FDA 510(k) clearances — page 510
clearances on record, most recent first.
Clearances — page 510
50,901–51,000 of 175,825- K100048 — E1 ANTIOXIDANT INFUSED TECHNOLOGY
- K100500 — PSL CLASSIC SLIT LAMP
- K093585 — MICROCYN SKIN AND WOUND HYDROGEL
- K093788 — INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
- K100020 — DX SERIES FINGER SENSOR
- K090050 — STEREOS WORKSTATION
- K090123 — NEONATAL BIOTINIDASE KIT, MODEL 3018
- K090753 — THERATEST EL-ANTI-CCP/2
- K092211 — CHESAPEAKE SPINAL SYSTEM
- K092326 — SMOOTHCOOL
- K092424 — P-ART, MODEL 001
- K092460 — STAR-LITE -LM, MODEL SL8809
- K092538 — REFINE SUPPORT SYSTEM, MODEL 100.0100
- K092740 — ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
- K092907 — DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR
- K092940 — COAGUCHEK XS PLUS PST SYSTEM
- K093324 — EMPI CONTINUUM
- K093336 — INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM
- K093380 — MIZZY EXPRESS
- K093480 — CUATTRO UNOMD
- K093575 — GLUMA DESENSITIZER POWER GEL
- K093624 — OPTISCAN MODEL OPTISCAN CEIS
- K093645 — EXL ANEM CAL, MODEL RC640
- K093677 — STRYKER ARTHROSCOPE
- K093761 — OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM
- K093842 — 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
- K093943 — BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM
- K093969 — ACUITY BREAK-AWAY GUIDE CATHETER
- K094017 — TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
- K100058 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K100328 — CLEARFIL MAJETY POSTERIOR
- K100402 — SITE-RITE VISION ULTRASOUND SYSTEM
- K100446 — CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE
- K083186 — AESCULAP HYDROLIFT VBR SYSTEM
- K091732 — VRLXP, MODEL XP
- K092148 — HAMILTON-C2
- K092366 — TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE
- K092857 — VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS
- K092905 — AUTOSTART BURETTE
- K093127 — TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET
- K093210 — AQUALASE CAPSULE WASH TIP
- K093306 — SINGLE-PATIENT USE DISPOSABLE SENSOR
- K093388 — SMART CAPNOLINE GUARDIAN
- K093508 — RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
- K093523 — MICRO-TOUCH NITRILE
- K093552 — EVOLUTION MP TOTAL KNEE SYSTEM
- K093576 — RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
- K093612 — SYNGO.PLAZA
- K093615 — SPI DENTAL IMPLANT, ELEMENT
- K093700 — ELECSYS HCG STAT CALCHECK 5
- K093702 — REPROCESSED ULTRASONIC COAGULATING SHEARS
- K093897 — SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
- K100016 — AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7
- K100297 — PASS LP SPINAL SYSTEM
- K090658 — SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
- K091208 — GS III SYSTEM
- K092331 — DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;
- K092613 — COLOR LCD MONITOR, MODEL RADIFORCE RS210
- K092675 — GRINDCARE
- K093194 — MGB DISPOSABLE RETRIEVAL BAG LAPBAG
- K093258 — BLOM-SINGER INDWELLING TEP OCCLUDER
- K093273 — VIT KIT - FREEZE AND THAW
- K093559 — VINTAGE MP
- K093594 — MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
- K093757 — MD300C1 FINGERTIP PULSE OXIMETER
- K093812 — ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
- K093894 — ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
- K100413 — TEMP IT
- K100468 — ZEISS INFRARED 800 WITH FLOW 800 OPTION
- K091025 — CHROMID VRE AGAR, MODEL: REF 43 851
- K091688 — A-GRIX RESORBABLE BONE VOID FILLER
- K091967 — MEDACTA BIPOLAR HEAD
- K092902 — U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC
- K093126 — ANAPNOGUARD ENDOTRACHEAL TUBE
- K093717 — C-MOR VISUALIZATION DEVICE
- K093764 — SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM
- K082823 — HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
- K091634 — NMI FC
- K092244 — MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
- K092494 — GEL FILLED GUM SOOTHER
- K092842 — ECHOPLAQUE
- K093155 — VASHE WOUND CLEANSING SYSTEM
- K093414 — PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
- K093719 — PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
- K100079 — DIGITAL ULTRASOUND SCANNER
- K100386 — DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
- K083876 — SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT
- K091188 — ASAHI ZENYTEEX GUIDING CATHETER
- K092733 — PYTON
- K092947 — TELESENTRY, MODEL TS01
- K092965 — TRAILRUNNER GUIDEWIRES
- K093174 — SPIROPALM
- K093203 — CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841
- K093209 — FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
- K093463 — AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
- K093684 — EASYCARE ONLINE
- K093796 — ASEPT PERITONEAL DRAINAGE SYSTEM
- K100074 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K100075 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
- K100282 — TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.