FDA 510(k) clearances — page 498
clearances on record, most recent first.
Clearances — page 498
49,701–49,800 of 175,770- K092937 — STA-HYBRID HEP CALIBRATOR
- K093079 — TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
- K100200 — ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
- K100502 — ASCENSION TOTAL PLATE SYSTEM
- K100556 — SLENDERTONE FLEX MAX, MODEL 517 US
- K100741 — REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012
- K100819 — THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
- K100851 — RANGE SPINAL SYSTEM
- K100946 — INTRAVSCULAR ADMINISTRATION SET
- K101207 — NEODENT IMPLANT SYSTEM
- K101409 — SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
- K101653 — MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES
- K101909 — EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
- K101981 — OPTETRAK LOGIC COMBINATION TIBIAL TRAY
- K091018 — ARTHREX BIOWIRE
- K093000 — EMS PIEZON MASTER 700
- K101010 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008
- K101281 — VEGA KNEE SYSTEM
- K101296 — ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
- K101386 — VIGILANT EEG MONITOR MODEL VIGILANT 2.0
- K101423 — OPTIBOND XTR
- K101507 — AMIGO CLASSIC FD
- K093342 — BIOGENNIX RPC
- K093489 — IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY
- K093608 — GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
- K093724 — FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION
- K100654 — ZOLL PROPAQ MD
- K100889 — ENDOSKELETON TC
- K101261 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K101521 — ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
- K102050 — Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
- K090346 — ADVIA 2120/2120I BODY FLUIDS
- K093664 — AMPHETAMINES II ASSAY
- K093926 — FIREBIRD SPINAL FIXATION SYSTEM
- K100411 — VARIOUS DENTAL IMPLANTS
- K101276 — DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404
- K101295 — MROPEN
- K101322 — JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001
- K101615 — POWERWIRE RADIOFREQUENCY GUIDEWIRE
- K101678 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K101826 — HYDROFIX VASO SHIELD, MODEL HVS-001-0610
- K101879 — XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
- K101949 — PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601
- K102002 — TALYMED
- K093266 — MAM COOLER
- K093493 — AESCULAP STERILCONTAINER S
- K100536 — TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE
- K101026 — POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
- K101076 — PROWESS PANTHER PROARC, MODEL VERSION 5.0
- K101172 — RDT3 HANDPIECE HEAD MODEL RDT3
- K101191 — NAVIAID ICVI DEVICE
- K101663 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K101664 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K092328 — MED-SEG, MODEL BTMS 1000
- K092982 — THE PANPAC SUCTION CURETTE
- K100420 — PHILIPS OBTRACEVUE MODEL SW REV. G.00
- K101662 — SYNAPSE 3D BASIC TOOLS
- K091939 — THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
- K092261 — DEFCON TSA/TSH DENTAL IMPLANT SYSTEM
- K100133 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
- K100147 — S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
- K100247 — DETAX IMPLANTLINK SEMI
- K100543 — MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
- K100682 — GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
- K100813 — QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
- K100909 — REPROCESSED COMPRESSION SLEEVES
- K100958 — MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
- K101101 — MINI-TONG
- K101165 — PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
- K101206 — TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
- K101214 — GUARDIAN CONNECTION
- K101240 — CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467
- K101314 — ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
- K101776 — SCOUTPRO ACS
- K101777 — PIONEER PLUS CATHETER, MODEL PLUS 120
- K101786 — ADVANIX DOUBLE PIGTAIL BILIARY STENT
- K101833 — INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
- K101855 — PROFAST+ ASSAY
- K101866 — CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
- K083418 — CPR MASK
- K092981 — PANPAC VAGINAL PESSARY
- K093981 — YRNSORTIP OXIMANOMETER
- K100488 — IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
- K100544 — IMPIX LUMBAR INTERBODY DEVICE
- K100558 — QUANTA DIODE LASER SYSTEM
- K100640 — 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
- K100706 — VENUS BASIC SPINAL FIXATION SYSTEM
- K101302 — ALEUTIAN IBF SYSTEM
- K101434 — AUDIT MICROCV PROCALCITONIN LINEARITY
- K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
- K101857 — RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
- K101972 — SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS
- K082573 — SARGON NON-EXPANDABLE DENTAL IMPLANT
- K090661 — NES REPROCESSED VARICOSE VEIN RF CATHETER
- K092830 — DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
- K100531 — VISCOPE, MODEL 100P,100S
- K100678 — SUPRA SCAN DELIVERY SYSTEM
- K100766 — IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
- K101043 — ECT DIGITAL THERMOMETER
- K101232 — JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001
Data sourced from openFDA. This site is unofficial and independent of the FDA.