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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
155425–155448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 1983
ULTRAVIT
K834163 · HQE
American Surgical Co., Inc.
Ophthalmic · 75d
Cleared Dec 27, 1983
SUCTION-HEMORRHOID-LIGATOR
K832192 · FHN
Research Endoscope Systems Intl.
Gastroenterology & Urology · 172d
Cleared Dec 27, 1983
VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY
K832285 · FRN
Travenol Laboratories, S.A.
General Hospital · 167d
Cleared Dec 27, 1983
VOLUME VENTILATOR
K832508 · CBK
Sechrist Industries, Inc.
Anesthesiology · 153d
Cleared Dec 27, 1983
MALE THERAPEUTIC POTENT AID
K832543 · LKY
Mace'S Scientific
Gastroenterology & Urology · 151d
Cleared Dec 27, 1983
OPEN END SPRING GUIDE
K832607 · DQX
C.R. Bard, Inc.
Cardiovascular · 146d
Cleared Dec 27, 1983
CARDIOTOMY RESERVOIR-FILTER 050-108-050
K832671 · DTN
Cobe Laboratories, Inc.
Cardiovascular · 140d
Cleared Dec 27, 1983
RMP INTUBATION EQUIP. STORAGE TRAY
K832697 · BZN
Rmp Co.
Anesthesiology · 139d
Cleared Dec 27, 1983
MUMPS COMPLEMENT FIXATION & HEMAGGLU
K832873 · GRC
Hazleton Dutchland, Inc.
Immunology · 124d
Cleared Dec 27, 1983
EBV-VCA-IGM IFA TEST SYSTEM
K833014 · LJN
Zeus Scientific, Inc.
Immunology · 112d
Cleared Dec 27, 1983
ALPHA Y-RECIPIENT SET
K833294 · BRZ
Alpha Therapeutic Corp.
General Hospital · 95d
Cleared Dec 27, 1983
BRONCHOSCOPY TUBE W/ULTRA LOCUFF
K833297 · BTS
Surgitek
Anesthesiology · 95d
Cleared Dec 27, 1983
DUOFLO 6F
K833303 · DQY
Argon Medical Corp.
Cardiovascular · 95d
Cleared Dec 27, 1983
PHADEBACK G.C. POSITIVE CONTROLS
K833307 · JSX
Pharmacia, Inc.
Microbiology · 95d
Cleared Dec 27, 1983
DUAL LUMEN NEEDLE
K833308 · KOC
Quinton, Inc.
Gastroenterology & Urology · 92d
Cleared Dec 27, 1983
N-ACETYLPROCAINAMIDE ACA-ANALYTICAL
K833378 · LAN
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
LIDOCAINE ANALYTICAL TEST PACK ACA
K833379 · KLR
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
LIDOAINE CALIBRATOR
K833380 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
VALPROIC ACID ANALYTICAL TEST PACK
K833381 · KLR
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
VALPROIC ACID CALIBRATOR
K833382 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
PROCAINAMIDE CALIBRATOR
K833383 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
PROCAINAMIDE ANALYTICAL TEST PACK
K833384 · LAR
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
HS4 HEAD/NECK FEMORAL PROSTHESES
K833461
Osteonics Corp.
Orthopedic · 83d
Cleared Dec 27, 1983
BDH UNIVERSAL HIP SYSTEM SURGEON
K833468 · JDG
Carbomedics, Inc.
Orthopedic · 82d