FDA 510(k) clearances — page 41
clearances on record, most recent first.
Clearances — page 41
4,001–4,100 of 175,620- K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
- K251056 — Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode
- K251071 — Fetal EchoScan (v1.1)
- K242315 — Resolve Modular Revision Hip Stem
- K243521 — Conical Ti Base abutments
- K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution
- K244020 — Wrinkle Treatment Device (JM1, JM2B)
- K250029 — ONE TRAY® Sealed Sterilization Container System
- K250087 — Vscan Air
- K250296 — Disposable Distal Attachment D-201 Series
- K250641 — APEX 3D Total Ankle Replacement System
- K250995 — Xpert Xpress CoV-2/Flu/RSV plus
- K250996 — Xpert Xpress CoV-2/Flu/RSV plus
- K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
- K251014 — APRO 45 Catheter
- K243541 — LumiRex Bronchoscope
- K243934 — Stable-L Lumbar Interbody System
- K243942 — Arctic Sun Stat Temperature Management System
- K244000 — Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);
- K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
- K250282 — Persona C HR
- K250295 — Dentsply Sirona Titanium Bases system
- K250328 — UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
- K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin
- K250683 — Resolve Fundus Camera
- K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
- K251015 — APRO 45 Catheter and Alembic Aspiration Tubing
- K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
- K251051 — AuST Steerable Sheath
- K242211 — PUMA-G Pediatric System
- K242255 — Qitexio® 4-Way Stopcock (QIT014)
- K242354 — AllNEB
- K242495 — LMA Fastrach ETT SU
- K243886 — ExpressCore Biopsy Device
- K243963 — Pediatric Plating Platform Hip
- K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- K250308 — Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
- K250617 — Apex Flex
- K250962 — APRO 55 Intermediate Catheter
- K241663 — Eminent Spine 3D Titanium Pedicle Screw System
- K242951 — Diode laser hair removal machine (QDTM-02)
- K243376 — uAngio AVIVA CX
- K243532 — LumiRex Ureteroscope
- K243896 — LenSx Laser System (8065998162)
- K250030 — Flash Ultrasound System 5100 Point of Care
- K250158 — Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)
- K250256 — Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
- K250958 — APRO 55 Swift Catheter and Alembic Aspiration Tubing
- K250977 — Suture-TOOL System
- K251101 — AIRO Suction Unit (AIRO-01)
- K242321 — Kosmos
- K242469 — RFMagik Lite
- K243041 — contact forte Alpha
- K243082 — Infrared Thermometer
- K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
- K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
- K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
- K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
- K243721 — Self Sealing Sterilization Pouches
- K243821 — i-Cut
- K243855 — BD Alaris Infusion System with Guardrails Suite MX
- K243861 — butterflyBVM
- K243876 — VERIFY STEAM Integrating Indicator
- K243998 — DCX Disposable Cassette (DCX)
- K244026 — PAL 7020 Console
- K250046 — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
- K250153 — Neu Platform
- K250289 — Intracavitary/Interstitial System
- K250426 — Amulet Steerable Delivery Sheath
- K250554 — prodisc® L Instruments
- K250608 — Mako Total Knee Application (3.0); Hybrid Tip Pointer
- K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
- K250892 — CastleLoc Pectus Bar System
- K250909 — Prelude Wave Hydrophilic Sheath Introducer
- K251075 — DYNAMIS Implant System
- K251117 — Cervical Spine Truss System (CSTS)
- K233337 — Freespira Breathing System
- K242214 — Sonu
- K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
- K242963 — MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs
- K242973 — CanMINI Hand and Foot System
- K243239 — Lung AI (LAI001)
- K243714 — da Vinci SP Surgical System (SP1098)
- K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
- K243954 — PeriCross Epicardial Access Kit
- K250002 — Smart Check O2 (MA0236)
- K250116 — Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)
- K250183 — CO2 Laser System (CO2 Laser SST-L23)
- K250206 — Diode laser system (Night Universe; Predator)
- K250262 — GO-PEN®
- K242232 — Mpact 3D Metal Augments II
- K242531 — NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz
- K243326 — Dynamis Robotic Surgical System
- K243479 — EchoGuide (Version 1)
- K243697 — MySpine WebPlanner
- K250155 — Xpert Knee
- K250198 — Laon Ortho
- K250228 — eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)
- K250697 — Electric Nasal Aspirator (BC026, BC025, BC023)
- K250831 — Annalise Enterprise
Data sourced from openFDA. This site is unofficial and independent of the FDA.