FDA 510(k) clearances — page 595
clearances on record, most recent first.
Clearances — page 595
59,401–59,500 of 175,825- K070388 — PROFILE MULTI-PLATFORM SYSTEM
- K070446 — COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL
- K070678 — DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST
- K070713 — IMPLANT LOCATION SOFTWARE-T
- K070726 — NIO COLOR 3MP AND MDNC 3120
- K070750 — 247 BP DEVICE
- K070843 — SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
- K070925 — MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
- K070982 — CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM
- K071017 — IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)
- K062731 — ULTRASONIC SCALER, VARIOS 560
- K063137 — PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000
- K070494 — EPI-C PLUS
- K070628 — OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
- K070637 — FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES
- K070752 — KSEA MINIATURE ENDOSCOPE, MODEL 11565
- K070893 — CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500
- K070902 — MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
- K070906 — MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
- K071028 — VIEWMATE SYSTEM
- K071081 — CONTACT LENS CASE
- K061632 — GLOBUS PREMIUM MUSCLE STIMULATOR
- K061849 — MESODERM
- K062538 — EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
- K062641 — BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
- K063233 — DELTACUT (APPARATUS AND CANNULA)
- K063341 — 3I OSSEOTITE CERTAIN DENTAL IMPLANTS
- K063659 — EASY CURING PEN-STYLE LED CURING LIGHT
- K070178 — AESCULAP RESORBABLE PIN, MODEL FR735
- K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT
- K070321 — TWILIGHT FULL FACE MASK
- K070537 — ZIRBLOCK
- K070552 — DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
- K070714 — MEDISIZE GOLD HEATER AND BOOSTER
- K070772 — PRESSX ZR
- K063038 — FRAXEL III SR LASER SYSTEM AND ACCESSORIES
- K063172 — ARTHROCARE CAVITY SPINEWAND
- K063328 — IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)
- K063503 — OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
- K063695 — RUNTHROUGH NS
- K063779 — OSSEOSPEED 4.0S-6MM, MODEL 24619
- K063783 — PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
- K063808 — FRAXEL IV SR LASER SYSTEM
- K070018 — UNIVERSAL SURGICAL MESH, MODEL 100
- K070410 — COOK MICROWIRE WIRE GUIDE
- K070512 — MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
- K070867 — INOMAX DS (DELIVERY SYSTEM), MODEL 10003
- K070876 — STRYKER TWIST DRILLS
- K071011 — MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
- K071019 — DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
- K063391 — SAPHENEIA CLARITY
- K063582 — ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
- K070249 — ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
- K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
- K070413 — ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028
- K070455 — ZOLL E SERIES WITH SEE-THRU CPR
- K070498 — HYPER SAL
- K070664 — PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
- K070886 — MEROGEL INJECTABLE BIORESORBABLE STENT
- K062332 — ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
- K063380 — ECHOSTIM FACET TIP
- K070374 — ARTHROCARE ENT PLASMA WAND
- K070381 — THEKEN VU MESH VBR SYSTEM
- K070474 — NEWLIFE SCIENCES LLC, MODEL TMR
- K070618 — DICOMPACS, MODEL 5
- K070700 — FREEALGIN
- K070848 — LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X
- K070948 — HSINER NEBULIZER BOTTLE
- K060747 — FX DETACHABLE COIL SYSTEM
- K062834 — OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050
- K063286 — OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE
- K063636 — ZILOS-TK
- K063708 — 4S SPINAL SYSTEM
- K070222 — FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
- K070231 — ORION
- K070311 — CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261
- K070330 — THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
- K070398 — HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
- K070521 — MODIFIED MERCY RETRIEVER, MODEL 90070
- K070535 — RETROPAN CCD-TWAIN-USB
- K070589 — C!
- K070606 — VISIO+CD VIEWER# KPSCDVE01
- K070711 — INCIRCLE BI-POLAR RF ABLATION SYSTEM
- K070776 — SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
- K070839 — MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
- K070879 — BARD MALECOT AND PEZZER DRAINS
- K070896 — ENSEAL PTC TISSUE SEALING DEVICE
- K062105 — DIAZYME CREATININE LIQUID REAGENTS ASSAY
- K063745 — MEDILASER, MODEL 1000
- K063758 — CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
- K063766 — TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C
- K070004 — ACCENT
- K070106 — VV FLUORO 3D
- K070203 — INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
- K070747 — QUICK VUE RSV TEST, MODELS 20193, 20199
- K070958 — MODIFICATION TO ARTHROCARE ARTHROWANDS
- K061815 — COOK CELECT VENA CAVA FILTER
- K062104 — TALKING TRACH
- K070022 — MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9
- K070082 — XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY
Data sourced from openFDA. This site is unofficial and independent of the FDA.