FDA 510(k) clearances — page 802
clearances on record, most recent first.
Clearances — page 802
80,101–80,200 of 176,637- K011819 — RADIAL HEAD IMPLANT
- K011858 — INTERLINK THREADED LOCK CANNULA
- K010553 — PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
- K010870 — LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113
- K010974 — RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET
- K011211 — FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW
- K011396 — IBD-CHEK
- K011548 — CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3
- K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
- K003433 — NEURO-TRAIN III (3)
- K003905 — ACTI-ICP MONITORING SYSTEM
- K003920 — CORDIS M3 PTA DILATATION CATHETER
- K010815 — NTERO NOMAD SYSTEM
- K010817 — MX8000 V5.0 CT SYSTEM
- K010837 — HANDMASTER
- K010919 — MALE NATURAL RUBBER LATEX CONDOM
- K011040 — CRYOCARE CARDIAC SURGICAL SYSTEM
- K011183 — OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
- K011262 — MODIFICATION TO THE BOLD SCREW
- K011367 — EXCEL FRACTURE CEMENTED HIP STEM
- K011506 — OMNILINK .035 BILIARY STENT SYSTEM
- K011534 — EEG MIS MONITOR MODEL # A-2000; BIS ENGINE
- K011572 — QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
- K011622 — OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS
- K011623 — EXETER HIP SYSTEM WITH V40 TAPER
- K002543 — COMOACT ULTRASONIC NEBULIZER, MODEL 3060
- K010049 — PULSECO HEMODYNAMIC MONITOR CM71
- K010055 — COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
- K010093 — NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
- K010207 — PORTABLE INSTENSIVE CARE UNIT
- K011035 — DIMENSION DRUG CALIBRATOR, MODEL DC22B
- K011156 — BCI 3403 SLEEP SCREENING PULSE OXIMETER
- K011200 — GILB, MODEL 8010
- K011409 — SLT LASERPRO CTH HOLMIUM LASER SYSTEM
- K011446 — BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
- K011523 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138
- K011526 — HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
- K002695 — MEMODYN STAPLE
- K002727 — YOUNG-HEALTH SUPER EAR THERMOMETER
- K003259 — ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
- K003909 — PROACT 1
- K010831 — AVIATOR PERIPHERAL DILATATION CATHETER
- K010854 — CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
- K010983 — PLLA PIN
- K010986 — LUNAPADS
- K011026 — FORTADERM WOUND DRESSING
- K011095 — MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM
- K011103 — BD SPRING BASED SYRINGE
- K011113 — HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
- K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
- K011134 — OXYGEN SUPPLY TUBING, MODEL 1115
- K011148 — ULTRACONCENTRATOR SYSTEM
- K011231 — CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
- K011234 — BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L
- K011250 — VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
- K011316 — BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T
- K011384 — HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
- K011411 — SELF-ADHESIVE ELECTRODES
- K011450 — SILICONE IMPRESSION MATERIAL
- K011462 — OIL FOR TISSUE CULTURE
- K011463 — VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
- K011464 — RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN
- K011509 — BARRETT UNICONDYLAR TIBIAL BEARING
- K011585 — FAST THERMOMETER MODELS ST713C AND ST713F
- K011598 — WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
- K011693 — TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
- K011795 — WORLAND UNICONDYLAR TIBIAL BEARING
- K001281 — GERATHERM BABYWATCH TEMPERATURE MONITOR
- K001897 — MULTI-STIM, MODEL MS-100
- K003047 — AMBULATORY ENTERAL NUTRITION PUMP
- K003207 — MEDCOMP ULTRA-FLOW CATHETER
- K010181 — CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
- K010209 — ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
- K010766 — SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
- K010770 — BCI ADVISOR VITAL SIGNS MONITOR (9200)
- K010775 — BIOCELLECT
- K010780 — TROCHANTERIC NAIL
- K010945 — HEARTCARD, MODEL 5258
- K010972 — ISOLA BAND CLAMP
- K011007 — TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
- K011193 — NAC PLUS NEEDLELESS ACCESS CONNECTOR
- K011336 — PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
- K011420 — MM-87 MOTOR-DRIVE MANIPULATOR
- K011433 — BALLERT CRANIAL MOLDING HELMET
- K011508 — CD HORIZON SPINAL SYSTEM
- K011529 — T2 HUMERAL NAIL SYSTEM
- K011605 — EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
- K003190 — EN BLOC BIOPSY SYSTEM
- K004017 — H-SCRIBE
- K010301 — IMMUNOWELL EA (D) IGG TEST
- K010634 — HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
- K010751 — BPFONE, MODEL UA 767IT
- K010752 — AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
- K010760 — ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
- K010951 — ISLAND WOUND DRESSING WITH MICROBAN
- K011431 — RESIN CEM
- K002343 — SIGMA DELTA
- K003288 — ORIGEN DUAL LUMEN CATHETER
- K003560 — MAR COR SERVICES BICARB SYSTEM
- K003778 — BREAST-BOARD (MULTIPLE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.