510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
46,069 of the 176,466 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,669
176,466 records, page 2593 of 3530
510(k) clearances, page 2593 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K895671Stimtrac II Catalog Number 78-8500Stimtech ProductsIPFClass II
K895566Pemaco Economy Base Plate Wax-Medium SoftPemaco, Inc.EGDClass I
K895564Pemaco Bite Block Rods-Medium Soft & Medium HardPemaco, Inc.EGDClass I
K895563Pemaco Bite Wax SheetsPemaco, Inc.EGDClass I
K895562Pemaco 2000 Intraoral Dental WaxPemaco, Inc.EGDClass I
K895561Pemaco 3000 Intraoral Dental WaxPemaco, Inc.EGDClass I
K895500Patient Positioning AccessoriesPerkins Mfg. Co.IYEClass II
K895466Avl Model 912 Co-OxyliteAvl Scientific Corp.GLYClass II
K895295Ultima Xs Microcurrent TENSAmerican ImexGZJClass II
K895268Arrow Hands-Off Thermo-PaceArrow Intl., Inc.DQOClass II
K895045Model 410T Telecommunication SystemGE Medical Systems Information Technologies, Inc.HGMClass II
K895026Hp Model M1318a Transvaginal Ultrasound TransducerHewlett-Packard Co.HGLClass II
K894514Antimicrobial Susceptibility Test PanelAlamar Biosciences Laboratory, Inc.JWYClass II
K894142Ultranet-S CollimatorGE HealthcareIZWClass II
K894036Toitu Fetal Actocardiograph, Mt-332Toitu of America, Inc.HGMClass II
K893851TherastimPhysiodynamics, Inc.IPFClass II
K893821Acetabular Shells & Liners for Ath Total Hip Syst.Kinamed IncJDIClass II
K893744Smt-50A Magnetic Resonance Imaging SystemShimadzu Medical SystemsLNHClass II
K892941Cco System Model Sp1467,sp5567,sp6267Spectramed, LLCKRBClass II
K890044Biopro Anatomic Unicompartmental KneeBiopro, Inc.HRYClass II
K884651Electro Neuromuscular Stimulator Model 2000BioMedical Life Systems Inc.IPFClass II
K896172Strapped Eye ShieldEye Garter Company, Inc.HOYClass I
K896171Eye PatchEye Garter Company, Inc.HOYClass I
K896087Palestrant Irrigation and Drainage SetNorth American Instrument Corp.KGZClass I
K895834Baby Mac Electrocardiograph ElectrodeMarquette Electronics, Inc.DRXClass II
K895702Kdr Acetabular ComponentOsteonics Corp.LWJClass II
K895669Powder-Free/hypo-Allergenic Sterile Surgeon GlovesSafeskin Corp.KGOClass I
K895432Safe-T-CapAusmedics Pty, Ltd.FMIClass II
K895372X-Ray Detectable Gauze SpongeKeilei Intl., Inc.GDYClass I
K895226Neer II Total Shoulder System & Prosthesis3M CompanyKWSClass II
K895100Echo Gel (Rainforest)Lead-Lok, Inc.ITXClass II
K895077Surgical Mask/dental MaskAshton Medical Products, Inc.FXXClass II
K895076Cms Vrb-1200Cobe Laboratories, Inc.DTNClass II
K894958Model 410 Alert and Telecommunication SystemGE Medical Systems Information Technologies, Inc.HGMClass II
K894352Patient Examination GlovesRego Latex Progressive Corp.LYYClass I
K894176Full Ite, Low Profile, Helix, Canal Combin/sd CanaPrecision Hearing InstrumentsESDClass I
K894006Saniserv Surgical Slush SystemSaniserv, Inc.JRMClass I
K893928Levtech Small Bone PlateBuckman Co., Inc.KTWClass II
K893770Term Guard II DeviceTokos Medical Corp.HFMClass II
K892561Patient Examination Gloves (Latex)Maxicare Mfg. Corp.LYYClass I
K892167Patient Examination Gloves (Latex)Raewiks, Inc.LYYClass I
K891256Patient Examination Gloves (Latex)Raewiks, Inc.LYYClass I
K890902Biofix* Biodegradable Fixation RodDavis & Geck, Inc.HTYClass II
K890665Modified Cannula, Trocar and Obturator AccessoriesDyonics, Inc.HRXClass II
K896084MicrospearsSparta Surgical Corp.HOZClass II
K896004Alcon Surgical SpongeAlcon LaboratoriesHOZClass II
K895819Modified Labeling to the Spand-Gel Granulated GelMedi-Tech, Inc.KMFClass I
K895609Pupil Pathway Analyzer (Ppa)Pulse Medical InstrumentsHLGClass I
K895342Collagen Implants for the Lacrimal Efficiency TestLacrimedics, Inc.LZUUnclassified
K895253Pneumocheck W/printer/charger and AccessoriesWelch Allyn IncBZGClass II