FDA 510(k) clearances — page 794
clearances on record, most recent first.
Clearances — page 794
79,301–79,400 of 176,637- K011815 — SYNTHES LCP PROXIMAL HUMERUS PLATES
- K011818 — STERILE EMG ELECTRODES
- K011821 — MODIFICATION TO THE I.C.O.S SCREW
- K011823 — BIOREHAB SYSTEM
- K011875 — MODIFICATION TO THE TAC' PIN
- K011908 — OPTIBOND SOLO PLUS 3
- K012050 — VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
- K012055 — 3.25MM SPLINE TWIST IMPLANT
- K012332 — JAS CARBON DIOXIDE LIQUID REAGENT
- K012360 — LC TEMPORARY FILLING
- K012441 — PANAVIA F
- K012539 — VERASTEP
- K012564 — MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
- K012568 — GE VISION NUCLEAR MEDICINE WORKSTATION
- K012584 — MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
- K012656 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
- K002394 — JMS APHERESIS NEEDLE SET ACCORDION TYPE
- K010935 — BRITESMILE BARRIER MATERIAL
- K011763 — OMNIDOS
- K011774 — R120 MODULAR TOTAL HIP SYSTEM
- K011790 — MICROCRUISER PLUS INTRODUCER SET
- K011820 — DENTORIUM CONVERTIBLE ACRYLIC
- K011981 — MHS 5000
- K012180 — A-WEAR
- K012342 — AMS SOFT-TISSUE APPROXIMATION SYSTEM
- K012438 — MODIFICATION TO PANAVIA 21
- K012440 — MODIFICATION TO CLEARFIL LINER BOND 2V
- K012573 — CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC
- K003548 — PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS
- K010424 — NEXAN SYSTEM, MODEL NX-301
- K010621 — ACCU-SPACE ABSORBABLE SEEDING SPACERS
- K011674 — DC - CRISTAL
- K011785 — NOVEL PRINT CYAN ALGINATES
- K011854 — TOKUYAMA M-BOND
- K011868 — ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
- K012177 — VENTVIEW, MODEL 8414095
- K012392 — DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
- K012405 — EXTRUDE MODIFIED
- K012432 — MODIFICATION TO CLEARFIL PHOTO BOND
- K012436 — MODIFICATION TO ALLOY PRIMER
- K012468 — MODIFICATION TO N/T PROTEIN CONTROL SL
- K012541 — MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET
- K012799 — ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL
- K010204 — STRYKER NAVIGATION SYSTEM-KNEE MODULE
- K011427 — MBI PD-103 SL; MBI PD-103 SH
- K011543 — TENS CARE, MODEL XL-Y3
- K011725 — OLYMPUS SUCTION PUMP, MODEL KV-5
- K011781 — INTERCEPT-URETHRAL MICROCOIL
- K011873 — DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
- K011912 — MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
- K012162 — STRYKER PLATING SYSTEM BASIC FRAGMENT SET
- K012292 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
- K012296 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
- K012317 — COALESCENT SURGICAL U-CLIP
- K012476 — MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
- K012530 — AA-1 SYSTEM
- K012663 — EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
- K002908 — JET THERAPY
- K003804 — SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
- K010404 — EXEL I.V. ADMINISTRATION SET
- K010968 — VECTORVISION CT/FLUORO
- K011716 — THE UNI-CLIP STAPLE
- K011722 — ATRICURE BIPOLAR COAGULATION SYSTEM
- K011729 — SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
- K011745 — HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
- K011747 — PALOMAR LC 100 DIODE LASER
- K011769 — OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
- K011775 — MICRO TARGETING DRIVE SYSTEM
- K011983 — INSIGHT GENESIS
- K012169 — ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1
- K012253 — SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM
- K012322 — OPTIBOND 2
- K012341 — TRANSLUX ENERGY
- K012488 — MODIFICATION TO:ENDIUS BIPOLAR SHEATH
- K012489 — MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10
- K012507 — THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)
- K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
- K012855 — LIQUISPX LIQUID LIPID CONTROL
- K003198 — VULCAN TAC PROBES, MODEL 911XXX
- K003555 — SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
- K011694 — VIEWSTATION
- K011703 — LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
- K011949 — ELK LASER IMAGER, MODEL EL-DRY 4000
- K011984 — BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
- K012080 — SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
- K012151 — HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K012493 — ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
- K012513 — LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642
- K012561 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
- K012728 — E-SCAN MRI SYSTEM
- K002172 — POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)
- K010203 — ACCU-PULSE TENS UNIT
- K011827 — ORTELIUS 800
- K011844 — MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
- K011905 — SNIPER ELITE MODEL-OR-E3872XX SERIES
- K011937 — TRULINE INFUSION CATHETERS
- K012044 — BI-PHASIC INFILTRATOR
- K012083 — ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
- K012130 — ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
- K012225 — ATTAIN 6215 VENOGRAM BALLOON CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.