FDA 510(k) clearances — page 161
clearances on record, most recent first.
Clearances — page 161
16,001–16,100 of 175,699- K210317 — Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System
- K210362 — s-Clean Pre-Milled Abutment
- K210698 — ECOMA Level 2 Disposable Surgical Mask with Ear Loops
- K210749 — Empty EVA Bag
- K211066 — Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3
- K211104 — AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
- K211319 — Purism Non-Sterile Powder Free Nitrile Examination Gloves
- K211328 — EIDON FA, EIDON, EIDON AF, EIDON UWFL
- K211462 — Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask
- K211576 — WYZ Surgical Mask
- K211584 — Oral Surgery Contra
- K211620 — Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
- K212185 — Golden Isles Pedicle Screw System
- K212296 — Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
- K212304 — Callaly Tampliner (super plus absorbency)
- K203227 — Elecsys HCG STAT
- K210318 — Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
- K210971 — EnteraLoc Flow
- K211233 — Hailie Sensor NF0109
- K211454 — Surgical mask
- K211513 — sam X1 Long Duration Ultrasound Device
- K211631 — Surgical Face Mask
- K211813 — Triton
- K211957 — QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
- K212097 — Disposable medical surgical mask
- K212322 — Cellvizio I.V.E. system with Confocal Miniprobes
- K201573 — Brain Perfusion (BP) application
- K203089 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
- K203820 — ASPIVIX v1.1 Cervical Suction Tenaculum
- K210201 — Deep Transcranial Magnetic Stimulation (DTMS) System
- K210998 — ROSA Hip System
- K211376 — STARband
- K211671 — Journey II Mid-Level Tibial Inserts
- K211708 — Disposable Medical Nitrile Gloves
- K201094 — iMap 3D Mapping & Navigation System (iMap System)
- K202636 — Metallic Fabric Electrodes
- K203236 — Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
- K210569 — Disposable Monopolar Laparoscopic Shafts and Reusable Handles
- K210695 — CPM Medical Consultants Tibial Revision Knee System
- K210841 — NuVent Eustachian Tube Dilation Balloon
- K211294 — Multi-Link X2 ECG Cable and Leadwire System
- K211654 — Penumbra System (Reperfusion Catheter RED 72)
- K211703 — Insignia Hip Stem
- K212066 — Adena-Zina System
- K212230 — TruSPECT Radiological Image Processing Station
- K210381 — I.V. Administration Set
- K192823 — MEGA-TMS
- K200913 — Clearblue® Early Digital Pregnancy Test
- K202279 — Insignis Subcutaneous Needle Sets
- K203693 — Nisus Touch Negative Pressure Wound Therapy Pump
- K203817 — Tyber Medical Anatomical Plating System
- K210336 — Neodent Implant System - Zirconia Implant System
- K210671 — Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107
- K210858 — VITROS Chemistry Products PHBR Slides
- K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K211383 — NFLK-2501 Portable X-ray Unit
- K211519 — Every Cycle Reusable Tampon Applicator
- K211563 — Pitch-Patchs
- K211575 — Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
- K211588 — Caretaker Platform, VitalStream Platform, CT5
- K211777 — ARCO FP-S
- K211860 — Powder Free Nitrile Patient Examination Gloves, Blue Color
- K211969 — EMM Ultrasonic Transducer Cover
- K212206 — Jot Dx Insertable Cardiac Monitor
- K212228 — WATCHMAN FXD Curve Access System
- K212229 — White Endoseal MTA
- K201630 — AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
- K203363 — Crosser iQ CTO Recanalization System
- K210327 — First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
- K210510 — Disposable Surgical Gown
- K210661 — SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
- K210912 — Excelsius3D
- K210946 — Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
- K211179 — InferRead CT Stroke.AI
- K211205 — Prase-C Anterior Cervical Plate System
- K211863 — eVolve PACS
- K212007 — VERTICALE Navigation Instruments
- K202536 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate
- K203152 — Disposable Face Mask
- K203448 — uCT ATLAS with uWS-CT-Dual Energy Analysis
- K203643 — Sensatronic Reusable Temperature Probes
- K210687 — CONTOUR® NEXT ONE Blood Glucose Monitoring System
- K210759 — Solo, Swing Maxi
- K211102 — FreeStyle Libre 2 Flash Glucose Monitoring System
- K211353 — Medical Face Mask
- K211552 — Surgical mask
- K211883 — QUANTUM® Patient Specific Instrumentation (PSI) System
- K211993 — Z-LINKPC System
- K212204 — Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
- K201026 — sOLVe Tube
- K210730 — Nitrile Patient Examination Glove
- K210820 — EAGLE EDGE AXR90 and AXR120
- K211414 — KHEIRON Spinal Fixation System
- K211640 — Ponto 5 Mini
- K211799 — Biodentine XP 500, Biodentine XP 200
- K211873 — PSX Interbody System
- K211030 — EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
- K211299 — X-CUBE 70
- K211300 — X-CUBE 90
- K211540 — Edma Synthetic Nitrile Examination Gloves
Data sourced from openFDA. This site is unofficial and independent of the FDA.