FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93841–93864 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1997
LIFECORE O-RING ABUTMENT
K970776 · DZE
Lifecore Biomedical, Inc.
Dental · 84d
Cleared May 27, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7)
K970786 · MRZ
Alexander Mfg. Co.
General Hospital · 84d
Cleared May 27, 1997
NON-STERILE ISOLATION GOWN
K970814 · FYC
American Seal Co.
General Hospital · 82d
Cleared May 27, 1997
COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY,...
K971202 · OCZ
Comeg Endoskopie GmbH
Gastroenterology & Urology · 56d
Cleared May 27, 1997
LSVP INTERNATIONAL HOT BIOPSY FORCEPS
K971204 · KGE
Lsvp Intl., Inc.
Gastroenterology & Urology · 56d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018
K971212 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P
K971213 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825
K971234 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108
K971237 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
IMMULITE PYRILINKS-D
K971312 · JMM
Diagnostic Products Corp.
Chemistry · 48d
Cleared May 27, 1997
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
K971477 · CDQ
Trace America, Inc.
Chemistry · 34d
Cleared May 27, 1997
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K971485 · CDO
Trace America, Inc.
Chemistry · 34d
Cleared May 27, 1997
QUANTEX ASO-CRP-RF CONTROL
K971777 · JJT
Instrumentation Laboratory CO
Chemistry · 13d
Cleared May 23, 1997
RUSCH ENTERAL FEEDING TUBE
K963779 · FPD
Rusch, Inc.
Gastroenterology & Urology · 245d
Cleared May 23, 1997
CENTOCOR CA 15-3 RIA MODEL NO. 800-033
K963803 · MOI
Centocor, Inc.
Immunology · 242d
Cleared May 23, 1997
OCCLUSION CLAMP** DEVICE
K964251 · DXC
United States Surgical, A Division of...
Cardiovascular · 211d
Cleared May 23, 1997
BETTER-BLADDER (BB)
K964337 · FIB
Circulatory Technology, Inc.
Gastroenterology & Urology · 204d
Cleared May 23, 1997
STA D-DI CALIBRATOR KIT
K964718 · DAP
American Bioproducts Co.
Hematology · 179d
Cleared May 23, 1997
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
K970077 · KPI
Utah Medical Products, Inc.
Gastroenterology & Urology · 134d
Cleared May 23, 1997
#ES-32 SUCTION CATHETER 32 FR.
K970890 · KNT
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 73d
Cleared May 23, 1997
AUTO HDL CHOLESTEROL CALIBRATOR
K970933 · JIS
Pointe Scientific, Inc.,
Chemistry · 71d
Cleared May 23, 1997
ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR
K971100 · EIA
Atrion Medical Products, Inc.
Dental · 58d
Cleared May 23, 1997
ENDO SMARTCAP (100501)
K971125 · OCX
Endo Smart Cap Co.
Gastroenterology & Urology · 57d
Cleared May 23, 1997
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
K971275 · FDI
Mill-Rose Laboratory
Gastroenterology & Urology · 46d