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
173545–173568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1977
ARTEOIAL TONOMETER ML-105
K771449 · DXN
Nicolet Biomedical Instruments
Cardiovascular · 35d
Cleared Sep 06, 1977
LAPAROTOMY SPONGES
K771531 · EFQ
Surgilite Intl., Inc.
General & Plastic Surgery · 28d
Cleared Sep 06, 1977
AQUAMATIC K-MODULE MODEL K-20
K771537 · DWJ
Gorman Rupp Industries
Cardiovascular · 26d
Cleared Sep 06, 1977
ELECTRONIC EIPLATOR MODEL NO. 101
K771575 · KCX
Electronic Depilatory, Inc.
General & Plastic Surgery · 21d
Cleared Sep 06, 1977
PROTECTOR
K771611 · MMK
Richard-Allan Medical Ind., Inc.
General Hospital · 15d
Cleared Sep 06, 1977
COPE LUNG FORCEPS #305-218
K771624 · GEN
J. Jamner Surgical Instruments, Inc.
General & Plastic Surgery · 12d
Cleared Sep 06, 1977
NIMETICAP
K771654 · EBF
Espe GmbH (Us)
Dental · 8d
Cleared Sep 02, 1977
HYPRONOSTICON TM
K770603 · JMM
Organon, Inc.
Chemistry · 156d
Cleared Sep 02, 1977
BIO-SHIELD CSR WRAP
K770933 · FRG
Convertors
General Hospital · 102d
Cleared Sep 02, 1977
TRIGLYCERIDE REAGENT SET
K770993 · CDT
Macomb Chemical Co.
Chemistry · 93d
Cleared Sep 02, 1977
3-(N-MORPHOLINS)-PROPANE SULFONIC ACID
K771324 · JHX
Corning Medical & Scientific
Chemistry · 46d
Cleared Sep 02, 1977
THYRODOT-4, THYRODOT-SH
K771377 · JLW
Medcom Diagnostics, Inc.
Chemistry · 39d
Cleared Sep 02, 1977
IMMUNOSTAT T3 UPTAKE TEST
K771382
Meloy Laboratories, Inc.
Chemistry · 38d
Cleared Sep 02, 1977
AMYLASE ULTRAZYME PLUS
K771388 · JFJ
Harleco
Chemistry · 37d
Cleared Sep 02, 1977
CK-1 ULTRAZYME PLUS
K771389 · CGS
Harleco
Chemistry · 37d
Cleared Sep 02, 1977
RHEUMANOSTICON R
K771410 · DHR
Organon, Inc.
Immunology · 32d
Cleared Sep 02, 1977
SERONORM
K771436 · JJT
Nyegaard & Co. A/S
Chemistry · 32d
Cleared Sep 02, 1977
SERONORM LIPID
K771437 · JJY
Nyegaard & Co. A/S
Chemistry · 32d
Cleared Sep 02, 1977
AUTONORM
K771438 · JJT
Nyegaard & Co. A/S
Chemistry · 32d
Cleared Sep 02, 1977
PATHONORM H & L
K771439 · JJT
Nyegaard & Co. A/S
Chemistry · 32d
Cleared Sep 02, 1977
MULTISTAT III GLUCOSE TEST
K771464 · CFR
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Sep 02, 1977
MULTISTAT III LACTIC DEHYDROGENASE
K771465 · CFJ
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Sep 02, 1977
MULTISTAT III ALANINE AMINOTRANSFERASE
K771466 · CKA
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Sep 02, 1977
MULTISTAT III ASPARTATE AMINOTRANSFERASE
K771467
Instrumentation Laboratory CO
Chemistry · 29d