FDA 510(k) clearances — page 519
clearances on record, most recent first.
Clearances — page 519
51,801–51,900 of 175,825- K092440 — ASCENSION CANNULATED SCREW SYSTEM
- K092461 — IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
- K092463 — SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
- K092504 — SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM
- K093160 — HEADWAY 21 MICROCATHETER, MODEL: MC212150S
- K093187 — MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
- K093296 — ALEXIS LAPAROSCOPIC SYSTEM
- K091750 — GUIDELINER CATHETER, MODELS 5571, 5572, 5573
- K092072 — POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
- K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
- K092384 — LIQUICORD
- K092406 — ABG II MODULAR HIP STEM
- K092490 — AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
- K092563 — GATOR CLIPSEAL PLUG
- K092657 — EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
- K093130 — ENGAGE TR INTRODUCER
- K093170 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K093270 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K093276 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K091625 — EPICARE-DUO LASER SYSTEM
- K091927 — INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
- K092320 — ELECSYS PRECICONTROL THYROAB
- K092364 — MODEL 220 PATIENT MAGNET
- K092368 — REPROCESSED PULSE OXIMETER SENSORS
- K092377 — PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S
- K092386 — R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
- K092446 — INTRA LUX HEAD 3 LDSY
- K092822 — CAPRI APPLICATOR
- K082534 — ETEST VORICONAZOLE 0.002-32 UG/ML
- K091192 — KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
- K091531 — CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER
- K091607 — ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
- K091643 — POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K091653 — ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00
- K091743 — SEC VBR
- K092167 — KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600
- K092317 — DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM
- K092359 — ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
- K092362 — SLEEPWEAVER NASAL CPAP MASK
- K092378 — SPECTRANETICS VISISHEATH DILATOR SHEATH
- K092790 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K083133 — SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS
- K090539 — BIPAP AUTOSV ADVANCED
- K090887 — ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES
- K091115 — ECO2 LASER SYSTEM
- K091441 — SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
- K091512 — BUILD-IT LIGHT CURE
- K091736 — SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
- K091913 — HI TECH IMPLANT, HT PHYSIO IMPLANT
- K092205 — PALINDROME P HEMODIALYSIS CATHETER
- K092251 — BIODENTINE
- K092309 — SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
- K092318 — BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
- K092342 — SMARTPILL GI MONITORING SYSTEM, VERSION 2.0
- K092403 — TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
- K092536 — SPINAL FIXATION SYSTEM
- K092547 — DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX
- K092581 — MITS DICOM GATEWAY AND IMAGE MANAGER
- K092585 — ELECSYS RUBELLA IGGA CALCHECK 5
- K092623 — F.A.S.T. SYSTEM SED AND CXD
- K092717 — DIRECT DIGITIZER, REGIUS MODEL 210
- K093221 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
- K093234 — INTEGRATED REGISTRATION
- K093300 — ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES
- K083080 — IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM
- K090639 — EXELO2, MODEL 4010
- K090689 — QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
- K091290 — ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
- K091761 — TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
- K091916 — INNOVANCE D-DIMER, MODEL OPBP09
- K092353 — MONOLISA ANTI-HAV IGM EIA
- K092355 — MONOLISA ANTI-HAV EIA
- K092361 — REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER
- K093023 — PTFE PEELABLE INTRODUCER
- K093251 — OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM
- K082584 — GIVEN ELECTROSURGICAL NEEDLE
- K091284 — VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA
- K091433 — R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
- K091566 — ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
- K091726 — NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980
- K091984 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
- K092011 — NORM SPINAL SYSTEM
- K092245 — ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100
- K092292 — CHECKPOINT
- K092926 — ACELL MATRISTEM WOUND SHEET
- K093002 — AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
- K090055 — LOW & HIGH SPEED KIT
- K090139 — ANKLE ARTHRODESIS PLATE SYSTEM
- K091064 — NAVILAS LASER SYSTEM
- K091174 — VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL
- K091196 — GRS GLENOID RESURFACING SYSTEM
- K091446 — MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
- K091915 — FLUID ISOLATION DEVICE
- K092150 — COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
- K092281 — CLEARFIL MAJESTY POSTERIOR PLT
- K092303 — MERIT LAUREATE HYDROPHILIC GUIDE WIRE
- K092381 — IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION
- K092873 — REVERSE SHOULDER PROSTHESIS
- K092986 — ACACIA PISTON SYRINGE
- K083077 — ULC SPINAL PEDICLE SCREW SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.