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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
110953–110976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1993
CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY
K934562 · CDZ
Ciba Corning Diagnostics Corp.
Chemistry · 85d
Cleared Dec 10, 1993
IMMUNLITE INTACT PTH
K934760 · CEW
Diagnostic Products Corp.
Chemistry · 67d
Cleared Dec 10, 1993
ARGELITE 81SF+
K934768 · EJH
Argen Precious Metals, Inc.
Dental · 66d
Cleared Dec 10, 1993
ARGELITE A
K934773 · EJS
Argen Precious Metals, Inc.
Dental · 66d
Cleared Dec 10, 1993
VALVE SIZER
K934951 · DTI
Carbomedics, Inc.
Cardiovascular · 53d
Cleared Dec 10, 1993
DUET
K934970 · GBJ
Trulife , Ltd.
General & Plastic Surgery · 53d
Cleared Dec 10, 1993
FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL
K934978 · EBG
Ivoclar North America, Inc.
Dental · 52d
Cleared Dec 10, 1993
SIROLUX FANTASTIC
K935390 · EAZ
Pelton & Crane Co.
Dental · 32d
Cleared Dec 09, 1993
FLUORESCENT T12 UVA TANNING LAMP
K923759 · LEJ
Quality Lamp, Inc.
General & Plastic Surgery · 499d
Cleared Dec 09, 1993
A-DEC 2170 DUO UNIT CUSP
K925314 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2171 DUO UNIT
K925315 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2172 DOCTOR'S UNIT
K925316 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2180 DUO UNIT, CUSP
K925317 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2181 DUO UNIT
K925318 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2182 DOCTOR'S UNIT
K925319 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2145 DUO UNIT, CUSP
K925320 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2146 DUO UNIT
K925321 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2147 DOCTOR'S UNIT
K925322 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2183 DUO UNIT, CUSP
K925323 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2184 DUO UNIT
K925324 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2185 DOCTOR'S UNIT
K925325 · KLC
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
MEDIX PHOTOTHERAPY LAMP
K931965 · LBI
Medix I.C.S.A.
General Hospital · 231d
Cleared Dec 09, 1993
LAPAROSCOPY OPTICS
K932321 · GCJ
Medline Industries, Inc.
General & Plastic Surgery · 212d
Cleared Dec 09, 1993
SUNBRONZE TANNING LAMPS
K932418 · LEJ
Ess Lighting
General & Plastic Surgery · 205d