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
- K140447 — BD VIPER LT SYSTEM
- K140448 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
- K140483 — ASAP OTC WOUND DRESSING GEL
- K140576 — Y WIRE 2
- K140835 — GENERAL AND PLASTIC SURGERY
- K140925 — ACUMED SUTURE ANCHOR SYSTEM
- K140948 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K141023 — PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
- K122556 — VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
- K132108 — MAXIO
- K132703 — THUNDERBEAT
- K133014 — DMS 300-2W HOLTER ECG RECORDER
- K133793 — PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
- K133853 — VIEWFLEX XTRA ICE CATHETER
- K140526 — NXSTAGE SYSTEM ONE
- K141015 — INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT
- K141043 — CS2 MULTI-HOLE ACETABULAR SHELL
- K131096 — AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
- K132037 — VITAL SIGNS MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.