FDA 510(k) clearances — page 368
clearances on record, most recent first.
Clearances — page 368
36,701–36,800 of 175,770- K142636 — Merit 10mL Syringe
- K142660 — Antegrade LeMills Valvulotome
- K133390 — NDX DORSAL APPLIANCE
- K133488 — PIEZOMED
- K133677 — SYNGO CT SINGLE SOURCE DUAL ENERGY
- K140023 — ELEVATION
- K140543 — PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
- K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC
- K141584 — ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
- K141753 — AQUARIUS NASAL FEEDING TUBE
- K141801 — HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
- K142184 — DX-D IMAGING PACKAGE
- K142280 — Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
- K142618 — Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System
- K142653 — G-Lok and G-Lok XL Extender
- K131987 — MULTIPULSE HOPLUS
- K134009 — UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
- K140025 — AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
- K140470 — OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER
- K141776 — STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
- K141865 — DANA
- K141954 — XCEL 455 SLIT LAMP
- K142095 — RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
- K142193 — COGENT MED-LIF XL
- K142346 — Urine/CSF Albumin, Urine/CSF Albumin Calibrator
- DEN130044 — INFLOW INTRAURETHRAL VALVE-PUMP
- K142277 — JULIET PO
- K142616 — PICC Maximal Barrier Nursing Kit
- K131925 — HS NOTA
- K133441 — ONESTEP CPR II MULTI-FUNCTION ELECTRODE
- K140120 — EPIC 10
- K140463 — INTEGRA EXTERNAL FIXATION SYSTEM
- K140619 — MECA XPRESSFISH
- K140938 — OSTOM-I ALERT
- K141106 — FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
- K141399 — FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
- K141869 — QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
- K142014 — SOFIA DISTAL ACCESS CATHETER
- K142033 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
- K142037 — QUANTRA
- K142160 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
- K142323 — Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
- K142614 — AngioDynamics VenaCure EVLT Tre Sheath and VenaCure EVLT NeverTouch Procedure Kits
- K142628 — Acuson SC2000 Diagnostic Ultrasound System
- K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
- K133990 — IEVA REHABILITATIVE POSITIONAL DEVICE
- K140319 — COROENT TI-C SYSTEM
- K140805 — ITCLAMP 50
- K141416 — BLOOD PRESSURE MONITOR
- K141659 — PRISM ZIRCONIA, ST-98
- K141791 — BIOMET FUSION SYSTEM
- K141927 — LYRA PARAINFLUENZA VIRUS ASSAY
- K141931 — LYRA ADENOVIRUS ASSAY
- K141972 — KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY
- K142396 — Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
- K131487 — FLUOR PROTECTOR S
- K133245 — GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM
- K140249 — LONG PULSE ND: YAG LASER SYSTEM
- K141201 — A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR
- K141326 — NEEDLE VIEW CH SCOPE KITS
- K141378 — IDC INTERLOCKING DETACHABLE COIL
- K141456 — THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
- K141855 — CLARITY
- K142198 — BNX Fine Needle Aspiration System
- K142515 — MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra
- K133040 — LED CURING LIGHT
- K140304 — SIMPLY SLICK PERSONAL LUBRICATING LOTION
- K140467 — FLEX-MT +
- K141160 — A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR
- K141510 — EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
- K141623 — EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
- K141699 — VASSEN COLOR
- K141739 — RESIDUAL LIMB LENGTHENING SYSTEM
- K142027 — 888 WNLE POWERED WHEELCHAIR
- K142275 — Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
- K142353 — First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
- K141522 — APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
- K141704 — NOVASHIELD INJECTABLE NASAL PACKING AND STENT
- K141708 — ULTRASHAPE SYSTEM
- K141842 — STARBAND, STARLIGHT
- K141894 — SHARKCORE FINE NEEDLE BIOPSY SYSTEM
- K141973 — DIODE LASER HAIR REMOVAL SYSTEM
- K142538 — LiNA SafeAir Smoke Pencil
- K133975 — MSA100 PEAK FLOW METER
- K140062 — FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
- K140309 — CRANIOPLUG
- K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC
- K141139 — SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
- K141297 — FORUM GLAUCOMA WORKPLACE
- K141502 — HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
- K141743 — FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
- K141765 — FDR D-EVO FLAT PANEL DETECTOR SYSTEM
- K142304 — Viberect Penile Vibratory Stimulation Device
- K142442 — MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
- K142466 — UGEO PT60A Diagnostic Ultrasound System
- K142534 — HyProCure II
- K142536 — 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
- K142540 — 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
- K140530 — Electro Auricular Device
- K140908 — JUGGERKNOT MINI SOFT ANCHOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.