FDA 510(k) clearances — page 365
clearances on record, most recent first.
Clearances — page 365
36,401–36,500 of 176,542- K143375 — CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
- K143632 — Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens
- K150122 — TOMTEC-ARENA TTA2
- DEN140020 — ECLIPSE SYSTEM
- K133268 — TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS
- K134046 — FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
- K140900 — PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
- K141087 — INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
- K141222 — NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
- K141328 — QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
- K141803 — IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
- K143055 — Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla
- K143131 — Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
- K143192 — Vanguard 360 Revision Knee System
- K143226 — Visionaire Disposable Instruments
- K143297 — Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)
- K143302 — Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
- K143377 — PedFuse Pedicle Screw System
- K143469 — SOFTECH Plus ETCO2 Cannula
- K143569 — CD HORIZON Spinal System
- K143628 — Navigated Vertex Select Instruments
- K142685 — NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
- K142987 — DD Bio Z, DD Bio ZX(square), DD BioZX(square) color
- K143092 — Tensyn Plug
- K150178 — CD HORIZON SPINAL SYSTEM
- K140980 — TI NASAL MASK
- K141382 — BIOS KING BIOCELLULOSE FILM
- K141911 — OPTIMUS NEURO SYSTEM
- K142472 — Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
- K142716 — VCARE
- K142882 — G7 Freedom and Offset Liners, Freedom Head, Size 32
- K150049 — PASS LP Spinal System
- K150073 — MICRONAIL Distal Radius System
- K150092 — STERISPINE PS Pedicle Screw
- K140949 — ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
- K141421 — PMMA BLOCK
- K142228 — Heated Eye Pad
- K142451 — OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
- K142858 — POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
- K143072 — ENROUTE Transcarotid Neuroprotection System
- K143085 — Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
- K150050 — ACUSON P500 Diagnostic Ultrasound System
- K150062 — Excia Total Hip System
- K142680 — ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT
- K140579 — ULTRASONIC POCKET DOPPLER
- K141492 — ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)
- K142244 — CLEO PATIENT MONITOR
- K142832 — Unimed Disposable and Reusable SPO2 Sensors
- K143044 — CAAS A-Valve
- K143126 — Renovis S141 Lumbar Interbody Cage System
- K143146 — Nexis osteosynthesis snap-off screws
- K143229 — Nexis osteosynthesis compressive screws
- K143257 — KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System
- K143471 — VERTEX Reconstruction System
- K143500 — Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
- K143618 — Kirschner Wires, Steinmann Pins
- K143678 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
- K150028 — Zimmer Segmental System XT Components
- K150145 — MD322C8 31.5 Diagnostic Imaging LCD Monitor
- K141516 — MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
- K141963 — 12SL ECG ANALYSIS PROGRAM
- K141982 — DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K143150 — CO2 monitoring line with and without in-line filter
- K143209 — SonicFill 2
- K143276 — Acumed Small Bone IM Nail System
- K140828 — NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE
- K142880 — DMRC Light Cure Orthodontic Adhesive System
- K143029 — Digital Diagnostic X-ray System (GC80)
- K143172 — ACL SMART System
- K143251 — SIGNA Creator, SIGNA Explorer
- K143402 — Extremity Medical Calcaneal Osteotomy Device
- K150127 — Laparoscopic Handles with peek Insulation
- K131335 — BWMINI EEG, BWMINIHST, BWMINI PSG
- K140575 — ENGSTROM CARESTATION, ENGSTROM PRO
- K141666 — FERTILIGENT SLOW RELEASE IUI CATHETER KIT
- K141945 — ECHOSTAR COMFORT 1.5T MRI
- K142459 — Ebony PTA 0.014 RX Peripheral Dilatation Catheter
- K142767 — ThinkMed Intermittent Catheter with/without Hydrophilic Coating
- K142894 — TCS Blend
- K143200 — MIS Z-Pedicle Screw System
- K143362 — extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
- K143563 — Infusion Aspiration Catheter System
- K142242 — PREMIUM, SHELTA Implant Systems
- K133891 — MULTIPULSE TM+1470
- K140852 — VECTRAPLEX CMS
- K140861 — SOMNOTOUCH RESP
- K141189 — NANOBONE / GRANULATE
- K141354 — NAVAJO PTA BALLOON DILATATION CATHETER
- K141548 — HIGH TIBIAL OSTEOTOMY SYSTEM
- K141751 — ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
- K141986 — ELUX 810 LASER
- K142273 — EmboGuide
- K142957 — Ideal pedicle screw spinal system
- K143171 — FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
- K143178 — FilmArray 2.0 System
- K143179 — The LINK® Endo-Model® Knee System
- K143232 — Universal Digital Interface 2W, UDI 2W
- K143543 — Prelude PF Patellae
- K143633 — CREO Stabilization System
- K134051 — TRANSONIC ELSA SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.