FDA 510(k) clearances — page 781
clearances on record, most recent first.
Clearances — page 781
78,001–78,100 of 175,825- K002632 — OXYGENATOR
- K011046 — AUTOPULSE, MODEL 100
- K011318 — VENODYNE DVT ADVANTAGE PLUS
- K011952 — DRUGS OF ABUSE MULTI-TEST STRIP
- K012141 — AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
- K012519 — ARTHROCARE ELECTROSURGERY WANDS
- K012717 — LIFE 2
- K012736 — MONOJECT SAFETY NEEDLE
- K012769 — MACROPORE ENT RECONSTRUCTION FILM
- K012848 — WINNER CM4 COMBINATION UNIT
- K012995 — COLLATEK SHEET
- K012997 — COLLATEK FOAM
- K013230 — CERCON BASE
- K013272 — ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
- K000741 — EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188
- K001974 — EZ-ON CONDOM
- K010930 — LIFT VB SPINAL SYSTEM
- K011056 — ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
- K012121 — SECUREGUARD RETRACTABLE SAFETY SYRINGE
- K012143 — 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
- K012419 — CONFORM SHEETING, MODEL IGEL
- K012475 — CAAS II QVA
- K012491 — MACHNET CAROTIDS COIL ARRAY ASSEMBLY
- K012673 — PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
- K012791 — C.T.M. MOBILITY SCOOTER MODEL # HS-320
- K012792 — C.T.M. MOBITIY SCOOTER MODEL #HS-360
- K012822 — MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
- K012832 — COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200
- K012864 — INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
- K012909 — XTERRA GT POWER WHEELCHAIR
- K012990 — COLLATEK POWDER
- K013147 — GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
- K013191 — PASS SPINAL SYSTEM
- K013290 — MODIFIED 650 MAMMOGRAPHY SYSTEM
- K010053 — HUMI-FLOW, MODEL 6-850-00/ 01/02
- K011058 — TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII
- K012838 — ERO50, ORDER-NO.: 2070
- K012840 — EURO 45, ORDER-NO.: 2064
- K013033 — MODIFICATION TO: HL168W TOUCH SCREEN
- K013202 — MODIFICATION TO BRAIDED GUIDING INTRODUCER
- K013325 — POINT 4 FLOWABLE 2
- K011392 — MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
- K011502 — CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM
- K011813 — AMEDITECH IMMUTEST DRUG SCREEN THC
- K011814 — AMEDITECH IMMUTEST DRUG SCREEN COC
- K012453 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
- K012457 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
- K012503 — METAL SCREW ANCHOR
- K012528 — ICE
- K012529 — ROK
- K012625 — REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
- K012719 — NAVIGUS II MR
- K012777 — ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
- K012821 — D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
- K012955 — COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER
- K013059 — STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
- K013173 — BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
- K013237 — STATUSBLUE
- K013277 — ASTRALIS 7, MODEL 557545
- K012309 — RIWO SYSTEM TRAYS
- K012320 — POWERPRO BATTERY SYSTEM
- K012364 — AML HIP PROSTHESIS
- K012510 — MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
- K013016 — TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
- K013135 — IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
- K013144 — DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W
- K013153 — AUTOTOME RX MODEL # 4515, 4516
- K013154 — MARK II/MARK III MANOMETRIC PERFUSION PUMP
- K013156 — MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
- K013162 — 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH
- K013275 — ASTRALIS 10, MODELS # 559588, 561859
- K013356 — WILSON-COOK ULTRASOUND BIOPSY NEEDLE
- K002132 — ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
- K003857 — STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
- K012409 — LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
- K012424 — SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
- K012522 — WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
- K012726 — PROSAFE SAFETY SYRINGE
- K012961 — SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
- K013130 — N LP(A) CONTROL SY
- K013150 — MR-GUIDE 2000
- K013279 — MOSFET AUTOSENSE, MODEL TN-RD-60
- K010032 — SEED SELECTRON MODEL V. 1.0
- K011247 — HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
- K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
- K012278 — THEKEN SMALL CEMENT RESTRICTOR
- K012333 — FLEXI-SITE SP02 EAR SENSOR
- K012403 — VANGUARD REPROCESSED COMPRESSION GARMENT
- K013192 — SONICATOR PLUS 930, MODEL ME 930
- K013236 — LUXABITE
- K011337 — ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
- K011530 — VERTRAN STANDING WHEELCHAIR
- K012254 — VBR
- K012339 — ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
- K012346 — VANGUARD REPROCESSED ARTHROSCOPIC BLADES
- K012482 — STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
- K012499 — ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
- K012542 — REVOTEK LC
- K012559 — POLY STAT HCG TEST
- K012878 — THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
Data sourced from openFDA. This site is unofficial and independent of the FDA.