Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
140257–140280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1987
SIMPSON PERIPHERAL ATHEROCATH(TM)
K871011 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 62d
Cleared May 14, 1987
PRECIMAT(R) TRANSFERRIN
K871022 · DDG
Boehringer Mannheim Corp.
Immunology · 59d
Cleared May 14, 1987
PRECIMAT(R) C4
K871023 · DBI
Boehringer Mannheim Corp.
Immunology · 59d
Cleared May 14, 1987
X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R
K871116 · IYH
X-Cel X-Ray Corp.
Radiology · 56d
Cleared May 14, 1987
H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
K871351 · BZD
Holter-Hausner Intl.
Anesthesiology · 38d
Cleared May 14, 1987
SIEMENS MAIN FLOW BACTERIA FILTER
K871366 · CAH
Siemens Elema AB
General Hospital · 37d
Cleared May 14, 1987
VISION (TM) HDL CHOLESTEROL
K871461 · LBS
Abbott Laboratories
Chemistry · 30d
Cleared May 14, 1987
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583
K871530 · CIG
American Research Products Co.
Chemistry · 24d
Cleared May 14, 1987
SMILJANIC BONE REPOSITIONING FORCEPS
K871535 · HTD
Link America, Inc.
General & Plastic Surgery · 24d
Cleared May 14, 1987
HPROLACTIN KIT
K871542 · CFT
Immuchem Corp.
Chemistry · 24d
Cleared May 14, 1987
WESTERN RAGWEED ALLERGEN DISC
K871660 · DHB
Incstar Corp.
Immunology · 16d
Cleared May 13, 1987
HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)
K870128 · JDI
Richards Medical Co., Inc.
Orthopedic · 121d
Cleared May 13, 1987
THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
K871105 · LIC
New Horizons Diagnostics Co.
Microbiology · 55d
Cleared May 13, 1987
ABBOTT A-GENT LD-1 ISOZYME REAGENT
K871240 · JGF
Abbott Laboratories
Chemistry · 47d
Cleared May 13, 1987
TODD HEWITT W/CNA (LIM BROTH)
K871447 · JSD
Remel Co.
Microbiology · 30d
Cleared May 13, 1987
BUFFALO GREEN MONKEY KIDNEY CELLS
K871613 · KIR
Viromed Laboratories, Inc.
Pathology · 19d
Cleared May 13, 1987
ALKALINE PEPTONE WATER
K871640 · JSD
Bd Becton Dickinson Vacutainer...
Microbiology · 16d
Cleared May 12, 1987
DSP100 CAROTID PHONOANGIOGRAPHY MODULE
K864429 · DQC
Intl. Acoustics, Inc.
Cardiovascular · 181d
Cleared May 12, 1987
40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER
K864567 · DSP
Aries Medical, Inc.
Cardiovascular · 174d
Cleared May 12, 1987
40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER
K864568 · DSP
Aries Medical, Inc.
Cardiovascular · 174d
Cleared May 12, 1987
KODAK EKTACHEM DT SLIDES (CA)
K870035 · CID
Eastman Kodak Company
Chemistry · 127d
Cleared May 12, 1987
IONOMETER EF AND ACCESSORIES
K870183 · JGS
Smash Ent., Inc.
Chemistry · 116d
Cleared May 12, 1987
PCTE MICROPOROUS MEMBRANE FILTER
K870196 · KET
Poretics Corp.
Pathology · 112d
Cleared May 12, 1987
T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)
K870221 · KPQ
Kermath Mfg. Corp.
Radiology · 111d