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
151849–151872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1984
48 HOUR BIOLOGICAL INDICATORS SPORSTRIP
K841709 · FRC
Skyland Scientific Services, Inc.
General Hospital · 162d
Cleared Oct 02, 1984
CATH-TECH CHOLANGIOGRAPHY CATHETER
K842147 · FGE
Catheter Technology Corp.
Gastroenterology & Urology · 125d
Cleared Oct 02, 1984
DIAFLEX NEPHROSTOMY BALLOON DILATOR
K842206 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 120d
Cleared Oct 02, 1984
HEMODIAL CONCENTRATE MIXING APPARATUS
K842225 · FKQ
Lmf Medical Research & Manufacturing,...
Gastroenterology & Urology · 119d
Cleared Oct 02, 1984
DORR HIP PROSTHESIS FEMORAL COMPONENT
K842360 · JDI
Carbomedics, Inc.
Orthopedic · 117d
Cleared Oct 02, 1984
METER MOUSE SYSTEM
K842599
Mem, Inc.
Radiology · 91d
Cleared Oct 02, 1984
DILATOR/SHEATH SET
K842632 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 88d
Cleared Oct 02, 1984
AMER. EDWARDS LAB DIAFLEX URETERAL DILA
K842639 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 85d
Cleared Oct 02, 1984
ESOPHAGEAL DILATOR SET
K842679 · FAT
Mill-Rose Laboratory
Gastroenterology & Urology · 84d
Cleared Oct 02, 1984
LASER FOR GENITOURINARY APPLIC. 4000
K843240 · LNK
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 41d
Cleared Oct 02, 1984
ND-YAG LASER FOR UROLOGICAL SURGERY
K843293 · LNK
Endo Lase, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 02, 1984
ND-YAG LASER FOR PALLIATION OF GI MALIGN
K843374 · LNK
Endo Lase, Inc.
Gastroenterology & Urology · 35d
Cleared Oct 02, 1984
HARRIS HEMATOXYLIN, MERCURY FREE, ACID
K843425 · HYK
Accra Laboratories, Inc.
Pathology · 28d
Cleared Oct 02, 1984
GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6
K843427 · HZJ
Accra Laboratories, Inc.
Pathology · 28d
Cleared Oct 02, 1984
NEOMYCIN BLOOD AGAR
K843492 · JSI
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Oct 02, 1984
DIFFERENTIATION DISKS NITRATE
K843521 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Oct 02, 1984
TSH QUIK RIA KIT
K843545 · JLW
Pacific Biotech, Inc.
Chemistry · 22d
Cleared Oct 01, 1984
E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE
K842121 · LJE
E-Z-Em, Inc.
Gastroenterology & Urology · 125d
Cleared Oct 01, 1984
GORE-TEX VASCULAR GRAFT, FEP-RINGED
K842144 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 124d
Cleared Oct 01, 1984
AMERICAN MEDICAL OPTICS I/A KIT- IRRIG
K842197 · HQE
American Medical Optics
Ophthalmic · 119d
Cleared Oct 01, 1984
MICROMEDICS SURGICAL INSTRUMENTS
K842212
Micromedics, Inc.
Gastroenterology & Urology · 119d
Cleared Oct 01, 1984
SUR-FIT IRRIGATION ADAPTER FACEPLATE
K842398 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 104d
Cleared Oct 01, 1984
AMER. MEDICAL OPTICS DIGITAL KERATO-
K842504 · HQL
American Medical Optics
Ophthalmic · 97d
Cleared Oct 01, 1984
AMIZYME-C TRACHOMATIS TEST KIT
K842525 · LJP
Amico Lab, Inc.
Immunology · 95d