FDA 510(k) clearances — page 200
clearances on record, most recent first.
Clearances — page 200
19,901–20,000 of 176,479- K200849 — Tempus LS - Manual
- K200927 — Transept Cervical Plate System
- K201293 — Ureterorenoscope System
- K201321 — DePuy Synthes 2.7mm VA LCP Clavicle Plate System
- K201479 — DemeMASK
- K193450 — Pre-Seed Fertility Lubricant
- K193520 — EVA 15 Insufflator
- K200090 — PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
- K200464 — LG Pra. L Derma LD Scalp Care
- K200738 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K200743 — Vivid E80/ Vivid E90/ Vivid E95
- K201083 — Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors
- K201122 — Canon non-mydriatic retinal camera CR series
- K201713 — AVVIGO Guidance System
- K201796 — 1717SCV, 1717SGV
- K192511 — Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm
- K192998 — Reprocessed BRK Transseptal Needle
- K193277 — SOMATOM On.site and On.scene
- K193528 — Empty EVA Bag
- K200355 — Duranext Abutments
- K200513 — DAC Dynamic Active Compression Plate
- K200621 — Caption Interpretation Automated Ejection Fraction Software
- K200654 — Rubicon SA System
- K200836 — 8ch Flex Suite
- K200869 — Gamma3 System
- K201150 — InMode RF Multi-System
- K201200 — Visera Elite II Video System Center
- K201355 — Endomat Select, IBS Shaver Software, License
- K201406 — Picowon
- K201527 — EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
- K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
- K201751 — Pedicle Screw System
- K201780 — True Tulip System, True M.I.S. System
- K192847 — AUTOLIGN
- K193434 — VITA LUMEX AC
- K193607 — BOBBY Balloon Guide Catheter
- K200383 — Wiggins Medical Surgical Instruments
- K200387 — Ace Medical Surgical Instruments
- K201689 — Riptide Aspiration System
- K201690 — Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire
- K191875 — Owgels Oxygen Concentrator
- K192366 — Intravascular Extension Sets and Accessories
- K193022 — Retractable Safety Insulin Syringe
- K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
- K193392 — BioSiCar Silicone Implant
- K193603 — Benesta Medical Sterilization Tray
- K201179 — GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
- K201349 — Smith+Nephew Arthroscopes
- K192793 — Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
- K193204 — Cryocheck Chromogenic Factor VIII
- K193526 — Syringe with safety needle, Safety needle
- K200063 — AeroEclipse* ONE BAN
- K200498 — SCENARIA View
- K200542 — Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
- K200680 — Synvitro Hyadase
- K200818 — 3DMax MID Anatomical Mesh
- K201098 — Ambu Duodeno System
- K201198 — S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
- K201227 — Phantom® Hindfoot TTC/TC Nail System
- K201364 — LINK TrabecuLink Femoral Cones
- K201365 — True 3D Viewer
- K201465 — SuRgical Planner (SRP) BrainStorm
- K201488 — Rover
- K201672 — Signia Stapler (with new software)
- K201798 — myQA iON
- K191449 — ZCA All-Poly Acetabular Cups
- K191698 — TiN Coated Humeral Head
- K192386 — KeraStat Cream
- K193456 — Arm Blood Pressure Monitor
- K200497 — Vivid S60N, Vivid S70N
- K200578 — Infrared Thermometer Model Number RN-50A,RN-50B
- K200655 — FibroScan® 630
- K200905 — HealthMammo
- K201272 — Geneva
- K201660 — KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
- K201662 — REDUCT® Headless Compression Screw System
- K201663 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
- K201676 — Barricaid Instrument Tray
- K191146 — Humelock TiN Coated Glenosphere
- K200531 — iHealth Infrared No-Touch Forehead Thermometer
- K200690 — LifeSignals ECG Remote Monitoring Patch Platform
- K201005 — FullFocus
- K201018 — Encision AEM enTouch 2X Scissor
- K201064 — V30 System, V20 System, V10 System, V-FR Handpiece
- K201080 — Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
- K201109 — CO2 Laser Therapy System
- K201149 — CoLink Plating System
- K201234 — BD SoloShot Mini Syringe/ BD Auto Disable Syringe
- K201605 — EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage
- K201614 — TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
- K201618 — Nalu Neurostimulation SCS system
- K201621 — Magicore II System
- K193063 — EMBOTRAP III Revascularization Device
- K193097 — Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
- K193515 — Mako Total Knee Application
- K200325 — Orbit Subretinal Delivery System
- K192561 — TRAUS SUS20
- K200218 — Digiscan FDX
- K200960 — Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
- K201000 — Biodesign Staple Line Reinforcement
Data sourced from openFDA. This site is unofficial and independent of the FDA.