FDA 510(k) clearances — page 673
clearances on record, most recent first.
Clearances — page 673
67,201–67,300 of 175,825- K043002 — SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
- K043042 — PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
- K043111 — PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A
- K033095 — SMOKE EVACUATION ATTACHEMENT
- K041323 — PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
- K041632 — MINIMESH POLYPROPYLENE MESH
- K041983 — OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
- K042035 — ALUMINA HEAD
- K042039 — FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
- K042256 — IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE
- K042359 — SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
- K042459 — SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
- K042468 — IVENT 201 PORTABLE VENTILATOR
- K042559 — GEM-TWIN TENS/ MODELS GM3XY/Z
- K042580 — TIDI BRAND STERILIZATION WRAP
- K042761 — WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
- K042830 — POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
- K042980 — HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE
- K042986 — MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
- K043008 — SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
- K043012 — OMNIPULSE MINI, MODEL 2120
- K043078 — NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A
- K040912 — HYDROGEL CANALICULAR PLUG
- K041443 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
- K041937 — RESTITU
- K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME
- K042551 — MULTI-CHEM CALIBRATOR A
- K042766 — ORTHOFIX VOLAR DISTAL RADIAL PLATE
- K042824 — FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
- K042877 — MICROVERTER URETERAL ACCESS SHEATH
- K042889 — DYNAMOMETER - MODEL FCE AND MODEL MSC
- K042895 — SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES
- K043016 — SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM
- K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS
- K041007 — MILLENIUM, MODELS 2000, 2001 AND 2002
- K041852 — MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002
- K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
- K042197 — BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION
- K042422 — D3 CHROMA
- K042637 — THE 5.0 X 6.0MM DENTAL IMPLANT
- K042682 — AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
- K042733 — STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
- K042690 — ASCENSION PYROSPHERE (PCS)
- K041595 — TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
- K041967 — GENICON SUCTION IRRIGATION SYSTEM
- K042144 — NICOM
- K042216 — COOL-TIP RF ABLATION SYSTEM
- K042231 — GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
- K042250 — SENSATOUCH
- K042291 — UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
- K042611 — LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
- K042718 — 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
- K042748 — GENEMAX POWER WHEELCHAIR, PW3
- K042749 — GENEMAX POWER WHEELCHAIR, PW4
- K042843 — AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
- K042845 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS
- K042855 — INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
- K042908 — RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
- K042909 — STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A
- K042914 — OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
- K041680 — ORAJEL ADVANCED TOOTH DESENSITIZER
- K041818 — SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
- K041855 — PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S
- K041903 — FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
- K042171 — AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232
- K042188 — VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM
- K042475 — VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC
- K042752 — ACCUPACH V
- K042816 — TRAUMACAD 1.2
- K042853 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA
- K042888 — DEMETRON IDS CURING LIGHT
- K043018 — OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906
- K041069 — SPIRALOK ANCHOR
- K041075 — FASTIN RC ANCHOR
- K041170 — SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
- K042029 — X-SERIES INTEGRAL RPP FEMORAL COMPONENTS
- K042555 — SURGICHIP TAG SURGICAL MARKER
- K042819 — TETRIC EVOCERAM
- K042842 — NOVATION 12/14 PRESS-FIT FEMORAL STEM
- K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
- K042882 — ENTERYX INJECTION CATHETER
- K042935 — GEMINI GXL
- K042949 — PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)
- K041239 — GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
- K041392 — SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US
- K041959 — POLARIS DS/COMET
- K042153 — SOUTH BEACH SMILE LIGHT WHITENING SYSTEM
- K042211 — MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
- K042228 — BEELINE MOTIV, PROPOLIS, PCA
- K042438 — SUPERDIMENSION/BRONCHUS
- K042516 — OTOMIMIX
- K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
- K042537 — SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX
- K042538 — SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX
- K042549 — MULTI CHEM CAL B
- K042550 — MULTI-LIPID CALIBRATOR
- K042557 — INNOJECT AUTO-INJECTOR
- K042566 — VASC-ALERT
- K042700 — IMAGE MEDICAL ACQUISITION STATION (IMAS)
- K042753 — MAMMOTOME MR BIOPSY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.