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
138337–138360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1987
OXIMETRY MODULE
K872626 · DQA
Marquette Electronics, Inc.
Anesthesiology · 71d
Cleared Sep 15, 1987
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741
K872629 · DXN
A&D Engineering, Inc.
Cardiovascular · 71d
Cleared Sep 15, 1987
SHEATH/DILATORS
K872724 · DRE
Med-West, Inc.
Cardiovascular · 69d
Cleared Sep 15, 1987
PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860
K872731 · DTB
Ela Medical, Inc.
Cardiovascular · 69d
Cleared Sep 15, 1987
PERFUSION CATHETER
K872790 · DQT
Bd Becton Dickinson Vacutainer...
Cardiovascular · 63d
Cleared Sep 15, 1987
POLYURETHANE CATHETER FOR THE INFUSE-A-PORT
K872898 · LJT
Shiley Infusaid, Inc.
General Hospital · 54d
Cleared Sep 15, 1987
MEGABED 1000
K872925 · FNL
Surgi-Med, Inc.
General Hospital · 50d
Cleared Sep 15, 1987
MOSS(R) MARK IV NASAL TUBES CAT.# 87168
K872932 · KNT
Mfg. and Research, Inc.
Gastroenterology & Urology · 50d
Cleared Sep 15, 1987
GUIDING CATHETER
K873004 · DQO
Mallinckrodt Critical Care
Cardiovascular · 42d
Cleared Sep 15, 1987
MODIFIED VISIO-SEAL
K873069 · EBC
Espe GmbH (Us)
Dental · 40d
Cleared Sep 15, 1987
HEARING AID (IN-THE-EAR)
K873070 · ESD
Central Illinois Hearing Aid Centers,...
Ear, Nose, Throat · 41d
Cleared Sep 15, 1987
BUNN CONCENTRATOR MODEL 2100 SERIES
K873071 · CAW
The John Bunn Co.
Anesthesiology · 41d
Cleared Sep 14, 1987
DIAGNOSTIC KIT FREE T3 AND FREE T4
K870268 · CEC
Sclavo, Inc.
Chemistry · 234d
Cleared Sep 14, 1987
SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
K870923 · KWA
Protek, Inc.
Orthopedic · 194d
Cleared Sep 14, 1987
CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.
K870924 · KWA
Protek, Inc.
Orthopedic · 194d
Cleared Sep 14, 1987
AIS ANGIOSCOPE
K871492 · DQX
Advanced Interventional Systems, Inc.
Cardiovascular · 151d
Cleared Sep 14, 1987
FLEXIBLE URETEROSCOPE
K872282 · FGB
Intramed Laboratories, Inc.
Gastroenterology & Urology · 90d
Cleared Sep 14, 1987
WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR
K872378 · DTN
C.R. Bard, Inc.
Cardiovascular · 87d
Cleared Sep 14, 1987
ACA URINE DRUGS OF ABUSE CALIBRATOR
K872392 · DKB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 87d
Cleared Sep 14, 1987
SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE
K872472 · DXT
Angiomedics, Inc.
Cardiovascular · 83d
Cleared Sep 14, 1987
SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER
K872542 · LIT
Angiomedics, Inc.
Cardiovascular · 77d
Cleared Sep 14, 1987
ROTASCREEN
K872568 · GOB
Mercia Diagnostics , Ltd.
Microbiology · 77d
Cleared Sep 14, 1987
VIRON(TM)
K872646 · JJT
bioMerieux, Inc.
Chemistry · 70d
Cleared Sep 14, 1987
IAFP V. AGAR SELECTIVE
K872690 · JSJ
I.A.F. Production, Inc.
Microbiology · 69d