FDA 510(k) clearances — page 705
clearances on record, most recent first.
Clearances — page 705
70,401–70,500 of 175,825- K032900 — LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
- K032916 — MIRAGE ACTIVA MASK
- K033190 — VISION-TECH YZ SLIT LAMP, MODEL 66
- K033400 — SENO ADVANTAGE
- K033429 — LAMITRODE SPINAL CORD STIMULATION LEADS
- K033576 — LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
- K033705 — BOBCAT PRO SCALER SYSTEM, MODEL G-130
- K024027 — LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
- K030485 — NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
- K030834 — CANDELA SMOOTHBEAM LASER SYSTEM
- K030895 — ASEPTICO ENDOPEX V, MODEL AEU-40
- K031116 — VECTRA (INTELECT) EPR ULTRASOUND
- K031818 — FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
- K032572 — A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
- K032626 — PERMAQUICK SE BONDING SYSTEM
- K032729 — Z-SERIES MODULAR TOTAL HIP SYSTEM
- K032735 — SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM
- K032752 — R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
- K032988 — ELPHA 4 CONTI
- K033082 — 9 SECOND DIGITAL THERMOMETER, MODEL BT-S09
- K033202 — ADVANTAGE PADDLE
- K033495 — MODIFICATION TO EQUATION FIXATION SYSTEM
- K033510 — MODIFICATION TO TELEGRAPH HUMERAL NAIL
- K033516 — DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
- K033529 — TIE-IN TRAPEZIUM
- K033635 — MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
- K031787 — SMITH & NEPHEW IUR MORCELLATION SYSTEM
- K032488 — WU'S 3-WHEELED NEO SCOOTER, WT-T3D
- K032643 — JUSTWIN SCOOTER, JS-3013
- K032645 — JUSTWIN SCOOTER, JS-3014
- K032762 — XIO RADIATION TREATMENT PLANNING SYSTEM
- K032901 — STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
- K032968 — TRSANSDERM IONTO SYSTEM
- K033031 — TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR
- K033100 — TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01
- K033138 — CAP3 BONE SUBSTITUTE MATERIAL
- K033201 — LA500 BLUE LIGHT
- K033246 — PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
- K033387 — QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
- K033553 — PFZ PORCELAIN SYSTEM
- K023683 — MULTI-STRAP FULL FACE MASK
- K031102 — MICROLAB SPIROMETER
- K031671 — POLARIS WR
- K032696 — AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
- K031374 — BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
- K031826 — TRIHA +
- K032383 — MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
- K032716 — PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)
- K032865 — GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
- K032872 — MICRUS MICROCOIL SYSTEM
- K033370 — POWERED WHEELCHAIR, MODEL FR168W
- K033452 — CWAS 1000
- K033499 — MALIS IRRIGATION MODULE 1000
- K033509 — MODIFICATION TO VERSABOND BONE CEMENT
- K033584 — ARTHROCARE ARTHROWANDS
- K014200 — OPTIMESH
- K030319 — ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
- K031132 — CONSULTIVA CASE INPUT STATION, MODEL CIS-1
- K031524 — GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
- K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
- K032230 — RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
- K032685 — CEMSTOP CEMENT RESTRICTOR
- K032774 — RENOVA INTERNAL HEX IMPLANT SYSTEM
- K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM
- K033059 — HERPES GROUP IGG
- K033064 — MYCOPLASMA IGG
- K033067 — PYLORI IGG
- K033070 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
- K033079 — CHLAMYDIA IGG ELISA TEST SYSTEM
- K033083 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- K033281 — DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
- K033292 — AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
- K033294 — HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER
- K033368 — FOSSA URETERAL OPEN LUMEN STENT
- K033386 — NXSTAGE PUREFLOW SOLUTION
- K033411 — SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS
- K033442 — REFLECTION CONSTRAINED LINER
- K033482 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
- K033561 — FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
- K030802 — CAPHOSOL
- K031153 — MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065
- K031340 — SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO
- K031722 — JSA REPROCESSED COMPRESSION SLEEVE DEVICES
- K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
- K032537 — DRAEGER MICRO2+ AND MASIMO MINISAT
- K033013 — MDIFICATION TO MEDIPRIME
- K033015 — AXIOM BIOLASER LLLT SERIES-3
- K033117 — GRANDIO FLOW
- K033335 — LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
- K033504 — GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
- K033567 — MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
- K033597 — ATR 5000, LC 5000, IMPLANT SYSTEM
- K030263 — IMMUNICON CELLTRACKS ANALYZER
- K031419 — GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
- K032598 — SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
- K032713 — BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
- K032811 — CEDIA VANCOMYCIN ASSAY
- K032874 — HBA SPERM-HYALURONAN BINDING ASSAY
- K033492 — MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
- K033548 — ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.