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

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176,076 results
158497–158520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 1983
MOTILITY CATHETERS
K823701 · FFX
Mui Scientific
Gastroenterology & Urology · 69d
Cleared Feb 15, 1983
MF 360B ELECTROSURGICAL UNIT
K823923 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 49d
Cleared Feb 15, 1983
HIPUSH HANDHELD MASSAGER
K823927 · ISA
New Age Corp.
Physical Medicine · 48d
Cleared Feb 15, 1983
LITH A TEST TM
K830091 · CEN
Lenal Creative Approaches, Inc.
Hematology · 35d
Cleared Feb 15, 1983
MS-2 BACTERIAL IDENTI. SYS
K830099 · JTO
Abbott Laboratories
Microbiology · 35d
Cleared Feb 15, 1983
QUIK-DIP BLOOD STAIN
K830127 · IAF
Mercedes Scientific Co., Inc.
Pathology · 34d
Cleared Feb 15, 1983
MICRO 2 HYPODERMIC NEEDLES
K830242 · FMI
Smith & Nephew, Mpl Division
General Hospital · 21d
Cleared Feb 15, 1983
CENTAURSET 300 & 300 P.E.D
K830258 · FPA
Centaur Sciences, Inc.
General Hospital · 21d
Cleared Feb 14, 1983
SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT
K827346
Rayflow Italia S.R.L.
Radiology · 54d
Cleared Feb 10, 1983
SALMONELLA-SHIGELLA AGAR
K830065 · JSI
bioMerieux, Inc.
Immunology · 30d
Cleared Feb 10, 1983
BILE ESCULIN AZIDE AGAR
K830080 · JSJ
bioMerieux, Inc.
Immunology · 30d
Cleared Feb 10, 1983
BIGGY AGAR
K830082 · JSI
bioMerieux, Inc.
Immunology · 30d
Cleared Feb 09, 1983
3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
K813265 · KGX
3M Company
General & Plastic Surgery · 446d
Cleared Feb 09, 1983
APSARA CLINICAL DIAG. & INFO. SYS
K823386 · JJE
Datachem, Inc.
Chemistry · 86d
Cleared Feb 09, 1983
MODEL EM-2 BIOELECTRIC PROCESSOR
K830034 · KZM
Myo-Tronics Research, Inc.
Dental · 33d
Cleared Feb 09, 1983
MUELLER HINTON W/50% SHEEP BLOOD
K830059 · JTC
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
MUELLER HINTON
K830060 · JTZ
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
THAYER-MARTIN, MODIFIED
K830061 · JTY
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
MARTIN-LEWIS AGAR
K830062 · JTY
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
CONTACT PLATE LECITHIN & POLYSORBATE 80
K830063 · JSG
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
XLD AGAR
K830064 · JSI
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
SABOURAND DEXTROSE AGAR
K830066 · JSJ
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
PHENYLETHANOL AGAR W/50% SHEEP BLOOD
K830067 · JSJ
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
NUTRIENT AGAR
K830068 · JSG
bioMerieux, Inc.
Immunology · 29d