FDA 510(k) clearances — page 56
clearances on record, most recent first.
Clearances — page 56
5,501–5,600 of 175,620- K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
- K241981 — Change Healthcare Stratus Imaging PACS
- K242018 — UbiqVue 2A Multi-parameter System (UX2550)
- K242173 — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
- K242420 — pNOVUS 21 Microcatheter
- K242430 — Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)
- K242502 — Aurelia Surgical Mask ASTM Level-3 (2130)
- K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
- K242791 — Electric wheelchair (KR-8807)
- K241575 — Straumann® Anatomic Healing Abutments XC (AHA)
- K243233 — esolution® Esophageal Retractor
- K240417 — ProFound Detection (V4.0)
- K240510 — Microdacyn Hydrogel
- K240794 — Frontier X Plus
- K241099 — Plasonic (Plasonic)
- K241342 — Hair Growth Comb (SZ-23,SZ-23A)
- K241364 — Hybrid Viewer (00859873006189)
- K241636 — MobileLink Acetabular Cup System - Line Extension (Multiple)
- K241802 — Device 300397 Putty
- K242231 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
- K242286 — Superflow Prime Treatment System (ASP-1M)
- K242382 — décoLITE LED Device
- K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent
- K242756 — Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)
- K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
- K243004 — Xpine Spinal Fixation System
- K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
- K243231 — Trigon PEEK HA Wedges
- K212425 — MicroTrend System
- K240415 — Newclip Patient-matched instrumentation non sterile PSI
- K240429 — Trilogy Tissue Marker
- K240712 — icobrain aria
- K241346 — IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
- K241468 — Vertiwedge® Intraosseous System
- K241719 — NeuroICH
- K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve
- K241872 — Remanufactured EndoWrist ProGrasp Forceps (420093)
- K242361 — OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI
- K242367 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K242373 — Mako Shoulder Application (1.0)
- K242379 — LL Implant System
- K242595 — Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
- K242702 — VioSeal
- K242734 — ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System
- K240450 — Citrepore
- K240831 — MultiCut Solo
- K240997 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- K242039 — Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
- K242261 — Accelx Implant System
- K242412 — Agility Symmetric Total Knee System
- K242719 — ELEXIR 2.0 (ALLIVE3)
- K242803 — Compound W Skin Tag Remover
- K243222 — BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
- K231287 — POTENZA
- K240624 — InfuLife
- K241312 — TeraRecon Cardiac.Chambers.MR (1.0.0)
- K241484 — Atlas Humeral Nail System
- K241849 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
- K242332 — Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
- K242340 — DESS Dental Smart Solutions
- K242345 — Delphi Stimulator
- K242664 — gentleheel® Adult Incision Device
- K242947 — FreedomFlow Orbital Circumferential Atherectomy System
- K243015 — Skyway Anterior Cervical Plate System
- K243106 — CarboClear® Hybrid Pedicle Screw System
- DEN230083 — Valeda Light Delivery System
- K240438 — CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)
- K240512 — Tixel i (TXLI0001)
- K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel
- K242195 — Gemini Cervical Fusion Cage System
- K242567 — Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
- K242709 — JLK-PWI
- K243061 — SonoStik Guide Wire Introducer
- K240366 — EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter
- K240388 — Osteotomy Truss System (OTS)
- K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set
- K240881 — Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)
- K241068 — uDR 780i
- K241646 — ORTIV (ORTIV-BL, ORTIV-WH)
- K241828 — Affera Integrated Mapping System; Impedance Localization Patch Kit
- K241999 — Prophecy Surgical Planning System
- K242076 — VersaCross RF Wire
- K242269 — SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
- K242311 — EXPERT - Flexible Joint Fixation System
- K242320 — BD Vacutainer® One Use Holder
- K242393 — Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses
- K242452 — Monkey Bars Pin to Bar External Fixation System
- K242591 — XERO-alpha
- K242620 — Breo Laser Hair Growth Comb (Scalp 3L)
- K242665 — DePuy ATTUNE Total Knee System
- K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
- K243091 — Over-tube (TR-1108A)
- K243217 — Legend X Desktop System
- K243381 — Total Wrist Arthroplasty System (TWA)
- K240375 — V80 Anesthetic Vaporizer (V80)
- K240383 — Highness Implant System
- K240455 — BD Vacutainer® Citrate Blood Collection Tubes
- K240653 — SmartCardia 7L Platform (MCT)
- K241223 — eRAD PACS
- K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
Data sourced from openFDA. This site is unofficial and independent of the FDA.