FDA 510(k) clearances — page 576
clearances on record, most recent first.
Clearances — page 576
57,501–57,600 of 176,542- K080154 — ACUITY UNIVERSAL CUTTER
- K080204 — VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
- K080457 — COLOR LCD MONITOR, MODEL RADIFORCE RX211
- K080482 — ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01
- K080504 — PIONEER LOWTOP SPINAL ROD SYSTEM
- K080518 — PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
- K080563 — RUNTHROUGH NS EXTENSION WIRE
- K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE
- K072036 — ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
- K072527 — AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
- K072702 — STRYKER ANTIMIC CATHETER
- K072891 — SINUS SPACER
- K073095 — TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560
- K073176 — KANTERON DICOM STATION (KDS), MODEL 3.0
- K073293 — DURETTE IMPLANT
- K073635 — SBI SR MTP TOE IMPLANT
- K073698 — SECURE
- K073714 — TRAUMACAD VERSION 2.0
- K073718 — MEDLINE GASTROSTOMY TUBE
- K080025 — LED.L, LED.M, LED.G, LED.B
- K080166 — ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
- K080291 — INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
- K080667 — VARIAX DISTAL RADIUS TORX SCREWS
- K072301 — 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
- K072957 — EVIS EXERA II 180 SYSTEM
- K073361 — MUSCLE PAIN DEVICE (MPD)
- K080391 — DRIVE SOLSTICE OXYGEN CONCENTRATOR
- K080560 — HENKE SASS WOLF OF AMERICA ARTHROSCOPE
- K072686 — AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
- K073274 — SPINAL SPHERE SYSTEM
- K073450 — SUTTER ELECTROSURGICAL CABLES
- K063175 — IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)
- K072307 — QUANTITATIVE NEUROQ 3.0
- K073034 — AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
- K073265 — APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
- K073401 — EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
- K080010 — NOCC HYDROPHILIC WOUND DRESSING
- K080076 — RX DC X-RAY UNIT
- K080130 — OCCLUFAST CAD
- K080211 — MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
- K080280 — SUB-TALAR LOK, MODEL 7-11 MM
- K063787 — INPLEX CF MOLECULAR TEST
- K071120 — AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
- K072864 — ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
- K073260 — LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109
- K073287 — PREVADH MESH
- K073324 — MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
- K073343 — ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX
- K073558 — SENSITITRE 18-24 SUSCEPTIBILITY PLATE
- K073567 — BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
- K073586 — MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
- K073591 — MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
- K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
- K073623 — ATLANTIS 018 PERIPHERAL IMAGING CATHETER
- K073636 — TINNITUS SOUND GENERATOR MODULE
- K080133 — MOUNTABLE ENDOSCOPIC BLADE
- K080393 — MODIFICATION TO REBOUND HRD
- K080394 — BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
- K080407 — BLACKSTONE SFS PARALLEL ROD CONNECTORS
- K080461 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
- K080500 — MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
- K080540 — NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
- K071666 — SLENDERTONE ENERVIVE, MODEL 561
- K072197 — POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR
- K072256 — HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL
- K073023 — STERILS SINGLE-USE I/A HANDPIECES
- K073526 — AMICAS VISION SERIES PACS, MODEL 5.5
- K073538 — DUAL CHAMBER TPN CONTAINER
- K080207 — DANYANG HUAYI K2 AND K7 WHEELCHAIRS
- K080352 — MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE
- K063443 — DRAEGER ALCOTEST 6510
- K073008 — KFH ENERGY, MODEL: E1
- K073041 — RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
- K073064 — GRAFTYS BCP
- K073515 — TRANS1 FACET SCREW
- K073605 — ATRICURE COOLRAIL LINEAR PEN
- K073709 — MODIFICATION TO VIEWMATE SYSTEM
- K080087 — SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
- K080272 — ATLANTIS PVIMAGING CATHETER, MODEL H749364560
- K080423 — INTEGRE, MODEL LP581
- K063157 — MERRIES K-PHATE BONE GRAFT SUBSTITUTE
- K063385 — DUREX PLAY MASSAGE GEL LUBRICANT
- K072425 — JNE IMPLANT SYSTEM
- K073062 — OMNI-VUE SYSTEM
- K073475 — SYSTEM PLUS
- K073484 — ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432
- K080098 — MRJ EXTENDED
- K080120 — HFO SHOULDER COIL
- K080258 — MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
- K080349 — KIMBA MINI
- K080406 — IPULSE, MODEL I400
- K080422 — 5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520
- K071723 — ZIMMER POROLOCK MIS STEM
- K071763 — AMADEUS ADAPTIVE COMPRESSION THERAPY
- K071869 — TENS/IF 14
- K072144 — CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
- K072212 — JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
- K072481 — JET PORT PLUS HP CATHETER SYSTEM
- K072719 — CONVOY ADVANCED DELIVERY SHEATH
- K073028 — VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30
Data sourced from openFDA. This site is unofficial and independent of the FDA.