FDA 510(k) clearances — page 452
clearances on record, most recent first.
Clearances — page 452
45,101–45,200 of 175,770- K113642 — PERIMETER INTERBODY FUSION DEVICE
- K113653 — PATIENT MONITOR
- K113716 — ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
- K113752 — METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
- K113762 — CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
- K113862 — ZIO PATCH
- K120029 — HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET
- K103325 — IDS-ISYS INTACT PTH
- K110550 — BRIGHT EMBRACE MODEL SBL60
- K111684 — PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
- K112099 — CONTOUR HEALER
- K112188 — PIEZOTOME SOLO
- K112540 — S-MINI IMPLANT SYSTEM
- K112953 — TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS
- K113322 — CONSERVE THIN SHELL
- K113334 — AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
- K113359 — CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE
- K120047 — CORAL SPINAL SYSTEM
- K120068 — CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)
- K120103 — REST ASSURED GENERATION III DENTAL PROTECTOR
- K120129 — MANTARAY CATHETER
- K110051 — RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
- K112976 — NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
- K113074 — CMAP PRO
- K113165 — MINI-MEDIC
- K113197 — APC FLASH-FREE ADHESIVE
- K120006 — HERO GRAFT
- K120017 — FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
- K103295 — QUICKSCREEN COCAINE 150 SCREENING TEST
- K110691 — ONE PERSONAL LUBRICANT (WATER BASED)
- K110899 — GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
- K111364 — HAPTITE COATING IMPLANT SYSTEM
- K111411 — FREEMIE (R)
- K111515 — SPSMEDICAL SPORVIEW STEAM BI
- K112074 — EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
- K112650 — CONNEXALL SUITE OF SOFTWARE PRODUCTS
- K112736 — PASS LP SPINAL
- K112906 — KLASSIC KNEE SYSTEM
- K113053 — BIPAP A 30 VENTILATORY SUPPORT SYSTEM
- K113149 — SYNTHES USS CONNECTORS
- K113308 — BRUNO ELAN STAIRWAY ELEVATOR
- K113623 — PATIENT MONITOR
- K113744 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)
- K113755 — SAVANNAH TECHNOLOGIES SPINAL SYSTEM
- K111305 — UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
- K112143 — AUDIT MICROCV T-UPTAKE LINEARITY
- K112526 — TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
- K113014 — CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
- K113525 — ACTIVECARE DVT ACTIVECARE+SFT
- K120058 — TRANSTEK BLOOD PRESSURE MONITOR
- K111332 — CLARITY OBP SYSTEM
- K111385 — DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE
- K111413 — BIOGEL (R) INDICATOR (R) UNDERGLOVE
- K112018 — SMART READ EZTEST STEAM
- K112333 — LRT ATTACHMENT
- K112539 — CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE
- K112600 — ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
- K112720 — MCKESSON HORIZON CARDIOLOGY
- K113015 — ALDAHOL V HIGH LEVEL DISINFECTANT
- K113048 — MAXLOCK EXTREME SYSTEM
- K113076 — CAAS A-VALVE
- K113555 — AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- K113764 — GLUCOSE METER-CHECK SOLUTION FOR INFOPIA
- K102383 — MICRODOT & MICRODOT XTRA
- K111294 — SANTORINI SPINAL SYSTEM
- K111595 — NEUMOVENT GRAPHNET
- K112233 — BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
- K112319 — ELECTRO-CAP SYSTEM
- K112804 — FINGERTIP PULSE OXIMETER
- K112875 — BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS
- K112879 — REST ASSURED READY TO WEAR NITE PROTECTOR
- K113049 — SOCKET GRAFT
- K113141 — MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1
- K113185 — MODEL HBP-1300
- K113273 — SPOTLIGHT ACCESS SYSTEM
- K113486 — VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM
- K113522 — PATHASSIST LIGHT SEEKER
- K113524 — VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT
- K113571 — GMK RESUFACING PATELLA SIZE 4
- K113606 — NNC GOLD ABUTMENT FOR BRIDGES
- K113718 — NCB STRAIGHT NARROW SHAFT PLATES
- K113842 — CATHETER CONNECTIONS' DUALCAP SOLO
- K102541 — CYNOSURE CELLULAZE LASER
- K110066 — AQUILION PRIME
- K110312 — CLICKFINE AUTOPROTECT PEN NEEDLE
- K111134 — NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K111232 — GAP ENDO-EXO MEDULLARY SYSTEM
- K111786 — HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
- K111986 — LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
- K112044 — ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
- K112045 — SIMPLELINE II ABUTMENT SYSTEM
- K112427 — BICARB MIXING AND DISTRIBUTION SYSTEM
- K112429 — GIZA(R) VERTEBRAL BODY REPLACEMENT
- K112820 — FORE-SIGHT ABSOLUTE TISSUE OXIMETER
- K112959 — CALG-STR EXERCISE ECG ANALYSIS ALGORITHM
- K113030 — SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
- K113184 — LOGICSCAN 64 LOGICSCAN 128
- K113208 — GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
- K113218 — PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
- K113447 — RISE SPACER
Data sourced from openFDA. This site is unofficial and independent of the FDA.