FDA 510(k) clearances — page 638
clearances on record, most recent first.
Clearances — page 638
63,701–63,800 of 176,637- K060190 — SUPER SHEATH XL INTRODUCER SHEATH
- K060254 — MODIFICATION TO INFINITY EXPLORER
- K060342 — ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
- K060432 — NOVABONE POROUS-BONE GRAFT SCAFFOLD
- K060655 — SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H
- K060703 — PMP4 BP PRO BLOOD PRESSURE MONITOR
- K060749 — XPERCT
- K052118 — DOSE VERIFICATION SYSTEM
- K053543 — ARTHREX ARTHOERESIS IMPLANT
- K060014 — INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS
- K050311 — ATRIUM MEDICAL CORPORATION C-QUR MESH
- K052424 — MAXILIM
- K052515 — SIROENDO
- K052794 — ETI-MAX 3000
- K052914 — RX IMOLA
- K053569 — AGILITY LP TOTAL ANKLE PROSTHESIS
- K053583 — OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL
- K060082 — TIANJIN MEDIS DISPOSABLE INFUSION SET
- K060236 — MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
- K060255 — E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE
- K060269 — ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM
- K060296 — NXSTAGE DIALYSATE PREPARATION MODULE
- K060542 — GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX
- K060550 — KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386
- K060634 — NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES
- K060672 — ONE STICK Y EXTENSION SET AND VOLUMETER
- K060689 — 1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL
- K060737 — SINMED POSITIONING DEVICES
- K050123 — P-STIM SYSTEM
- K051670 — RF TUNNELER WIRE
- K052693 — PM-50 PULSE OXIMETER
- K053366 — NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
- K060038 — SBI RADIO-CAPITELLAR IMPLANT
- K060075 — FIBER-METAL POST
- K060124 — ATRIUM FLIXENE GRAFT
- K060303 — VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS
- K050945 — ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS
- K051058 — METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
- K051753 — ACCU-SOURCE
- K052122 — BISCO LED
- K052383 — INNOCURE IMRT FILTER (COMPENSATORS)
- K052525 — CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
- K052788 — N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
- K053123 — PD CATH
- K053368 — INTERPROXIMAL REDUCTION SYSTEM
- K053383 — FIDIS CELIAC
- K053521 — PRE-POWDERED STERILE VINYL GLOVE, CLEAR
- K053626 — INTERX500 FLEXIBLE ARRAY ELECTRODE
- K060074 — INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
- K060171 — CLEANSE S+ ULTRASONIC SCALER
- K060197 — ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28
- K060298 — PILL PHONE
- K060310 — FRAXEL II SR LASER SYSTEM AND ACCESSORIES
- K060332 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
- K060344 — O-ARM IMAGING SYSTEM
- K060493 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA.
- K060505 — VOXAR 3D ENTERPRISE, MODEL 6.1
- K060547 — ACCESS BREAST COIL 4/SMS
- K060673 — PEDIATRIC URETERAL STENT
- K051197 — ACULIFE, MODEL SMW-01
- K052297 — POREX ELECTROSURGERY NEEDLE
- K052898 — IQMARK EZ STRESS
- K053072 — N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
- K053073 — N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
- K053079 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
- K053300 — SYVEKEXCEL
- K060403 — PTA (PROGRESSIVE TIBIAL ALIGNMENT)
- K060464 — COULTER 5C CELL CONTROL
- K060469 — OPTIBOND ALL-IN-ONE
- K060520 — VITAMESH MACROPOROUS PP SURGICAL MESH
- K060523 — NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
- K060528 — AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
- K060543 — ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
- DEN050007 — HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
- K060120 — TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
- K060306 — ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY
- K053384 — FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM
- K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
- K060066 — VERIFY 3-10 MIN FLASH INTEGRATOR
- K060175 — ISIGHT IMAGING CATHETER, MODEL 38986
- K060215 — ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002
- K060454 — TITAN GUIDEWIRE
- K060541 — THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS
- K052891 — HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
- K053164 — IPLAN FLOW
- K053229 — MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
- K053360 — AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
- K053494 — OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
- K060007 — BD AUTOSHIELD PEN NEEDLE
- K060043 — KHAN KINETIC TREATMENT DEVICE (KKT-M1)
- K060230 — DOPPLEX CENTRALE
- K060301 — PALOMAR LUX1540 HANDPIECE
- K060312 — MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML)
- K060486 — CYCLONE, MODEL MAICAM 180
- K060487 — LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
- K060515 — DEPUY PFC SIGMA KNEE PROSTHESIS
- K051510 — SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM
- K052999 — SEMPERFLO INFUSION SYSTEM
- K053466 — HSINER RESUSCITATOR
- K060239 — ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.