FDA 510(k) clearances — page 770
clearances on record, most recent first.
Clearances — page 770
76,901–77,000 of 176,637- K020822 — MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
- K020845 — EMIT 2000 VANCOMYCIN CALIBRATORS
- K020865 — ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
- K021065 — PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
- K021090 — OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
- K021102 — DM SLEEVE
- K021148 — MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
- K021171 — Q-STRESS ECHO BED
- K021300 — MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
- K021410 — AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
- K012195 — STEAM STERILIZATION INTERGRATOR
- K012716 — MAINSTREAM WATER PURIFICATION DEVICE
- K020452 — HIGH SILVER CONVENTIONAL
- K020612 — SULTAN SPOROX TEST VIAL, MODEL 75195
- K020720 — OSSIFORM
- K021251 — ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
- K021287 — TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
- K021325 — MODIFICATION OF APEXPRO TELEMETRY SYSTEM
- K021347 — MODIFICATION TO M2376A DEVICELINK SYSTEM
- K011690 — MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
- K020377 — PRE-LOADED BIOSTINGER HORNET
- K020379 — PPD BALLOON DILATATION CATHETER
- K020381 — EXPANDABLE KNEE
- K020383 — ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
- K020384 — T2 ARTHRODESIS NAIL SYSTEM
- K020625 — SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
- K020627 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
- K020679 — INRATIO
- K020716 — RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
- K020781 — WET CHAMBER
- K020917 — SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
- K020937 — MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
- K021037 — MICROSTREP PLUS PANEL WITH AMPICILLIN
- K011426 — PSYCHEMEDICS RIA CANNABINOID ASSAY
- K012113 — INDWELLING FECAL MANAGEMENT SYSTEM
- K012800 — SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
- K014068 — ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
- K014126 — SANIDAD HEALTH-UP TENS MP-73725
- K020354 — BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
- K020365 — 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
- K020374 — OCULIGHT SL/SLX
- K020375 — THE NURTURE III BREAST PUMP
- K020393 — MASTER & FRANK SURGICAL DRAPES (STERILE)
- K020476 — MEDION 6000
- K020510 — SMOKE EVACUATION HOSES/TUBING
- K020554 — MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
- K020760 — STARFLOW HV
- K020797 — PULMO-MIST COMPRESSOR MODEL # 4323
- K020876 — ECHOSCAN, MODEL US-1800
- K021038 — GC ELITE CEMENT 100
- K021091 — EBI XFIX DFS SYSTEM
- K021106 — MODIFICATION TO TSRH SPINAL SYSTEM
- K021108 — ESOP HA FEMORAL STEM
- K021216 — SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS
- K021244 — ACE HA SCREW DENTAL IMPLANT SYSTEM
- K021245 — DEGOTZEN SYNCHRO
- K011727 — TRANSSEPTAL NEEDLE/TROCAR
- K013484 — TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH
- K020341 — GIVEN DIAGNOSTIC SYSTEM
- K020344 — RPX TITANIUM CEMNT RESTRICTOR
- K020348 — ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
- K020349 — ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
- K020408 — SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF
- K020471 — HIVOX EAR THERMOMETER, TS SERIES
- K020567 — AKUPORT M1
- K020623 — DUOPRO SAFETY SYRINGE (DUOPROSS)
- K020687 — DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
- K020751 — SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE
- K020752 — VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
- K020757 — VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
- K020758 — VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
- K020787 — VERDICT-II PROPOXYPHENE
- K020930 — MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
- K021074 — VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
- K021088 — JOGUIDE CARDIOVASCULAR GUIDING C ATHETER
- K021117 — TTI THERMOMED MODEL 1.8 INSTRUMENT
- K021120 — RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP
- K021255 — Y.E.S 10 WHEELCHAIR
- K021282 — LV-1 HEMOSTASIS VALVE, MODEL #6789
- K021283 — GUIDANT BALLOON CATHETER, SEVERAL MODELS
- K021284 — EASYTRAK GUIDING CATHETER
- K021285 — HI-TORQUE EXTRA S'PORT GUIDEWIRE
- K011859 — KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS
- K012614 — KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN
- K013802 — FRC POSTEC
- K013888 — FIXATION (STEINMANN) PINS
- K020053 — SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES
- K020502 — SOLO ORTHO 3
- K020576 — VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
- K020648 — GRIDLOCK 195 ADHESIVE
- K021073 — VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
- K021204 — OLYMPUS BF TYPE UM40
- K021217 — AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP
- K012279 — PATTON TRIPOL
- K020210 — GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
- K020314 — DIGI-PRO TENS, MODEL WL-2204 AND WL-2205
- K020350 — BCI 3180 PULSE OXIMETER
- K020366 — GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
- K020564 — EAV KINDLING 2000S GSR DEVICE
- K020565 — EAV COMBI-2
Data sourced from openFDA. This site is unofficial and independent of the FDA.