FDA 510(k) clearances — page 319
clearances on record, most recent first.
Clearances — page 319
31,801–31,900 of 175,699- K153553 — SiO2 Coated syringe 3 ml
- K153716 — GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
- K160356 — Third Eye Panoramic Auxiliary Endoscopy System - Resposable
- K160480 — PicoSure Workstation
- K161080 — Escalade Legend Acetabular Shell
- K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers
- K152754 — COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
- K153396 — Aesculap OrthoPilot Next Generation
- K153683 — Trak Male Fertility Testing System
- K160090 — Lumipulse G ROMA
- K160280 — MagPro R20
- DEN140032 — Cereve Sleep System
- K152020 — Bindex BI-100
- K152068 — Astral 100/150
- K152353 — SeraQuest HSV Type 2 Specific IgG
- K152510 — UltraCor Twirl Breast Tissue Marker
- K153045 — SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
- K153236 — Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
- K153490 — DD medical polymers
- K153563 — AirFit F20
- K160057 — ArcCHECK-MR
- K160154 — ALTA Anterior Cervical Interbody Spacer
- K160240 — Perimeter Otis 1.0 Optical Coherence Tomography System
- K160380 — LT-300 HD
- K160710 — Oasis Lacrimal Intubation Set
- K161057 — Diagnostic Imaging Color LCD Monitor
- K161117 — EzDent-i / E2 / Prora View
- K161119 — SonoSite iViz Ultrasound System
- K150980 — Venous Assist System
- K152630 — VERIFY STEAM Integrating Indicator
- K152745 — ReNew Sterilization Trays(Catalog #3708 and #3709)
- K152749 — moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
- K153239 — LSFG-NAVI
- K153316 — Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
- K153670 — Genteel Lancing Device
- K153703 — Guiding Catheter
- K160254 — GORE DrySeal Flex Introducer Sheath
- K160419 — Monoject Enteral Feeding Syringe with ENFit Connector
- K161046 — Laser Helmet LH40-EVO
- K152429 — Slit Lamp Microscope
- K152443 — Vericore Gradient Temporary Disc
- K152825 — Catalyst CSR Shoulder System
- K161000 — Biodesign Otologic Repair Graft
- K152679 — Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
- K153657 — Vanguard XP Knee System
- K160242 — Reprocessed Livewire Steerable Diagnostic EP Catheter
- K160303 — Reprocessed Polaris X Steerable Diagnostic EP Catheter
- K160319 — FiberTak DR
- K152431 — LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
- K153350 — IBS Implant System
- K161017 — True HD 3MOS Camera System
- K152043 — Diagnostic Station DS20
- K152205 — Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
- K152415 — Digital Blood Pressure Monitor
- K152680 — TD-1035 Thermometer
- K152717 — Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
- K152769 — FREMAP ELECTRODE
- K152911 — EarlySense Insight Sytem
- K152956 — Pulp Canal Sealer, Pulp Canal Sealer EWT
- K153008 — INVISION Total Ankle Revision System
- K153111 — TOUAREG CloseFit UNP 2.75mmD
- K153139 — Achieve ST Mapping Catheter, Catheter Connecting Cable
- K153506 — Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit
- K153615 — NeoFuse HA Enhanced PLIF/TLIF
- K160053 — Monopolar single-use HF cable
- K160740 — Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
- K150364 — ERBE ESU Model VIO dV with Accessories
- K151362 — HC Spinal System
- K152006 — Cogent Hemodynamic Monitoring System
- K152682 — Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit
- K152930 — PeriFlux6000
- K153520 — Electronic Pulse Stimulator
- K153585 — Flip Button Suture Anchor
- K153620 — Enovare Ultrasound System
- K160324 — Cervical Interbody Fusion System
- K160428 — Certex Spinal Fixation System
- K160951 — Philips Efficia CMS200 Central Monitoring System
- K160952 — Alma Diode Tabletop Laser
- K161021 — HydroMARK Breast Biopsy Site Marker
- K161047 — LOGIQ P9 and LOGIQ P7
- K153277 — 6200 Ultrasound System and 6250 Ultrasound System
- K153783 — SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
- K160006 — Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit
- K160503 — Vented Vial Adapter Transfer Device - 13mm
- K160568 — Precision Spine Interspinous Plate System
- K160639 — Electrosurgical Generator ESG-200
- K160654 — GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
- K160773 — Yarlap II
- K160936 — Certus 140 2.45GHz Ablation System
- K160986 — Xenco Medical Pedicle Screw System
- K161203 — Soehendra Stent Retriever
- K152029 — HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
- K152908 — UCP COMPACT DRUG TESTS
- K153720 — ENZA Zero-Profile Anterior Interbody Fusion
- K160050 — SERFAS 90-S Electrosurgical Probe
- K160084 — Swan Ganz Catheters
- K160118 — STROPP (Single Tunnel Repair of Plantar Plate)
- K160845 — Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
- K160922 — FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)
- K151390 — Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
Data sourced from openFDA. This site is unofficial and independent of the FDA.