FDA 510(k) clearances — page 654
clearances on record, most recent first.
Clearances — page 654
65,301–65,400 of 176,637- K051629 — BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
- K051762 — SAF-T-SYRINGE/SAF-T-NEEDLE
- K051835 — NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702
- K051859 — SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM
- K051978 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
- K052056 — DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM
- K052123 — SYNTHES PANGEA SYSTEM
- K052245 — ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS
- K052376 — MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
- K052402 — VERTEX RECONSTRUCTION SYSTEM
- K052554 — MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
- K051787 — TRIAGE BNP TEST, MODEL 98000XR
- K052047 — ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
- K052134 — CYSTOGLIDE DILATING INTRODUCER SHEATH
- K052199 — 21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)
- K052315 — SIMTEC IM-MAXX 2 OPTION
- K052372 — MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
- K052410 — ACUSON SEQUOIA ULTRASOUND SYSTEM
- K052461 — SYNGO IMAGING VERSION V20A
- K050807 — 20G SMA LASER FIBER, MODEL LF100
- K051494 — MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
- K051540 — INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
- K051678 — SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM
- K051697 — SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
- K051938 — TRITON/TRU-TRAC/TX TRACTION DEVICES
- K051957 — REPROCESSED EXTERNAL FIXATION DEVICE
- K051988 — OXY-SERVE II OXYGEN CONSERVING REGULATOR
- K052091 — SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
- K052239 — EBI DYNAFIX VISION FOOTPLATE SYSTEM
- K052274 — GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000
- K052276 — NIO 2MP-20 AND E-2620 S
- K052293 — GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
- K052317 — MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
- K052329 — WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
- K052332 — AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER
- K052411 — HIPAX MEDICAL IMAGING SOFTWARE
- K052441 — GE LOGIQ 7 ULTRASOUND BT05
- K052447 — SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
- K052452 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
- K052460 — POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE
- K051259 — VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
- K051291 — NON-STERILE SURGICAL MASK
- K051357 — DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH
- K051440 — MAYFIELD INFINITY SKULL CLAMP
- K051782 — BLUEPHASE 16I
- K051873 — DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
- K052282 — VENAFLO II VASCULAR GRAFT
- K052419 — MAXIMUS 3.0 AND OS IMPLANTS
- K052444 — INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
- K051552 — O.A.S.I. SYSTEM
- K051750 — FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
- K051397 — BIOBANDS
- K051830 — NEURODRIVE SYSTEM
- K051885 — MBCP
- K052008 — IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7
- K052412 — INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
- K051260 — SCHUCO MIST AND SCHUCO DELUXE MIST
- K051313 — BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
- K051461 — 3I OSSEOTITE DENTAL IMPLANTS
- K051718 — NUVASIVE NEUROVISION JJB SYSTEM
- K051857 — VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221
- K051997 — CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
- K052382 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K052403 — CORONIS 2MP-21 AND MFGD 2621
- K052429 — CORONIS 3MP-21 AND MFGD 3621
- K050085 — OSTEOPAL V
- K050382 — AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM
- K050524 — EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
- K050729 — ALCON MULTI-PURPOSE DISINFECTING SOLUTION
- K051366 — PICONIBP OEM MODULE
- K051852 — SINGLE AMPLIFIER FOR BOTOX
- K051922 — ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
- K052084 — ENDO-EASE ENDOSCOPIC OVERTUBE
- K052211 — DUREPAIR DURA REGENERATION MATRIX
- K052247 — NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX
- K052248 — DORSAL NAIL PLATE, ANATOMICAL
- K052324 — POLARIS LV, LVA APPLICATOR
- K052325 — CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
- K052344 — COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C
- K052345 — ADVANTAGE SIM MD
- K052355 — AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
- K052454 — THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM
- K050760 — ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
- K051749 — COBRA SURGICAL SYSTEM
- K051899 — BD PEN NEEDLE
- K052030 — SURGEON'S GLOVE, POWDER FREE
- K052048 — ACCORDION
- K052152 — B-BOP PLATE
- K052214 — PRE-POWDERED STERILE EXAM GLOVES
- K052217 — CRONO SUPER PID
- K052219 — CRONO GO.
- K051565 — PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA
- K051655 — ANGIODYNAMICS, INC., MICRO ACCESS KITS
- K051825 — COGNITRACE
- K052015 — DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
- K052031 — POWDERED LATEX SURGEON'S GLOVE
- K052205 — CAPIOX AF125X ARTERIAL FILTER
- K052224 — BD PROBE TEC URINE PRESERVATIVE TRANSPORT
- K052302 — HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
- K033231 — SPINA SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.