FDA 510(k) clearances — page 482
clearances on record, most recent first.
Clearances — page 482
48,101–48,200 of 176,542- K111163 — CHITOGAUZE FUSION
- K111321 — REMOTE VIEW SOFTWARE
- K100130 — PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
- K101779 — CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
- K102535 — ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
- K102887 — ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
- K110303 — STRATUS CS ACUTE CARE D-DIMER
- K110415 — SIGNATURE PLANNER / SIGNATURE GUIDES
- K110510 — S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
- K110986 — OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
- K111243 — FUJINON ULTRASONIC PROCESSOR
- K100987 — INVADER MTHFR 677
- K102328 — BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
- K102510 — DIMENSIONS HB1C KIT, MODEL DF105A
- K102598 — HI-DOW-XP
- K102619 — COMPUTED RADDIOGRAPHY SCANNER
- K102748 — 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T
- K102845 — MAHE FIXATION PLATE AND SCREW SYSTEM
- K103025 — GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
- K103407 — COTRONIC DIGITAL THERMOMETER
- K103473 — ZOLL RESCUENET EPCR MODEL RESCUENET EPCR
- K103545 — BT-350
- K103589 — NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
- K103635 — CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
- K110102 — POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
- K110146 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
- K110225 — ANGIODYNAMICS, INC. VENACURE 1470 LASER
- K110235 — BEAUTIBOND MULTI
- K110252 — BEAUTIBOND MULTI PR PLUS
- K110449 — ENDOBON XENOGRAFT GRANULES
- K110454 — COUGAR LS LATERAL CAGE SYSTEM
- K110540 — TERUMO SUPPORT CATHETER
- K110771 — BD SINGLE USE, HYPODERMIC SYRINGE
- K110774 — ELECTRONIC SPHYGMOMANOMETER
- K110775 — ELECTRONIC SPHYGMOMANOMETER
- K110853 — VR MEDICAL ENTERAL ORAL SYRINGE
- K110948 — HEALTH CARE SYSTEM SOFTWARE
- K110978 — ONESTEP PEDIATRIC MFE'S
- K111079 — SYNGO.VIA WEB VIEWER
- K111121 — VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
- K111227 — ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
- K111234 — CLICK-IT
- K111257 — HEISENBERG DYEING LIQUIDS
- K101155 — AURADORM (NEUROMUSCULAR SLEEP)
- K102026 — SEASPINE SPACER SYSTEM
- K103211 — AVEA VENTILATOR
- K103312 — UPD-Y0003
- K103716 — ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
- K103744 — DROPPER A1C DIABETES CONTROL
- K110122 — MUSTANG BALLOON DILATAION CATHETERS
- K110159 — ACTIVECARE SFT
- K110433 — CLEARBLUE EASY PREGNANCY TEST
- K110613 — ELECSYS PROLACTIN II CALCHECK 5
- K110628 — SIMPLEABI
- K110692 — STREAMLINE TL SPINAL SYSTEM
- K100910 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
- K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
- K103525 — A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
- K103633 — ACHILLES
- K110409 — ASPIRA PLEURAL DRAINAGE SYSTEM
- K110413 — POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
- K110430 — DOLPHIN IMAGING
- K110528 — INTEGRA LED SURGICAL HEADLIGHT SYSTEM
- K110965 — RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
- K100567 — PEARL DIABETES MANAGEMENT SYSTEM
- K101585 — K-Y BRAND LONG LASTING VAGINAL MOISTURIZER
- K102725 — CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M
- K102788 — TORNIER BIOFIBER SCAFFOLD
- K102860 — ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
- K103718 — DYNACOR LUBRICATION GEL
- K110121 — WEXLER ENDOSCOPE ACCESSORIES
- K110314 — STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)
- K110386 — CELOX RAPID GAUZE
- K110399 — GLADIATOR PLASMA CLASSIC HIP STEM
- K110450 — AGILIS NXT STEERABLE INTRODUCER
- K110996 — BAHA 3 POWER SOUND PROCESSOR
- K092266 — RANDOX METHAMPHETAMINE ASSAY
- K101763 — DIOPSYS NOVA VEP VISION TESTING SYSTEM
- K102182 — MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
- K103611 — UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
- K110751 — CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
- K100263 — ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
- K101158 — LIC INSTRUMENT PROCESSING SYSTEM
- K102141 — COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
- K102208 — NANOGEN
- K102568 — URIC ACID MODEL 3P39
- K102913 — FORCETRIAD
- K103174 — APEX MEDICAL WIZARD SERIES CPAP MASK
- K103364 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
- K103510 — UNIMAX SPECIMEN RETRIEVAL SYSTEM
- K103730 — GE LUNAR VISCERAL FAT SOFTWARE
- K103771 — LOTUS BLAKE ESTEEM SCOOTER
- K110257 — DIAMOND-FLEX(R) GRASPERS
- K110369 — INDISTRIP GREEN
- K110396 — ASPIRA PERITONEAL DRAINAGE SYSTEM
- K110788 — INNOVA WHEELCHAIR
- K111015 — STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
- K111164 — EUNITY
- K094013 — HLS KNEETEC SYSTEM
- K102263 — HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.