FDA 510(k) clearances — page 192
clearances on record, most recent first.
Clearances — page 192
19,101–19,200 of 175,699- K192481 — AccelFix Lumbar Plate System
- K192681 — Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)
- K200801 — Quantisal Oral Fluid Collection Device
- K200805 — Neocis Guidance System (NGS) with Patient Splints
- K201434 — Connected OR Hub with Voice Control, Connected OR Hub with Device Control
- K201616 — SyMRI
- K201792 — TRUSELECT Microcatheter
- K201794 — Jade
- K200242 — StaClear Syringe
- K200550 — Vitalograph Model 2120 In2itive eDiary
- K200785 — Stratum Reduced Size Foot Plating System
- K201132 — Arthrex Compression Screws
- K201280 — Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
- K192669 — Extremely Thin 003, ZERO ZERO THREE
- K193575 — Arthrex SutureTape
- K193601 — Single Use Electrosurgical Knife
- K193625 — Disposable Temperature Probe
- K200496 — Aer X
- K200643 — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous
- K200742 — JUSHA-CP610 LCD Monitor
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.