FDA 510(k) clearances — page 569
clearances on record, most recent first.
Clearances — page 569
56,801–56,900 of 175,825- 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
- K073161 — REPLUS DENTAL IMPLANTS (HA)
- K073247 — US/SS/GS SYSTEM
- K073286 — GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
- K073345 — CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT
- K073374 — COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
- K073476 — COMPACT AUTO-SAFETY INJECTOR (CASI)
- K073488 — DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
- K073506 — LUMINEX LX 100/200 INSTRUMENT
- K080286 — CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS
- K080318 — ALMA LASER NIR MODULE
- K080387 — HU II / HS II FIXTURE SYSTEM
- K080415 — DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K070800 — LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
- K071242 — DBEST ONE STEP OCCULT BLOOD TEST KITS
- K072163 — HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
- K072214 — PORTABLE VENTILATOR, MODEL EPV-100
- K072421 — K-Y BRAND YOURS+MINE
Data sourced from openFDA. This site is unofficial and independent of the FDA.