FDA 510(k) clearances — page 772
clearances on record, most recent first.
Clearances — page 772
77,101–77,200 of 175,825- K013927 — MINI SHOPPER
- K013938 — IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
- K013983 — WIENER LAB. ALP 405
- K014012 — DOC BAND
- K014021 — SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED
- K014055 — NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING
- K014103 — SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
- K020140 — VOXAR'S CALCIUM SCORING PRODUCT
- K011074 — CRYOCARE SURGICAL SYSTEM
- K012937 — KNEE MODULE FOR THE STEALTHSTATION SYSTEM
- K013091 — ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
- K013392 — CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880
- K013507 — COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
- K013575 — KPS-I, THE KIDNEY PERFUSION SOLUTION
- K013576 — PERICSCOPE, MODEL # PERISC1
- K013577 — ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
- K013610 — PERIFIX SAFETY EPIDURAL NEEDLES
- K013629 — FINGER JOINT PROSTHESIS
- K013881 — RIBBOND - TRIAXIAL
- K014220 — T2 FEMORAL NAIL SYSTEM
- K014223 — MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
- K014226 — UNITRAX MODULAR UNIPOLAR SYSTEM
- K014229 — MODIFICATION TO OPUS SPINAL SYSTEM
- K014267 — BUTTERFLY PLATE FIXATION SYSTEM
- K014294 — MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414
- K020133 — MODIFICATION TO THE MAESTRO SYSTEM
- K003889 — ANCURE SHEATH MODEL # 40315, 40320, 40325
- K011185 — PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
- K011783 — MULTI-SNARE SET
- K011826 — EPS320 CARDIAC STIMULATOR
- K012534 — HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
- K012749 — BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664
- K013120 — PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
- K013636 — SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
- K013664 — COALESCENT SURGICAL U-CLIP
- K013674 — LUXATEMP/LUXATEMP SOLAR/INSTATEMP
- K013773 — SAFE
- K013899 — VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
- K013964 — MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
- K014008 — HEMOCHRON JR. CITRATE APTT CUVETTE
- K014233 — CAPTIAM SYPHILIS-G ASSAY
- K014238 — DELSONIC 2000
- K010923 — KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
- K011625 — VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)
- K011757 — EXEL COMFORTPOINT INSULIN PEN NEEDLE
- K011967 — BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE
- K012744 — INTRAORAL LENS OPTION TO SPECTROSHADE
- K012766 — PORTABLE INTENSIVE CARE UNIT
- K013303 — CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER
- K013555 — SCI-PHARM POST SECURE
- K013558 — BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
- K014224 — PRECISION PLUS TUNA OFFICE SYSTEM
- K020019 — POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
- K012398 — DIOMED 15 DIODE LASER
- K012480 — VANGUARD REPROCESSED INFLATION DEVICES
- K012602 — CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX
- K013163 — UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
- K013262 — POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
- K013465 — ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
- K013578 — PUMP TUBING
- K013594 — BODY ARRAY COIL
- K013595 — PREMIER III PHASED ARRAY CTL SPINE COIL
- K013620 — MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
- K013738 — WEINMANN SOMNOMASK
- K013769 — V-GNATHOS SUPRA
- K013793 — POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS
- K013794 — POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K013795 — POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR
- K013857 — AIMSTEP PREGNANCY
- K013858 — INFINION 0.6T MR IMAGING SYSTEM
- K013898 — R&D RET-LINE KIT
- K014134 — POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
- K014165 — STIMULUS - DISSECTION INSTRUMENTS
- K020028 — 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX
- K010549 — BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
- K011846 — BIOTECH POWERED WHEELCHAIR, C650PW
- K012293 — VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT
- K012328 — HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER
- K012511 — WATERLASE MILLENNIUM
- K012547 — HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
- K012684 — REPROCESSED ELECTROSURGICAL ELECTRODE
- K012943 — THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
- K013116 — DURQ/ QUALIDURA
- K013128 — N LATEX LP(A)
- K013155 — DADE THROMBOPLASTIN C PLUS
- K013165 — USA SERIES LAPAROSCOPES
- K013228 — 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR
- K013494 — 3.75MM AND 5.0MM SPLINE TWIST IMPLANT
- K013510 — POINT 4 MODIFIED
- K013518 — EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
- K013533 — EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
- K013535 — EVTOOL MODEL # V. 1.0
- K013685 — PLLA CANNULATED INTERFERENCE SCREW
- K013750 — ADVIA 1650 CHOLINESTERASE ASSAY
- K013770 — MODIFICATION TO: WINNER ST-2 STIMULATOR
- K013771 — MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
- K013783 — AUTION MAX AX-4280 URINALYSIS SYSTEM
- K013894 — TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
- K013912 — CREATINE KINASE (CK-NAC)
- K014159 — PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.