FDA 510(k) clearances — page 783
clearances on record, most recent first.
Clearances — page 783
78,201–78,300 of 176,637- K012514 — DIGIPAN / DPI
- K012569 — MODIFICATION TO: INJECTABLE MIMIX
- K013056 — GELCLAIR CONCENTRATED ORAL GEL
- K013193 — MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
- K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
- K013436 — NORMATEC PCD
- K013466 — SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
- K013482 — ABUSCREEN ONLINE OPIATES 300 / 2000
- K013527 — MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
- K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K013606 — ACS 180 HOMOCYSTEINE ASSAY
- K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
- K013652 — WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
- K013698 — AST (SGOT)
- K013800 — INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE
- K013817 — GLO-SPEC
- K013850 — STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
- K013900 — VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
- K013925 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
- K013995 — MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL
- K014058 — ENTEGRA PE PERSONAL DIGITAL ASSISTANT
- K014099 — BIOSCANNER PLUS
- K010559 — SAUFLON MULTI LENS CARE SYSTEM
- K010793 — OXYLOG 1000, MODEL 2M86840
- K011139 — LORENZ LACTOSORB PANELS AND FASTENERS
- K011212 — FILTERFLO H
- K011255 — 3D LINE STEROTACTIC HARDWARE ACCESSORIES
- K011897 — NORIAN SRS BONE VOID FILLER
- K012256 — GELBISH VASCULAR DILATOR
- K012323 — BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
- K012327 — CSIST DICOM GATEWAY/IMAGE MANAGER
- K012660 — GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
- K013132 — SIGN IM NAIL
- K013172 — PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
- K013218 — FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
- K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
- K013273 — FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
- K013308 — VENTLAB HYPERINFLATION BAG SYSTEM
- K013340 — RT-PLUS KNEE ADDITIONAL COMPONENTS
- K013377 — BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
- K013419 — NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM
- K013424 — INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
- K013438 — FRIALIT-2 ESTHETICBASE ABUTMENT
- K013446 — GLUSITE, MODEL GLU002
- K013475 — TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
- K013512 — AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
- K013901 — MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
- K013916 — MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
- K014116 — HAND-CARRIED ULTRASOUND SYSTEM
- K012108 — MEDPOR COATED TEAR DRAIN
- K012199 — DIGICAP
- K013110 — ANISEIKONIA INSPECTOR
- K013141 — MICROGYN PLUS STIMULATION DEVICE
- K013177 — MULTITAK SUTURE SNAP SYSTEM
- K013248 — SYNTHES LCP DISTAL TIBIA PLATES
- K013320 — BLUE LATEX EXAMINATION GLOVES, POWDER FREE
- K013346 — GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
- K013449 — MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
- K013505 — AUROFLUID PLUS
- K013553 — PRE-LOADED ULTRAFIX RC
- K013616 — POLARUS CAP SCREW
- K013798 — PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
- K013823 — XIA SPINAL SYSTEM
- K013829 — MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
- K013860 — AUTO SUTURE SURGICAL STAPLES
- K013877 — CODMAN SLIM-LOC SYSTEM
- K013989 — ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
- K993836 — GENERATION 4 BONE CEMENT
- K002958 — SHAPEABLE DOPPLER FLOW PROBE
- K004047 — HOME-AWAY SYSTEM
- K010925 — SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
- K011907 — SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
- K012040 — RAMP MYOGLOBIN ASSAY
- K012088 — NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
- K012390 — NO STEP ON SITE DEUG TEST CUP
- K012415 — AURIS AEP
- K013019 — DATACAPTOR
- K013139 — STELLARTECH COAGULATION SYSTEM
- K013178 — DC-UIBC-CO2-CAL, MODEL SE-153
- K013251 — SPIRIT 300
- K013380 — ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
- K013406 — ADVIA CENTAUR HOMOCYSTEINE ASSAY
- K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
- K013907 — INVERNESS MEDICAL EARLY PREGNANCY TEST
- K013943 — RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
- K014024 — MODIFICATION TO ALPHA DX SYSTEM
- K014034 — MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
- K981052 — CRESCO TI IMPLANT CONCEPT
- K010850 — POLESTAR N-10
- K011323 — HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
- K013302 — DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
- K013317 — TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K013352 — SUMMIT CEMENTED HIP PROSTHESIS
- K013430 — ACE BIO WIN TIBIAL NAILING SYSTEM
- K013534 — SELF-COUNTERSINKING BONE SCREW
- K013570 — OSSEOTITE DENTAL IMPLANTS
- K013786 — DRG ORTHOHEX SS BONE SCREW
- K013903 — HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
- K013972 — H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
- K011197 — DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.