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
152833–152856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1984
CATEGORY 17-MICROBIOLOGY DEVICES
K840304 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 98d
Cleared May 01, 1984
BOSWORTH DENT-ALL
K840405 · EBI
Harry J. Bosworth Co.
Dental · 91d
Cleared May 01, 1984
RX ELAN
K840561 · EJS
Jeneric Ind.
Dental · 83d
Cleared May 01, 1984
RX C & B 20
K840563 · EJS
Jeneric Ind.
Dental · 83d
Cleared May 01, 1984
DIA THROMBIN DIA PLASTIN
K840802 · GJS
Diatech, Inc.
Hematology · 68d
Cleared May 01, 1984
BIOSURE
K840848 · JJW
Helena Laboratories
Hematology · 67d
Cleared May 01, 1984
URINARY MONITORING SYS 240
K840917 · KNX
Vital Metrics, Inc.
Gastroenterology & Urology · 61d
Cleared May 01, 1984
URINE ANALYZER SYSTEM
K840996 · KQO
Kyoto Diagnostics, Inc.
Chemistry · 54d
Cleared May 01, 1984
SURGICAL RETRACTORS-VARIOUS
K841009 · GAD
Premier Dental Products Co.
General & Plastic Surgery · 53d
Cleared May 01, 1984
SURGICAL HOOKS, VARIOUS
K841010 · GDG
Premier Dental Products Co.
General & Plastic Surgery · 53d
Cleared May 01, 1984
WEIGHTED FEEDING TUBE W/PRE-INSERTED
K841014 · KNT
Ethox Corp.
Gastroenterology & Urology · 53d
Cleared May 01, 1984
COATED TUBE HCG IMMUNOASSAY HCG
K841023 · JHI
Ventrex Laboratories, Inc.
Chemistry · 50d
Cleared May 01, 1984
URIC ACID REAGENT SET ENZYMATIC
K841049 · KNK
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
TOTAL BILIRUBIN REAGENT SET
K841050 · CIG
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
SERUM CALCIUM REAGENT SET
K841051 · CIC
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
CHOLESTEROL REAGENT SET
K841052 · CHD
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
CHOLESTEROL REAGENT SET ENZYMATIC
K841053 · CHH
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
DIRECT GLUCOSE REAGENT SET
K841054 · CGE
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
GLUCOSE ENZYMATIC REAGENT SET
K841055 · CGA
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
HDL PRECIPITANT REAGENT SET
K841056 · JHM
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
LDH-UV REAGENT SET
K841058 · CFJ
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
SGPT REAGENT SET
K841059 · CKD
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
SGPT REAGENT SET
K841060 · CKA
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
PHOPHORUS REAGNET SET
K841061 · CEO
Medical Specialties, Inc.
Chemistry · 50d