FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
130417–130440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 03, 1989
IFA SENSIBAC VANCOMYCIN
K892725 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC INIPENEM
K892727 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC TOBRAMYCIN
K892729 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC CHLROAMPHENICOL
K892730 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
MG II POROUS TOTAL KNEE SYSTEM
K892800 · JWH
Zimmer, Inc.
Orthopedic · 108d
Cleared Aug 03, 1989
PRECIOUS LITE MODEL 4224
K892940 · LBI
E & B Technologies, Inc.
General Hospital · 104d
Cleared Aug 03, 1989
LATEX EXAM GLOVES
K892971 · LYY
P.C. Commercial, Inc.
General Hospital · 113d
Cleared Aug 03, 1989
PATIENT EXAMINATION GLOVES
K892981 · LYY
Lapoma Gloves Industries Sdn. Bhd.
General Hospital · 113d
Cleared Aug 03, 1989
PATIENT LATEX EXAMINATION GLOVES
K892982 · LYY
Ataro Industri (Malaysia) Sdn Bhd
General Hospital · 113d
Cleared Aug 03, 1989
APACERAM OSSICULAR PROSTHESIS
K893134 · ETB
Asahi Optical Co. C/O Rosati...
Ear, Nose, Throat · 100d