FDA 510(k) clearances — page 636
clearances on record, most recent first.
Clearances — page 636
63,501–63,600 of 175,825- K051435 — ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
- K052004 — VASCON NEUROPATH GUIDING CATHETER
- K052323 — VERSATREK MYCO PZA KIT
- K052357 — PATHWAY - ATS/CHEPS
- K052575 — LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
- K052651 — C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
- K052729 — POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
- K052830 — SPORTMESH
- K052955 — NITRILE BLUE POWDERED EXAMINATION GLOVES
- K052985 — POWDER FREE VINYL EXAMINATION GLOVE
- K053056 — HARMONIC SCALPEL BLADES AND SHEARS
- K053107 — CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
- K053171 — MERIT IMPRESS DIAGNOSTIC CATHETER
- K053292 — DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS
- K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER
- K053350 — MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
- K053433 — CAUTERY TIP CLEANER, MODEL 30500
- K060051 — SPECIMEN RETRIEVAL SYSTEM
- K051145 — CRITIVIEW
- K053158 — OPTILENE MESH LP
- K053161 — SIROLASER
- K053259 — DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE
- K053380 — CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
- K053438 — GLASS CERAMICS
- K053462 — 3160 MRI PATIENT MONITORING SYSTEM
- K053526 — MICROSPEED UNI MOTOR SYSTEM
- K060003 — EXCELART VANTAGE ZGV
- K051566 — PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER
- K052485 — SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF
- K052557 — SUPER SHEATH INTRODUCER SHEATH
- K052570 — TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
- K052642 — SUTURING WASHER
- K053169 — RM3 RENAL PRESERVATION SYSTEM
- K053529 — ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
- K053634 — COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
- K042829 — DBX STRIP
- K050384 — KAPP BARI-RING, MODEL KS-BR-2005
- K052295 — CARDIOSOFT PC ECG, USB VERSION
- K052423 — MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION
- K052453 — TRACTION SYSTEM, DIGIT-TRAC 930
- K052710 — VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,
- K052723 — SEVEN STAR NEEDLE
- K052741 — IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES
- K052919 — MICROSULIS TISSUE ABLATION SYSTEM
- K052935 — HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
- K052976 — DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
- K053004 — MSAS-VANTAGE
- K053110 — Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
- K053153 — RANDOX CALIBRATION SERUM
- K053227 — LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
- K053247 — VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
- K053267 — ENDIUS ATAVI SYSTEM
- K053362 — CELL-CHEX AUTO
- K053427 — FRESH, DENTAL IMPRESSION MATERIAL
- K053436 — SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
- K053460 — MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,
- K053499 — HEMOSIL PROS
- K053501 — POWERPICC
- K053513 — T-PIN
- K053528 — SHORT CITATION FEMORAL STEM
- K053588 — PROFEMUR LX HIP STEM
- K060059 — ALOKA SD-3500 ULTRASOUND SYSTEM
- K052176 — FLOWHANDY ZAN100 USB
- K052920 — DELTA4
- K053049 — ALARIS SAFETY MALE LUER
- K053174 — LOFLO C5 CO2 SENSOR
- K053221 — CDMX-H
- K053283 — UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET
- K052459 — 6248VAL ADJUSTABLE VALVE
- K052970 — SIMPLICI-T ANNULOPLASTY SYSTEM
- K052984 — POWDERED VINYL EXAMINATION GLOVE
- K053130 — ONYX II FINGER PULSE OXIMETER, MODEL 9550
- K053472 — HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
- K051271 — OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR
- K052369 — EXFEEL IMPLANT SYSTEM
- K053106 — TEGO, MODEL D1000
- K053232 — PRECISION BLENDER
- K053502 — NEWPORT E360 VENTILATOR
- K053522 — PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00
- K052556 — CG-7000DX-BT ECG RECORDER/TRANSMITTER
- K052820 — PARAPOST PARACORE AUTOMIX 5ML
- K053425 — PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
- K051031 — AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
- K052548 — UROK ROCKING WHEELCHAIR, MODEL 700-4XX
- K052566 — NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY
- K052619 — THE FINGER GUARD
- K052682 — ALIGNRT
- K052863 — RAPHAEL COLOR
- K052964 — EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
- K053029 — NDR+/DIVA-D
- K053062 — CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2
- K053210 — MAYFIELD SCANMATE MOBILE CT SYSTEM
- K053220 — VERAVIEW IC 5, MODEL XDP1
- K053242 — PITT-EASY DENTAL IMPLANT SYSTEM
- K053322 — MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
- K053326 — ESTECH COBRA ELECTROSURGICAL UNIT & CABLE
- K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
- K053437 — EKOS MICRO-INFUSION SYSTEM
- K053445 — SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
- K053474 — CD HORIZON SPINAL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.