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

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175,820 results
149065–149088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 1985
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K850291 · JTZ
Remel Co.
Microbiology · 106d
Cleared May 10, 1985
PLASMA EXTRACTION SYSTEM
K850391 · JPI
Hans J. Brouwers & Assoc.
Hematology · 98d
Cleared May 10, 1985
SHEER ADHESIVE BANDAGES, STERILE
K850529 · KGX
Abco Dealers, Inc.
General & Plastic Surgery · 88d
Cleared May 10, 1985
THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY
K850543 · IWB
Atomic Energy of Canada
Radiology · 88d
Cleared May 10, 1985
WSP CODE 4315 PADTEST
K850693 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 78d
Cleared May 10, 1985
TAUCHER TUNNELER-PERIPHERAL VASCULAR SURG-INSTRUME
K850764
Aston & Aston
General & Plastic Surgery · 74d
Cleared May 10, 1985
COBAS CALIBRATOR SERUM
K850859 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared May 10, 1985
SPECTRA 1 FILTER PHOTOMETER
K850994 · JJQ
Awareness Technology, Inc.
Chemistry · 60d
Cleared May 10, 1985
SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P
K850995 · JJQ
Awareness Technology, Inc.
Chemistry · 60d
Cleared May 10, 1985
UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST
K851076 · JHI
United Biotech, Inc.
Chemistry · 53d
Cleared May 10, 1985
KEITH-A.R.V.
K851444 · KNT
Karl M. Block Co.
Gastroenterology & Urology · 29d
Cleared May 10, 1985
NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA
K851460 · BXY
Telectronics, Inc.
Anesthesiology · 29d
Cleared May 10, 1985
LD-1(IMMUNO) SEPARATION SET
K851521 · CEX
Seragen Diagnostics, Inc.
Chemistry · 25d
Cleared May 10, 1985
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K851542 · JJF
Alpkem Corp.
Chemistry · 24d
Cleared May 10, 1985
ULTRACLONE ECL-01-800 CELL LINE
K851545 · KIR
Earl-Clay Laboratories, Inc.
Pathology · 24d
Cleared May 10, 1985
WI-38 GENCELLS
K851561 · KIR
Genus Diagnostics
Pathology · 24d
Cleared May 10, 1985
MRC-5 GENCELLS
K851562 · KIR
Genus Diagnostics
Pathology · 24d
Cleared May 10, 1985
RK GENCELLS
K851563 · KIR
Genus Diagnostics
Pathology · 24d
Cleared May 10, 1985
EMIT 700 BENZODIAZEPINE ASSAY
K851568 · JXM
Syva Co.
Toxicology · 24d
Cleared May 10, 1985
THIOGLYCOLLATE WITHOUT INDICATOR
K851598 · JSG
Preferred Micro-Media
Microbiology · 24d
Cleared May 10, 1985
SPIROMED 2
K851620 · BZG
Draeger Medical, Inc.
Anesthesiology · 22d
Cleared May 10, 1985
BOOM ARM
K851621 · BSZ
Draeger Medical, Inc.
Anesthesiology · 22d
Cleared May 10, 1985
DEMAND MAGNESIUM
K851657 · JGJ
Cooper Biomedical, Inc.
Chemistry · 17d
Cleared May 10, 1985
CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/
K851670 · JIT
Medical Analysis Systems, Inc.
Chemistry · 17d