FDA 510(k) clearances — page 50
clearances on record, most recent first.
Clearances — page 50
4,901–5,000 of 175,620- 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; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL
- 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 (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);
- K243573 — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
- 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
- K243452 — Orthoscan VERSA Mini C-Arm
- K243577 — Radical the Dude 8F Guide Catheter
- K243904 — Elegance® Anterior Cervical plate
- K233452 — Vivo 45 LS
- K241059 — Pantheon Proximal Femur Reconstruction (PFR) System
- K241200 — SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
- K241431 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)
- K242030 — MegaGen Dental Implant Abutment
- K242680 — LetsGetChecked Impress
- K242689 — AAMI Level 4 Protective; Gown
- K243262 — QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test
- K243271 — MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer
- K243295 — Initia Knee System
- K243527 — High Flow Insufflation Unit (UHI-4)
- K243533 — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
- K243791 — Air Pressure Therapy System
- K243890 — Arthrex Intramedullary Nails
- K243909 — Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric
- K243950 — ARVIS® Shoulder
- K243836 — Mentor CPX 4 PLUS Enhance Breast Tissue Expander
- K241641 — Electric Wheelchair (YE200)
- K240267 — Klaxon (Twist); Klaxon (Twist R)
- K241009 — PeriCALM Patterns 3.0
- K241064 — Unscented Tampon
- K241174 — INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
- K241676 — TriVerity
- K241764 — Mould Probe MR Safe
- K241781 — Solo Pace Control
- K241891 — ScreenDx
- K242071 — Xpert Xpress CoV-2/Flu/RSV plus
- K242228 — Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)
- K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
- K242528 — Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
- K242767 — Safecare Urinary Tract Infection Test
- K242877 — BioCode Gastrointestinal Pathogen Panel (GPP)
- K242901 — ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
- K243111 — Bowhead ERA Wheelchairs
- K243195 — Arthrex SS VAL and VAL KreuLock Compression Screw System
- K243477 — Universal Tendon Spacer
- K243492 — Ulike Reglow Light Therapy Device (UM10)
- K243806 — Safety Winged Blood Collection Sets
- K243811 — Erchonia Zerona® VZ8
- K243814 — NuVasive Pulse System
- K241273 — FullFocus
- K242805 — Dental Cone-beam Computed Tomography (FinScan F350)
- K240590 — Electrical Scooter, WT-T4SU
- K241003 — HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
- K241489 — ReminGel
- K241806 — Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel
- K242043 — Sperm Freezing Medium
- K242290 — DormoTech NLab
- K242661 — TRI-matrix® X-Force Implants
- K242741 — ACE Cannula
- K242842 — ANNE View, Central Hub
- K243644 — Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
- K243813 — QIAstat-Dx GI Panel 2 Mini B&V
- K243818 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- K241079 — uCT 780
- K241456 — GlutenID Celiac Genetic Health Risk Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.