FDA 510(k) clearances — page 157
clearances on record, most recent first.
Clearances — page 157
15,601–15,700 of 176,479- K193138 — Colibri System
- K212716 — Dermoaroma Disposable Nitrile Examination Glove
- K212848 — Sterile Latex Surgical Gloves Powder Free
- K213763 — Sonosite PX Ultrasound System
- K203523 — Fixone hybrid knotless anchor
- K211770 — R3ACT Stabilization System
- K202255 — Skypro, SP02 Mask (3)
- K212921 — Nitrile Examination Golves Powder Free
- K213136 — CPL Surgical Face Mask
- K193407 — Contour® next GEN Blood Glucose Monitoring System
- K202788 — Sonomed IV, Sonomed V
- K203714 — NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty
- K210976 — Curian Campy
- K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb)
- K212088 — Integrity Implants Navigated Instruments
- K212436 — NBR Synthetic Nitrile Examination Gloves
- K213208 — Twist Drills
- K213219 — Vy Spine VyWasher Buttress System
- K213479 — D²RS and D²RS 9090
- K213547 — SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
- K213766 — dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T
- K202404 — BoneMRI
- K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
- K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
- K210147 — Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield
- K210305 — Pulse Oximeter
- K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.1
- K210978 — BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
- K211022 — Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.
- K211691 — Ultrast Gel
- K212285 — Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
- K212310 — EyeBOX (Model EBX-4)
- K212397 — StealthStation S8 Cranial v2.0
- K212603 — Non Absorbable Surgical Nylon Suture
- K212767 — SleepRight Select-Comfort Dental Guard
- K212914 — Glovmaster Nitrile Examination Glove Powder Free
- K213024 — Oren LED Perioral Light Therapy System
- K213094 — ID-500 iRestore Hair Growth System
- K213140 — Claritas iPET
- K213144 — Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
- K213159 — Encore System
- K213207 — Sheath, Stopcock Accessory
- K213225 — Diode Laser System GP900A8, Diode Laser System GP900Q8
- K213411 — iSRobot Mona Lisa 2.0
- K213428 — EdgePro
- K213691 — Solas OR
- DEN210024 — CavaClear Laser Sheath
- K203343 — Wesper Lab
- K203660 — TRI-matrix Implant Line
- K210099 — Meticuly Patient-Specific Titanium Mesh Implant
- K210331 — CardiaMend Pericardial and Epicardial Reconstruction Matrix
- K210670 — BU-CAD
- K210968 — reVive Light Therapy Essentials
- K211078 — Progreat Lambda
- K211086 — The Progen Trochanteric Nail System
- K211109 — N1 TiUltra TCC Implant System
- K211918 — iCOquit® Smokerlyzer®
- K212155 — TheraFace LED
- K212266 — FIX-C PEEK Anterior Cervical Interbody System
- K212613 — Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
- K212690 — qXR-BT
- K212730 — BellaTek Encode Emergence Healing Abutments
- K212770 — Vision
- K212830 — CT3000Pro
- K213006 — Vinyl Examination Gloves
- K213045 — TearCare System
- K213129 — Restoration Modular 115mm Conical Distal Stem
- K213139 — SURGmatic S15 L Pro
- K213301 — InCore Subtalar System
- K213456 — Xenco Medical Multilevel CerviKit
- K213596 — OSSIOfiber Compression Screw, 3.5mm
- K213705 — DRSplus
- K202568 — Mpact® 3D Metal Implants - DMLS Technology
- K203468 — TCAT TKA Instrument Tray
- K203741 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
- K211185 — IPL Home Use Hair Removal Device
- K211521 — 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
- K211750 — Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
- K211842 — Servator M SALF Solution
- K211847 — AdVance XP Male Sling System
- K211865 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K212492 — Frax 1940 for Nordlys and Frax Pro
- K212715 — Vy Spine ClariVy Cervical IBF System
- K212776 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
- K212859 — First Relief
- K213031 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
- K213076 — AspenMed+
- K213275 — EchoGo Core (2.0)
- K213531 — TR BAND Radial Compression Device
- K210559 — ATOZ Mini-Screw
- K211457 — Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
- K211624 — USA Gloves Nitrile Powder Free Exam Gloves
- K212932 — Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray
- K213048 — Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
- K213051 — Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
- K193081 — Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
- K200943 — Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System
- K203424 — Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2
- K203695 — NObreath®
- K203821 — Donagamex Blue Performance Protective Gown
Data sourced from openFDA. This site is unofficial and independent of the FDA.