FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
172705–172728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 02, 1977
MULTISTAT III TRIGLYCERIDE TEST
K771472 · CDT
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Sep 02, 1977
LAS-R HUMAN CRP TEST
K771535 · DCN
Hyland Therapeutic Div., Travenol...
Immunology · 23d
Cleared Sep 02, 1977
SUTURE RETENTION CLAMP
K771554 · KGS
Concept, Inc.
General & Plastic Surgery · 21d
Cleared Sep 02, 1977
PHADEBAS RAST PENICLLOYL G/V TEST
K771578 · DHB
Pharmacia, Inc.
Microbiology · 15d
Cleared Sep 02, 1977
TEKTALLY II
K771580 · GKM
Scientific Products
Hematology · 15d
Cleared Sep 02, 1977
FLUORESCENT ANTI. ANTI-HUMAN C3
K771583 · DAC
Burroughs Wellcome Co.
Microbiology · 15d