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
173065–173088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1977
INTRODUCER, CAT. #INT-05FR.
K771042 · DYB
Sorensen Research
Cardiovascular · 34d
Cleared Jul 12, 1977
TRIGLYCERIDE KIT
K771068 · JGM
Environmental Chemical Specialties
Chemistry · 29d
Cleared Jul 11, 1977
THROMBO SCREEN QUANTITATIVE HEPARIN ASSA
K770722 · JBR
Bay Area Hema. Onco. Clinic. & Res. L
Hematology · 83d
Cleared Jul 11, 1977
TABLE, TREATMENT, THERAPY, PHYSICAL
K770723 · INT
Chattanooga Pharmacal Co.
Physical Medicine · 83d
Cleared Jul 11, 1977
TRACTION DEVICES, INTERMITTENT, TX
K770724 · IRS
Chattanooga Pharmacal Co.
Physical Medicine · 83d
Cleared Jul 11, 1977
PUMP, INFUSION, DYNATECH/HANDLEY
K770730 · FRN
Dynatech Medical Products
General Hospital · 82d
Cleared Jul 11, 1977
PIPETTE, DISPENSING, MODEL ADP-30SD
K770772 · JQW
G.D. Searle and Co.
Chemistry · 74d
Cleared Jul 11, 1977
PIPETTE, DILUTING, MODEL ADP-30SD
K770773 · JQW
G.D. Searle and Co.
Chemistry · 74d
Cleared Jul 11, 1977
LYTETEK SYSTEM
K770774 · JGT
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared Jul 11, 1977
REAGENTS
K770780 · CHH
Chemetrics Corp.
Chemistry · 73d
Cleared Jul 11, 1977
SHAVE PREP SET
K770795 · JJX
Lukens Corp.
Chemistry · 70d
Cleared Jul 11, 1977
TRAY, CATHETERIZATION W/FOLEY, STERILE
K770797 · FRG
Lukens Corp.
General Hospital · 70d
Cleared Jul 11, 1977
ULTRAZYME PLUS GT
K770815
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM ALBUMIN
K770816 · CIX
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM CALCIUM
K770817 · CJY
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRAZYME PLUS, LDH
K770818 · CFJ
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM CREATININE
K770819 · CGX
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM INORGANIC PHOSPHORUS
K770820 · CEO
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
A-GENT ALBUMIN
K770822 · CIX
Abbott Laboratories
Chemistry · 68d
Cleared Jul 11, 1977
SPECTROPHOTOMETERS,34,35,36,3600
K770825
Beckman Instruments, Inc.
Chemistry · 67d
Cleared Jul 11, 1977
PLATELET AGITATOR
K770830 · GLE
Helmer Labs, Inc.
Hematology · 66d
Cleared Jul 11, 1977
STATZYME URIC ACID REAGENT
K770831 · CDO
Worthington Biochemical Corp.
Chemistry · 66d
Cleared Jul 11, 1977
CIRCUMCISION KIT
K770873 · FHG
American Hospital Supply Corp.
Obstetrics & Gynecology · 59d
Cleared Jul 11, 1977
BURN DRESSING KIT
K770889 · EFQ
The Owenby Co.
General & Plastic Surgery · 56d