FDA 510(k) clearances — page 429
clearances on record, most recent first.
Clearances — page 429
42,801–42,900 of 175,770- K120765 — VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
- K121312 — INTRAMEDULLARY NAIL SYSTEM
- K121636 — ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
- K122053 — SHAPEMATCH CUTTING GUIDE
- K122241 — IMAGEN3D
- K122284 — HOFFMANN 3
- K122289 — IMAGE-COM 5.0
- K122292 — RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
- K122422 — PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
- K122924 — CRE FIXED WIRE BALLON DILATION CATHETER
- K122972 — CDC ZIRCONIA BLANKS
- K122989 — BIOMET LATERAL SPACER SYSTEM
- K123012 — SMITH & NEPHEW SMF HIP STEM
- K120545 — HX-461
- K120832 — FORTEX PEDICLE SCREW SYSTEM
- K121551 — RESOLUTE FACET SCREW SYSTEM
- K121657 — PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR
- K121705 — GEO
- K121815 — NUVASIVE SAGE LATERAL PLATE SYSTEM
- K122028 — AURICAL HIT
- K122092 — MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM
- K122280 — IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
- K122523 — CARESTREAM VUE PACS
- K122533 — OSSEOFLEX SB INFLATABLE BONE TAMP
- K123109 — ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
- K120728 — PHASIX PLUG AND PATCH
- K120747 — XN CAL PF
- K122050 — CPRMETER CPR FEEDBACK DEVICE
- K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
- K122382 — DYNASTY BIOFOAM SHELL
- K122482 — TRANSTEK WRIST BLOOD PRESSURE MONITOR
- K122898 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
- K122984 — ATLAS GOLD PTA DILATATION CATHETER
- K123019 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
- K112605 — SYSMEX XN-SERIES
- K113219 — ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
- K113867 — LACRICATH LACRIMAL DUCT CATHETER
- K120340 — VENUS FACET SCREW SYSTEM
- K120742 — XN CHECK
- K120744 — XN CHECK BF
- K120745 — XN CAL
- K121484 — 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER
- K121709 — ZFX DENTAL CAD SYSTEM
- K121845 — SDX SYSTEM
- K121876 — VERTECEM II CEMENT KIT
- K121931 — NONDISPOSABLE STIMULATING INSTRUMENTS
- K121962 — PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
- K121980 — ZIRPRIME
- K122170 — SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
- K122173 — DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
- K122911 — VERSAFITCUP CC TRIO EXTENSION
- K122913 — AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
- K122916 — JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
- DEN090012 — VIRULITE COLD SORE MACHINE
- K113469 — NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
- K113471 — NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
- K120053 — IPS E.MAX PRESS - ABUTMENT SOLUTIONS
- K120420 — STERILE BLUNT FOR SINGLE USE
- K121741 — 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
- K121849 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
- K121861 — SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N
- K121881 — DOMAIN SURGICAL SYSTEM
- K122499 — AIRCAST VENAFLOW ELITE SYSTEM
- K122882 — NMI HPICC III
- K122896 — COUGAR LS 15 LATERAL CAGE SYSTEM
- K113470 — NIPRO SAFE TOUCH HUBER INFUSION SET
- K113706 — ENDOWRIST STAPLER SYSTEM
- K120641 — GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE
- K120947 — THS INSTRUMENT TRAY
- K121344 — NU SLEEP
- K121581 — BOX PEEK VBR SYSTEM,
- K122085 — STINGRAY CERVICAL CAGE
- K122131 — POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
- K122149 — QBTES
- K122838 — LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
- K122844 — INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR
- K122856 — CHARTER GUIDEWIRE
- K112217 — ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER
- K120192 — DISPOSABLE SURGICAL GOWNS
- K121564 — ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
- K121805 — AMS LARGE PORE POLYPROPHLENE MESH
- K121992 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
- K122139 — SMITH & NEPHEW R3 CONSTRAINED LINERS
- K122332 — TOWERLOX PEDICLE SCREW SYSTEM
- K122465 — MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK
- K123066 — ACCUMESH DEPLOYMENT SYSTEM
- K112087 — TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS
- K120889 — AESKUSLIDES ANA HEP-2
- K121272 — PROTECH DENT
- K121483 — REUSABLE CUTANEOUS ELECTRODE
- K121627 — SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
- K121697 — FINGERTIP PULSE OXIMETER
- K121721 — LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
- K122331 — CAVITY VARNISH
- K122348 — QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW
- K122497 — ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM
- K122547 — GRAM POSTITVE CLINDAMYCIN
- K122837 — AUTOJECT 2 FOR GLASSY SYRINGE
- K111981 — TREGOR DUAL MOBILITY ACETABULAR SYSTEM
- K120199 — GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
Data sourced from openFDA. This site is unofficial and independent of the FDA.