FDA 510(k) clearances — page 342
clearances on record, most recent first.
Clearances — page 342
34,101–34,200 of 176,542- K152678 — TYRX Neuro Antibacterial Envelope
- K152847 — DIVA ZSP5812CMI with QUBYX PerfectLum bundle
- K152848 — AUTOLAP SYSTEM
- K153031 — RANGE/DENALI/MESA Spinal System
- K150504 — GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
- K150609 — Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
- K150612 — Annuy Latex Patient Examination Glove (powdered and powder-free) +1 more
- K150790 — REDAPT Porous Acetabular Shell and Cemented Liner
- K151227 — KYPHON XPEDE Bone Cement
- K151504 — ICS Impulse
- K151605 — Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves
- K151607 — Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
- K151798 — Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
- K151825 — Viradius Neurowire
- K152019 — HairMD
- K152252 — Arthrex iBalance TKA System
- K152255 — BoneCam Suture Anchors
- K152298 — EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base
- K152661 — HICAT Air
- K152740 — Radifocus Glidewire
- K153073 — UroNav (Version 2.0)
- K150353 — BTL-4000
- K150436 — ComboRehab
- K150488 — Humelock II Reversible Shoulder System
- K151275 — MAKO Device
- K151638 — Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
- K151667 — AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
- K151974 — Polaris Spinal System
- K152270 — Denture base resin
- K152277 — PIVOX(tm) Oblique Lateral Spinal System
- K152723 — Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
- K152757 — SIGN Hip Construct (SHC)
- K152928 — Multitom Rax
- K152936 — Sirius Max Dental Diode Curing Light
- K153049 — LithoVue System
- K153075 — Klassic Knee System
- K150298 — Entropy Module, E-ENTROPY-01
- K150358 — Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- K150388 — Dental Implant System
- K150558 — Eclipse System
- K150743 — Water Based Personal Lubricant with Flavours
- K150800 — Valved Safety Centesis Catheter
- K151752 — SOMATOM Emotion 6/16
- K152181 — Turbo-Power Laser Atherectomy Catheter
- K152382 — Arthrex iBalance TKA System
- K152618 — PANTHER Cutter Stapler
- K152623 — ATLANTIS Anterior Cervical Plate System
- K152976 — VLP Mini-Mod Talus Plates
- K152983 — FUJIFILM SonoSite iViz Ultrasound System
- K150211 — EzFuze Implant System
- K150916 — HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
- K151154 — FIBERGRAFT BG Morsels
- K151315 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
- K151819 — Integrity Spine Lumbar Interbody Fusion System
- K151852 — PacEndo Sodium Hyprochlorite
- K152151 — ATAL 9
- K152285 — illumigene Pertussis DNA Amplification Assay
- K152525 — TR BAND Radial Compression Device
- K153058 — CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
- K153060 — Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
- K150397 — Divine 9
- K151382 — Patient Contoured Implant-PEEK (PCI-PEEK)
- K151946 — Thermofit
- K152426 — Wrist - Type Fully Automatic Digital Blood Pressure Monitor
- K152551 — First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.
- K143142 — JDENTALCARE Implant System
- K143693 — MEDLINE SHARPS CONTAINERS
- K150006 — Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing
- K150259 — CLIP PLUS Disposable Clip Applier,ML; CLIP PLUS Disposable Clip Applier,L
- K150268 — CerOX
- K150923 — Breast Pump
- K151209 — InterOss
- K151361 — Nox RIP Belts & Cables
- K151609 — ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
- K151713 — LILLIPUP PMP, LILLIPUT PMP INTEGRATED
- K151759 — Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
- K151903 — Slendertone connect Abs
- K151925 — Elation Wireguided Balloon Dilation Catheter
- K151928 — PUR Dental Implant System
- K152203 — UTERMOHLEN CRYO PROFESSIONAL
- K152567 — Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
- K153023 — Ablatherm Integrated Imaging
- K150102 — SnoreSounds
- K150219 — Equashield Closed System drug Transfer Device (CSTD)
- K150329 — elance Vital Signs Monitor, Central Monitor Software
- K150386 — Tyece OTC TENS Device
- K150688 — IdentEvent
- K150963 — AnsCare ChitoClot Pad
- K151080 — Nihon Kohden CSM 1901 Bedside Monitor
- K151376 — superDimension Navigation System
- K151432 — NaturalLine Abutment
- K151632 — Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
- K151901 — AirView
- K152138 — FDR D-EVO GL Flat Panel Detector System
- K152248 — CD HORIZON Spinal System
- K152256 — RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws
- K152923 — BD ChloraShield IV Dressing with CHG Antimicrobial
- K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
- K143497 — Safety Auto-Disable Syrine with Needle (Auto-Lock)
- K150168 — Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
Data sourced from openFDA. This site is unofficial and independent of the FDA.