FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
129817–129840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1989
PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT
K893725 · HEB
Playtex Family Products, Inc.
Obstetrics & Gynecology · 79d
Cleared Aug 04, 1989
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
K893927 · ESD
Resound Corp.
Ear, Nose, Throat · 65d
Cleared Aug 04, 1989
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031 · HIO
Baxter Healthcare Corp
Obstetrics & Gynecology · 59d
Cleared Aug 04, 1989
SURGICAL DYNAMICS DISCOGRAPHY SYSTEM
K894336
Surgical Dynamics, Inc.
General & Plastic Surgery · 21d
Cleared Aug 04, 1989
QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
K894538 · DBN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 15d
Cleared Aug 03, 1989
BURRON TEFLON-COATED GUIDEWIRE
K884183 · DQX
Burron Medical, Inc.
Cardiovascular · 303d
Cleared Aug 03, 1989
JAMES SURGICAL SYSTEM J1000
K890195 · HQE
O.R. Specialties, Inc.
Ophthalmic · 197d
Cleared Aug 03, 1989
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)
K890402 · FAE
Mentor Corp.
Gastroenterology & Urology · 191d
Cleared Aug 03, 1989
AMBULATORY INFUSION PUMP
K890862 · FRN
Medfusion, Inc.
General Hospital · 163d
Cleared Aug 03, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891184 · LYY
Healthcare Gloves Sdn Bhd
General Hospital · 150d
Cleared Aug 03, 1989
QBC MALARIA SYSTEM
K891276 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 147d
Cleared Aug 03, 1989
GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG
K891371 · KNT
Entech, Inc.
Gastroenterology & Urology · 147d
Cleared Aug 03, 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
K891580 · DQO
Boston Scientific Corp
Cardiovascular · 136d
Cleared Aug 03, 1989
HYDRO-SAN COLONIC IRRIGATION SYSTEM
K891585 · KPL
Specialty Health Products, Inc.
Gastroenterology & Urology · 136d
Cleared Aug 03, 1989
RUBELLA ELISA TEST SYSTEM
K891783 · LFX
Zeus Scientific, Inc.
Microbiology · 132d
Cleared Aug 03, 1989
BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
K892338 · ESD
Qualitone
Ear, Nose, Throat · 120d
Cleared Aug 03, 1989
IFA SENSIBAC NEOMYCIN
K892714 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC NITROFURANTOIN
K892715 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC BACITRACIN
K892717 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC TETRACYCLINE
K892718 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC ERYTHROMYCIN
K892719 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC CINOXACIN
K892722 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC POLYMYXIN B
K892723 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC STREPTOMYCIN
K892724 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d