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
160945–160968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1982
KNEE SUPPORT FOR X-RAY & SURGERY
K820291 · FWZ
The Anspach Effort, Inc.
General & Plastic Surgery · 30d
Cleared Mar 05, 1982
RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC
K820306 · KPW
Tecnomed, Inc.
Radiology · 29d
Cleared Mar 05, 1982
TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE
K820307 · IZO
Tecnomed, Inc.
Radiology · 29d
Cleared Mar 05, 1982
SPECTRA (ULTRAVIOLET PRODUCTS)
K827123
Ultralite
Radiology · 31d
Cleared Mar 05, 1982
RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHIC
K827124
Tecnomed, Inc.
Radiology · 29d
Cleared Mar 05, 1982
TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE
K827126
Tecnomed, Inc.
Radiology · 29d
Cleared Mar 04, 1982
SUNGLASSES
K813130 · HQG
Panlin Corp.
Ophthalmic · 119d
Cleared Mar 04, 1982
GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
K813342 · KSK
Gamma Biologicals, Inc.
Chemistry · 99d
Cleared Mar 04, 1982
LECTIN H
K813413 · KSI
American Dade
Pathology · 87d
Cleared Mar 04, 1982
ROCKING/CIRCULATING CYTO-THERM II 3570
K813489 · KZL
Cryosan, Inc.
Hematology · 93d
Cleared Mar 04, 1982
ENZYGNOST TM RUBELLA IGM
K813493 · LFX
Calbiochem-Behring Corp.
Immunology · 80d
Cleared Mar 04, 1982
FE-CULT PLUS
K820072 · KHE
Gamma Biologicals, Inc.
Hematology · 51d
Cleared Mar 04, 1982
FROSTED GLASS SLIDES
K820100 · KEW
Stan-Pak Ent.
Pathology · 50d
Cleared Mar 04, 1982
PI808 MOBILE C-ARM IMAGE INTENSIFIER
K820178 · JAA
Precise Optics
Radiology · 41d
Cleared Mar 04, 1982
DIGICUFF
K820242 · DXN
Novatec, Inc.
Cardiovascular · 34d
Cleared Mar 04, 1982
CIN AGAR BASE
K820295 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 29d
Cleared Mar 04, 1982
RALCO COLLIMATORS, MANUAL RADIOGRAPHIC
K820305 · KPW
Tecnomed, Inc.
Radiology · 28d
Cleared Mar 04, 1982
ANA-DISC SYSTEM
K820308 · KZJ
Flow Laboratories, Inc.
Microbiology · 28d
Cleared Mar 04, 1982
ESTRADIOL KIT BY RIA
K820329 · CHP
Immuchem Corp.
Chemistry · 24d
Cleared Mar 04, 1982
T3 UPTAKE-SQUIBB DIAGNOSTIC KIT
K820340 · KHQ
E. R. Squibb & Sons, Inc.
Toxicology · 24d
Cleared Mar 04, 1982
CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT
K820341 · CGR
E. R. Squibb & Sons, Inc.
Toxicology · 24d
Cleared Mar 04, 1982
PHYSIOLOGICAL PRESSURE TRANSDUCER #900
K820342 · DRS
Bentley Laboratories, Inc.
Cardiovascular · 24d
Cleared Mar 04, 1982
CALI-LOOP
K820345 · LIB
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 24d
Cleared Mar 04, 1982
CALI-PIPETTE
K820346 · LIB
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 24d