FDA 510(k) clearances — page 488
clearances on record, most recent first.
Clearances — page 488
48,701–48,800 of 175,770- K102436 — NOBEL ACTIVE 3.0
- K102473 — MULLINS-X PTV CATHETER
- K102609 — KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K102694 — 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
- K102723 — MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
- K102989 — OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS
- K093641 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
- K100668 — NEMA-ST, MODEL V1.0.2
- K101153 — QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
- K101910 — 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS
- K102143 — SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM
- K102367 — OPTIGEN TOTAL KNEE SYSTEM
- K102659 — MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER
- K102739 — HYDROCOLOR 5
- K102965 — CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
- K102984 — AURA
- K103356 — PRUITT CAROTID KIT
- K103367 — SEEKER CROSSING SUPPORT CATHETER
- K100469 — ARCOS INTERLOCKING DISTAL STEMS
- K100709 — EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
- K100739 — VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
- K101401 — NEUMOVENT GRAPHNET MODEL 3179L1V
- K101682 — S 100 PEDICLE SCREW SYSTEM
- K101806 — AIDERA DIASEND SYSTEM
- K101993 — VIPER SYSTEM, EXPEDIUM SYSTEM
- K102095 — SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
- K102103 — SKELETAL DYNAMICS STERILIZATION TRAYS
- K102111 — MEDICAL MAGNETIC TAPE RECORDER
- K102282 — THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES
- K102376 — NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201
- K102422 — SPACELABS MEDICAL PATIENT MONITORS
- K102705 — ARMADA 14 PTA CATHETER
- K102765 — PRONEX
- K093749 — GC AADVA IMPLANT SYSTEM
- K100596 — CRYOPETTE
- K100916 — MEDICON MOGEN CLAMP
- K103099 — PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH
- K103322 — EVERCROSS 0.035 OTW PTA DILATION CATHETER
- K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
- K092587 — BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
- K093565 — PLEURAFLOW CATHETER SYSTEM
- K100040 — BIOHARNESS
- K100126 — STELLATE GRIDVIEW
- K100445 — KLASSIC HD HIP SYSTEM
- K100516 — ANYPLUS PEEK CAGES
- K100731 — BOSWORTH AIR POLISHER
- K100761 — BIOPRO POLAR HEAD
- K100785 — BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
- K100837 — PACENTRIC CONNECT, TRAVELER AND WEB
- K101224 — SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
- K101229 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
- K101267 — PREMIO 10 MOXA
- K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
- K101730 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
- K101835 — MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
- K101907 — HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
- K102209 — ENCODE PATIENT SPECIFIC ABUTMENT
- K102244 — RELIANCE ENDOSCOPE PROCESSING SYSTEM
- K102252 — DMP PIT & FISSURE SEALANT
- K102305 — HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P
- K102313 — PATRIOT TRANSCONTINENTAL M SPACERS
- K102382 — SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT
- K102459 — NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
- K102607 — FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
- K102654 — VERTEX RAPID SIMPLIFIED
- K102688 — MERETE LOCKING BONE PLATE SYSTEM II
- K102812 — GAMMA-BSM; BETA-BSM; EQUIVABONE
- K102818 — MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
- K102854 — PC ECG
- K102867 — IROOT FS
- K102952 — PRODESSE PROADENO
- K103283 — PHYSIOFLOW ENDURO
- K103314 — CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
- K101126 — PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS
- K101577 — MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES
- K102179 — ENVIEW (TM)
- K102352 — EVOLVE EPS ORTHOLOC
- K102399 — CONSENSUS TAPERSET HIP SYSTEM
- K102404 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
- K102525 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
- K102579 — HYPERQ AD-100 SYSTEM
- K102768 — SECRMARK BIOPSY SITE MARKING SYSTEM
- K102830 — ELECTROCARDIOGRAPH
- K102842 — ADHESIVE ELECTRODES
- K103284 — LAMINOPLASY PLATING SYSTEM
- K093908 — CCPOINT
- K100504 — V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
- K101428 — OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
- K101923 — CONCORDE CURVE SYSTEM
- K102035 — SLEEK OTW PTA CATHETERS
- K102514 — NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
- K102536 — VITALA CONTINENCE CONTROL DEVICE
- K102543 — BRAVO PH MONITORING SYSTEM AND ACCESSORIES
- K102587 — LLX240AB01
- K102599 — TOMOPHASE OCTIS
- K102639 — SL3
- K103214 — M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130
- K103313 — HEPARIN ASSAY CONTROLS
- K102638 — DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
- K102682 — STAXX(R) XD SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.