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
154033–154056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1984
ADULT INCONTINENCE BRIEF
K834296 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 58d
Cleared Feb 04, 1984
THROMBOLYTIC ACTIVITY TEST
K834301 · GJA
Bio/Data Corp.
Hematology · 57d
Cleared Feb 04, 1984
CCS MODEL AV-102 IMPLANTABLE A-V DATA
K834342 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 54d
Cleared Feb 04, 1984
BHCG-CHECK
K834346 · JHJ
Diagnostic Technology, Inc.
Immunology · 54d
Cleared Feb 04, 1984
CARDIOTOMY RESERVORS BCR-3000/3500-Q-120
K834373 · DTN
American Bentley
Cardiovascular · 54d
Cleared Feb 04, 1984
GASTROINTESTINAL SHEATH BRUSH
K834402 · FDX
Hobbs Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Feb 04, 1984
INJECTION NEEDLE
K834403 · FBK
Bobbs Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Feb 04, 1984
ERCP CANNULA
K834414 · ODD
Hobbs Medical, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 04, 1984
TEMPERATURE SENSING FOLEY CATHETER
K834438 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 47d
Cleared Feb 04, 1984
INJECTION AIDE UNIT FOR DIAGETICS
K834440 · KZH
Gottinger Co.
General Hospital · 47d
Cleared Feb 04, 1984
COAXIAL BALLOON GASTROESOPHAGEAL DILA
K834451 · KNQ
Thomas J. Fogarty, M.D.
Gastroenterology & Urology · 47d
Cleared Feb 04, 1984
DIAGNOSTIC RADIOLOGY CATHETERS
K834459 · DQO
American Edwards Laboratories
Cardiovascular · 47d
Cleared Feb 04, 1984
NEPHROSTOMY/BILIARY DRAINAGE BAG
K834476 · LJE
Vertex Medical Corp.
Gastroenterology & Urology · 46d
Cleared Feb 04, 1984
INJECTION CAP
K834480 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 46d
Cleared Feb 04, 1984
ESKA JONAS SILICON-SILVER PENILE
K834504 · FAE
Dacomed Corp.
Gastroenterology & Urology · 45d
Cleared Feb 04, 1984
RENAFLO AVF SET FOR HEMODIALYSIS
K834510 · KNZ
Renal Systems, Inc.
Gastroenterology & Urology · 45d
Cleared Feb 04, 1984
PRESERV SAF FIXATIVE 15ML
K834566 · LIO
Preventive Diagnostics Corp.
Microbiology · 38d
Cleared Feb 04, 1984
FIBRINOGEN TEST
K834571 · KQJ
Diatech, Inc.
Hematology · 37d
Cleared Feb 04, 1984
BARD KARAYA GUM WASHERS
K834575 · EXB
C.R. Bard, Inc.
Gastroenterology & Urology · 37d
Cleared Feb 04, 1984
BIOSPAL 2400S
K834579 · KDT
Hospal Medical Corp.
Pathology · 37d
Cleared Feb 04, 1984
BIOSPAL (R) 1800S
K834589 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 37d
Cleared Feb 04, 1984
STOPEX-CONDOMS-
K834591 · HIS
Tropex Worldwide, Inc.
Obstetrics & Gynecology · 37d
Cleared Feb 04, 1984
BLOOD TUBING
K834596 · KOC
Renal Systems, Inc.
Gastroenterology & Urology · 36d
Cleared Feb 04, 1984
AUTOTECHNICON V TISSUE PROCESS SYS
K834599 · IEO
Technicon Instruments Corp.
Pathology · 36d