FDA 510(k) clearances — page 535
clearances on record, most recent first.
Clearances — page 535
53,401–53,500 of 175,825- K083351 — PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P
- K083509 — LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
- K090138 — MOBILECARE MONITOR, MODEL 2100
- K090178 — ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8
- K090185 — CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM
- K090192 — BILI BLUE F20T12/BBY AND F40T12/BBY
- K090299 — BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
- K090666 — PEDIPLATES
- K090816 — STRYKER SPINE AVS PL PEEK SPACERS
- K090839 — MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS
- K080978 — WALGREEN'S PERSONAL LUBRICATING JELLY
- K082934 — EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
- K083467 — REBOUND HRDV
- K083630 — CLUE MEDICAL AND CLUE MEDICAL BASIC
- K083889 — FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
- K090053 — APTUS 2.0 RADIAL HEAD SYSTEM
- K090217 — BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
- K090464 — BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
- K090695 — DINKLER SURGICAL SKULL CLAMP, MODEL 0308
- K083374 — WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
- K083512 — FLUID-FILLED TEETHER
- K083656 — APEX MEDICAL XT AUTO CPAP 9S-005200
- K090058 — YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB
- K090063 — MERETE LOCKING BONE PLATE SYSTEM
- K090070 — INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
- K090074 — HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
- K090116 — FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
- K090147 — BLOOD MONITORING UNIT, MODEL BMU 40
- K090166 — AVS ANTERIOR LARGE PEEK SPACERS
- K090366 — SPEC MODEL M-31
- K090603 — BARCO 5MP MAMMO, MODEL MDMG-5221
- K090607 — BLUE SKY BIO PLAN, VERSION .38
- K090782 — NOVEL ALIF SPINAL SPACER SYSTEM
- K090799 — MODIFICATION TO EXPEDIUM SPINE SYSTEM
- K091011 — PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
- K091087 — MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
- K091137 — ULTIMUM/ENGAGE/ENGAGE TR
- K072500 — ONE STEP HCG URINE/SERUM TEST
- K082223 — NEUTROLUMENPN SYSTEM, MODEL 1000
- K082325 — APEXUM ABLATOR
- K082698 — ALEUTIAN IBF SYSTEM
- K083350 — TENS/NMES/FES STIMULATING ELECTRODE
- K083554 — CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
- K083794 — MECC SET WITH BIOLINE COATING
- K090013 — CHEMPAQ XBC ANALYZER
- K090134 — INTRAVENOUS POWER INJECTOR EXTENSION SET
- K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS
- K090872 — MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
- K090992 — WELL-PASTE
- K083637 — CALIX SPINAL IMPLANT SYSTEM
- K083815 — LANX FUSION SYSTEM
- K090022 — PARADIS VASO SHIELD
- K090049 — ATLAS IMPLANT SYSTEM- MINI PLUS
- K090506 — MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
- K090657 — MODIFICATION TO: S4 SPINAL SYSTEM
- K090732 — NIO COLOR 3MP AND MDNC-3121
- K090814 — MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
- K082085 — CAPILLARYS IMMUNOTYPING, MODEL 2100
- K083096 — LATARJET CORTICAL SCREW SET
- K083590 — ISKRA MEDICAL GREEN IRF PRESTIGE
- K083834 — TERUMO PALL AL6X ARTERIAL FILTER
- K090237 — HG II FIXTURE SYSTEM
- K090679 — VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
- K090714 — VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K081922 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
- K083111 — IMPELLA 5.0 CATHETER FAMILY
- K083223 — RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
- K083659 — SILVER WOUND PAD
- K083799 — TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00
- K090031 — ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010
- K090239 — PROGASTRO CD ASSAY
- K090475 — VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
- K090631 — PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS
- K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER
- K090728 — HYPERGLIDE OCCLUSION BALLOON SYSTEM
- K090854 — ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
- K072732 — ORTHO T. CRUZI ELISA TEST SYSTEM
- K082091 — TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
- K082997 — TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
- K083058 — IBA PROTON THERAPY SYSTEM - PROTEUS 235
- K083381 — EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
- K083623 — CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
- K083714 — ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)
- K083787 — BCI WW1000 PULSE OXIMETER, MODEL WW1000
- K083871 — ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE
- K083901 — NAVI ROOT
- K083910 — VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER
- K090121 — PRE-FILLED CATHETER INFLATION SYRINGE
- K090215 — MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL
- K090218 — MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ
- K090278 — ENSPIRE DEBRIDER SYSTEM
- K090519 — VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
- K090702 — MODIFICATION TO DASH 2500 PATIENT MONITOR
- K090731 — NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD
- K090886 — RTX 3371
- K090912 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
- K090999 — BIOCARDIA MORPH SHEATH GUIDE
- K082388 — MINICAP IMMUNOTYPING, MODEL: 2300
- K083216 — CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
- K083595 — EZLASE
Data sourced from openFDA. This site is unofficial and independent of the FDA.