FDA 510(k) clearances — page 58
clearances on record, most recent first.
Clearances — page 58
5,701–5,800 of 176,479- K241367 — RF Cannula
- K241728 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
- K241819 — CephNinja
- K242714 — Mobility Scooter (S-01); Mobility Scooter (S-02)
- K243158 — TeraRecon Aorta.CT (1.1.0)
- K243219 — MONARCH Platform (MON-000008)
- K243624 — Acu-Sinch Knotless Mini
- K243668 — ProLift Pivot Expandable Spacer System
- K240311 — JETT Medical II
- K241357 — XT3 System
- K241956 — Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
- K242446 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
- K242835 — Suture-TOOL System
- K243008 — Arthrex NanoScope System
- K243139 — Reverso Pro System
- K243350 — Rapid Neuro3D
- K243976 — ZeroClear Bag Access (423100)
- K243977 — EMPHASYS Acetabular System
- K243982 — Nicolet EDX
- K243985 — Rio Drug Reconstitution Transfer Device
- K241443 — Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011) +3 more
- K241444 — Biliary Pancreaticobiliary Scope System
- K242288 — Advanced Cryo Wart Remover
- K243303 — Ziehm Vision RFD 3D
- K243929 — Oligio X
- K243955 — Precision AI Surgical Planning System (PAI-SPS)
- K241910 — Neonav ECG Tip Location System
- DEN230051 — Myocene
- K240217 — cobas® liat CT/NG nucleic acid test
- K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
- K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
- K241269 — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
- K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)
- K241949 — Digital Color Doppler Ultrasound System (P60 Series)
- K242051 — VersaD Delivery Catheter
- K242064 — Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut)
- K242171 — TechCare Trauma
- K242336 — hygh-tec Drainage II
- K242374 — ULSPIRA TS Nitric Oxide Therapy System
- K242608 — Embozene Color-Advanced Microspheres
- K242705 — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
- K242765 — Electronic Apex Locator (Alpha Apex I)
- K242825 — Prenuvo Body Composition
- K242860 — Type 5 Integrating Indicator for Steam (CSPN-15)
- K243067 — The ETHICON Total Energy System
- K243218 — TBS iNsight (V4)
- K243249 — TriALTIS Spine System
- K243291 — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
- K243315 — ProGrip Self-Gripping Polypropylene Mesh
- K243502 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
- K243545 — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC +9 more
- K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
- K243605 — Aurora
- K243606 — Babyroo TN300
- K243706 — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules
- K243892 — Affera Integrated Mapping System
- K243935 — Aptima CMV Quant Assay
- K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201) +3 more
- K233770 — Pepper EMS Training System
- K240197 — cobas® liat CT/NG/MG nucleic acid test
- K241113 — VIVIX-M
- K241176 — Alere NT-proBNP for Alinity i Reagent Kit
- K241217 — CloudHRV System (100-01-001)
- K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection
- K242416 — Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12 +2 more
- K242522 — Second Opinion CC
- K242715 — Pearl Clear Aligner
- K242834 — System 9 Sterile Battery Container
- K243256 — WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest
- K243289 — ADDNOX (BPSPM1)
- K243848 — Cala kIQ
- K243885 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
- K244048 — Medi Lift Mask
- K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System
- K241512 — Electrode Pad
- K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
- K242229 — Micro Ace Gold Advanced Micro Access System
- K242541 — GEM ZIPCLIP
- K242634 — PuraStat
- K242667 — AeroChamber2go Anti-Static Valved Holding Chamber
- K242873 — Ventrax Delivery System
- K242935 — Respiration Data Management Software (PAP Link PC)
- K242936 — Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K243065 — Cardiac Guidance
- K243284 — RELiZORB (100300/ 100301)
- K243328 — Ziehm Vision RFD
- K243569 — TriMed Wrist Fixation System (10 models)
- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
- K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
- K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM)
- K243946 — EffortMed Spinal Fixation System
- K241037 — ABL90 FLEX PLUS System
- K241066 — BB-613-BPM
- K241166 — uCT 550
- K241180 — Consensus Knee System with TiNbN
- K241278 — ASEPT® Glide Peritoneal Drainage System
- K242205 — SpectoMed (v1.0)
- K242672 — Zoom System
- K243272 — LOCATOR Angled Abutment
- K243297 — APRO 70 Swift Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.