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
172033–172056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1977
SPINSEP-T3
K771854 · KHQ
Nuclear Diagnostics, Inc.
Immunology · 85d
Cleared Dec 22, 1977
LDH ISOENZYME CONTROL
K771894 · CEX
Bio-Reagents & Diagnostics, Inc.
Chemistry · 77d
Cleared Dec 22, 1977
EMIT CENTRIFICHEM THYROXINE ASSAY
K772170 · CDX
Syva Co.
Immunology · 31d
Cleared Dec 22, 1977
TRI-TAB-RIA
K772177 · CDP
Nuclear Medical Laboratories, Inc.
Immunology · 31d
Cleared Dec 22, 1977
X-RAY SYSTEM FOR DENTAL APPLICATION
K772184 · EAP
General Electric Co.
Radiology · 27d
Cleared Dec 22, 1977
FSH RIA KIT (125I)
K772188 · FSH
Diagnostic Products Corp.
Immunology · 27d
Cleared Dec 22, 1977
RECEPTAL ATS TRAUMA KGA1900L
K772196 · CAC
Sorensen Research
Hematology · 24d
Cleared Dec 22, 1977
TEMP. ACRYLIC
K772211 · EBG
Lactong Corp.
Dental · 21d
Cleared Dec 22, 1977
UNCONJUGATED ESTRIOL RIA KIT
K772215 · CGI
Amersham Corp.
Immunology · 20d
Cleared Dec 22, 1977
NEBULIZER SET-2C7105
K772222 · CAF
Travenol Laboratories, S.A.
Anesthesiology · 17d
Cleared Dec 22, 1977
TOXO TEST
K772243 · GLZ
Gull Laboratories, Inc.
Toxicology · 14d
Cleared Dec 22, 1977
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K772245 · DAD
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY
K772246 · DEB
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K772247 · DBI
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
ALBUMIN NEPHELOMETRIC ASSAY
K772248
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K772249 · CEW
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY
K772250 · DEI
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
IMMUNOGLOBULIN A NEPHEL. ASSAY
K772251 · CZP
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
IMMUNOGLOBULIN G NEPHEL. ASSAY
K772252 · DEW
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
TRANSFERRIN NEPHELOMETRIC ASSAY
K772253 · DDG
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
IMMUNOGLOBULIN M NEPHEL. ASSAY
K772254 · DFT
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
ALKALINE PHOSPHATASE TEST SET
K772257 · CIO
Stanbio Laboratory
Chemistry · 17d
Cleared Dec 22, 1977
125I DIGOXIN TEST SET
K772306 · DPB
Wien Laboratories, Inc.
Immunology · 7d
Cleared Dec 22, 1977
PCO 2 ELECTROLYTE
K772307 · CHL
Fisher Scientific Co., LLC
Chemistry · 6d