FDA 510(k) clearances — page 483
clearances on record, most recent first.
Clearances — page 483
48,201–48,300 of 176,542- K102342 — KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
- K103760 — TITAN
- K103835 — REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N
- K110358 — VENODYNE V810
- K110549 — ENSITE VELOCITY SYSTEM
- K110593 — OWL RF PROBES
- K110875 — CENTRICITY PACS
- K110963 — ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
- K110973 — IE-ZEN (IN CLEAR SERIES HEARING AID)
- K111099 — ISSYS LP SPINAL FIXATION SYSTEM
- K111102 — RADIOVISION
- K111185 — RELYX LUTING PLUS AUTOMIX
- K102307 — GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
- K102324 — ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
- K102681 — ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
- K102922 — HARDYCHROM MRSA
- K103112 — AFFYMETRIX GENE PROFILING REAGENTS
- K103764 — REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
- K110438 — SENSILASE PAD-IQ
- K110440 — QUICK UP
- K102843 — MAC MALE ADAPTER
- K110039 — BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
- K110087 — CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
- K110349 — CLEAR+BRILLIANT LASER SYSTEM
- K110384 — DILON 6800 ACELLA (ACELLA)
- K110446 — ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
- K110573 — READY VIEW
- K110620 — PREMIER C. DIFFICILE GDH
- K110932 — TINNITUS SOUND GENERATOR MODULE
- K110976 — ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
- K110985 — ICON ADULT MANUAL
- K111056 — PICCOLO COMPOSITE NAILING SYSTEM
- K101991 — WEBSTER DUO-DECAPOLAR CATHETER
- K102191 — TRANSTEK GLASS BODY ANALYZER (4 models)
- K103793 — DURAFIBER AG
- K093640 — DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA
- K101348 — AGACHAMBER SPACER
- K103196 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K103343 — L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
- K110037 — PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID
- K110253 — REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
- K110266 — MAC 5500 HD, MAC 3500
- K110455 — KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
- K110561 — FORTROSS BONE VOID FILLER
- K110903 — PTS-X SIZING BALLOON CATHETER
- K110909 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..
- K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
- K102152 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K102481 — AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
- K102895 — ONE DAY FLAT PACK
- K102957 — CUTTING EDGE SPINE INTERBODY FUSION DEVICE
- K103455 — SPECTRA LASER SYSTEM
- K103683 — IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
- K103758 — MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
- K110025 — SECTRA MICRODOSE MAMMOGRAPHY
- K110105 — BD PEN NEEDLE
- K110123 — PCL TIGHTROPE
- K110286 — GN OTOMETRICS TYPE 1053 FREEFIT
- K110288 — FEMVUE SALINE-AIR DEVICE
- K110582 — VALO CORDLESS
- K110750 — PERIOPATCH
- K110772 — BIOMARC FIDUCIAL MARKER
- K110911 — RENAISSANCE SYSTEM
- K102151 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K102517 — TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
- K103204 — SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
- K103557 — DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
- K103599 — UNIVERSAL DIGITAL INTERFACE (UDI) 1717
- K103842 — UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
- K110282 — LIGHTY DD INFUSION SET
- K110331 — SENSITITRE AIM (TM)
- K110502 — TRIPLEX ER. YAG / ND: YAG SYSTEM
- K110764 — FILMARRAY RP PANEL
- K110845 — IMPELLA CONTROLLER WITH FLOW CONTROL
- K110865 — AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
- K111021 — CUBESCAN / BIOCON-700
- K102557 — NOVAKONE SPHERICAL AND TORIC LENSES
- K103363 — ZEUS ELISA HSV GC-I IGG TEST SYSTEM
- K110421 — DISPOSABLE INSULIN SYRINGE
- K110834 — AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
- K110849 — PRESTODR 4143
- K110862 — VAPRO PLUS INTERMITTENT CATHETER
- K110999 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K100496 — INVADER MTHFR 1298
- K102194 — SOLCART B
- K110377 — PROTECTIVE RESTRAINT
- K102606 — AVS ANCHOR-C CERVICAL CAGE SYSTEM
- K102902 — RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR
- K103484 — GSP NEONATAL THYROXINE (T4)
- K103817 — POSEY BED
- K110355 — VENX REVOLUTION
- K110395 — C.T.M. MOBILITY SCOOTER - MODEL HS 118
- K110567 — C.T.M. MOBILITY SCOOTER HS515(3W)
- K110671 — WINCO STRETCHAIR
- K110837 — REVISION PROTHESIS
- K100862 — BODYFLOW P2CH
- K103194 — INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM
- K103324 — PRECISION LIQUID OXYGEN SYSTEM
- K103602 — EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
- K103766 — XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.