FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92257–92280 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1997
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K972986 · MJX
Boston Biomedica, Inc.
Microbiology · 58d
Cleared Oct 08, 1997
DRTS IMAGE INTENSIFIER DRAPE
K973073 · JAA
Minrad, Inc.
Radiology · 51d
Cleared Oct 08, 1997
MAMMOLOADER BY C.M.A. SRL
K973125 · IXW
C.M.A.
Radiology · 49d
Cleared Oct 08, 1997
AMBER DU
K973219 · KPR
Oldelft Corp. of America
Radiology · 42d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
K973327 · JAK
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
K973329 · JAK
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 08, 1997
DAR-3000B
K973342 · IZI
Shimadzu Corp.
Radiology · 33d
Cleared Oct 08, 1997
LIQUID LDH-L REAGENT SET
K973589 · CFJ
Pointe Scientific, Inc.,
Chemistry · 16d
Cleared Oct 07, 1997
TACTYLON CONDOM
K971590 · MOL
Sensicon Corp.
Obstetrics & Gynecology · 159d
Cleared Oct 07, 1997
RUSCH BRILLANT BALLOON CATHETER
K971643 · EZL
Rusch Intl.
Gastroenterology & Urology · 155d
Cleared Oct 07, 1997
BIPOLAR SCISSORS
K972558 · GEI
Enable Medical Corp.
General & Plastic Surgery · 90d
Cleared Oct 07, 1997
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION...
K972678 · FRN
Mcgaw, Inc.
General Hospital · 83d
Cleared Oct 07, 1997
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN...
K972825 · FGE
Cordis Corp.
Gastroenterology & Urology · 90d
Cleared Oct 07, 1997
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)
K972847 · LMC
Eastman Kodak Company
Radiology · 67d
Cleared Oct 07, 1997
PLA-96P
K973086 · EJJ
Southern Dental Industries, Inc.
Dental · 50d
Cleared Oct 07, 1997
TOKUSO REBASE MR. BOND
K973245 · KLE
Tokuyama America, Inc.
Dental · 39d
Cleared Oct 07, 1997
PRECINORM RF, PRECIPATH RF
K973629 · JJY
Boehringer Mannheim Corp.
Immunology · 13d
Cleared Oct 06, 1997
REAADS PROTEIN C ANTIGEN TEST KIT
K972342 · GGP
Reaads Medical Products, Inc.
Hematology · 104d
Cleared Oct 06, 1997
NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY
K972561 · GEX
American Laser Medical
General & Plastic Surgery · 89d
Cleared Oct 06, 1997
HOWMEDICA FULLY THREADED SCREWS
K972811 · HSB
Howmedica Corp.
Orthopedic · 70d
Cleared Oct 06, 1997
ACCUWELL T4-EIA
K972974 · KLI
Neometrics, Inc.
Chemistry · 56d
Cleared Oct 06, 1997
2487 DUAL WAVELENGTH ABSORBANCE DETECTOR
K973074 · KZR
Waters Corporation
Toxicology · 49d
Cleared Oct 06, 1997
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN,...
K973126 · JHX
Biosite Incorporated
Chemistry · 47d
Cleared Oct 06, 1997
MYOGLOBIN CONTROL SET
K973358 · JJX
Boehringer Mannheim Corp.
Chemistry · 28d