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
166969–166992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1980
STAT TEMP MODEL 4800
K800396 · FLL
Baessler Medical Electronics,Inc.
General Hospital · 28d
Cleared Mar 25, 1980
FERRIS MODIFIED DISP. IL STERNAL-ILIAC
K800413 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 28d
Cleared Mar 25, 1980
ADT MENGHINI TYPE SOFT TISSUE BIOPSY
K800415 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 28d
Cleared Mar 25, 1980
ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)
K800416 · FCG
A.D.T. Lab Industries
Gastroenterology & Urology · 28d
Cleared Mar 25, 1980
ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL
K800419 · FCG
A.D.T. Lab Industries
Gastroenterology & Urology · 28d
Cleared Mar 25, 1980
ADT PERCUTANEOUS NON-DISP. NEEDLE
K800420 · FCG
A.D.T. Lab Industries
Gastroenterology & Urology · 28d
Cleared Mar 25, 1980
ADT PERITONEAL LAVAGE TRAY (DISP.)
K800421 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 28d
Cleared Mar 25, 1980
ADT NERVE BLOCK TRAY(DISP.)
K800423 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 28d
Cleared Mar 25, 1980
HELENA RISTOCETIN
K800432 · JOZ
Helena Laboratories
Hematology · 27d
Cleared Mar 25, 1980
ORTHODONTICARTIDE
K800458 · EBI
European Orthodontic Products
Dental · 25d
Cleared Mar 25, 1980
LASER BACKPOINTER ASSEMBLY, MOD. 01-2487
K800489 · IWE
Atc Medical Technology, Inc.
Radiology · 21d
Cleared Mar 25, 1980
ADULT ANESTHESIA BREATHING CIRCUITS . .
K800498 · CAI
Airlife, Inc.
Anesthesiology · 21d
Cleared Mar 25, 1980
PEDIATRIC ANESTHESIA BREATHING CIRCUITS
K800499 · CAI
Airlife, Inc.
Anesthesiology · 21d
Cleared Mar 25, 1980
OXYGEN CATHETER
K800506 · BZB
Medi-Craft , Ltd.
Anesthesiology · 21d
Cleared Mar 25, 1980
CONNECTING TUBES
K800509 · BYX
Medi-Craft , Ltd.
Anesthesiology · 21d
Cleared Mar 25, 1980
ELECTRONIC CLINICAL THERM. MODEL 811A
K800512 · FLL
Y
General Hospital · 20d
Cleared Mar 25, 1980
MICRO ELISA AUTO READER
K800522 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 19d
Cleared Mar 25, 1980
MODEL 52 BUNN DRY AIR SUPPLY
K800534 · BTI
Greene & Kellogg, Inc.
Anesthesiology · 18d
Cleared Mar 25, 1980
BUNN VOLUMAIRE RESPIRATORY EXERCISER
K800546 · BWF
The John Bunn Co.
Anesthesiology · 15d
Cleared Mar 25, 1980
MEDISTOR III LUNG ANALYZER
K800547 · BZC
Cybermedic, Inc.
Anesthesiology · 15d
Cleared Mar 25, 1980
TRIGLYCERIDES TEST (500NM)
K800551 · JGY
Reagents Applications, Inc.
Chemistry · 15d
Cleared Mar 25, 1980
DIFFERENTIAL REFRACTIVE INDEX DETECTOR
K800556 · KIE
Hewlett-Packard Co.
Toxicology · 13d
Cleared Mar 25, 1980
LIPID CONTROL PRODUCT # ACS LC 101
K800558 · JJY
Analytical Control Systems, Inc.
Chemistry · 13d
Cleared Mar 25, 1980
SERTROL PRODUCT # ACS ST 101
K800559 · JJY
Analytical Control Systems, Inc.
Chemistry · 13d