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
174985–175008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1976
CATHETER 3-WAY SILICONE FOLEY
K760259 · KOD
Travenol Laboratories, S.A.
Gastroenterology & Urology · 34d
Cleared Aug 23, 1976
ELCTROCARDIOGRAPH, EK-6
K760265 · DPS
Burdick Corp.
Cardiovascular · 32d
Cleared Aug 23, 1976
ELECTRODE SERIES 1401
K760280 · DRX
Andover Medical, Inc.
Cardiovascular · 31d
Cleared Aug 23, 1976
SIGMA AMMONIA REAGENT
K760332 · JIF
Sigma Chemical Co.
Chemistry · 26d
Cleared Aug 23, 1976
CATHETER, ARGYLE THORACIC
K760351 · DWS
Sherwood Medical Industries
Cardiovascular · 21d
Cleared Aug 23, 1976
ELECTRODE SERIES 1600
K760358 · DRX
Andover Medical, Inc.
Cardiovascular · 21d
Cleared Aug 23, 1976
INFUSION EQUIPMENT, INTRAVENOUS
K760370 · FRN
Valleylab, Inc.
General Hospital · 18d
Cleared Aug 23, 1976
CEMENT, RESIN DENTAL (SOLO-TACH)
K760376 · DYH
L.D. Caulk Co.
Dental · 18d
Cleared Aug 23, 1976
FILLING, RESIN DENTAL (VYTOL)
K760377 · EBF
L.D. Caulk Co.
Dental · 18d
Cleared Aug 23, 1976
CEMENT, RESIN DENTAL (AUTO-TACH)
K760378 · DYH
L.D. Caulk Co.
Dental · 18d
Cleared Aug 23, 1976
DENTAL AMALGAM ALLOY (SPHERICAL II)
K760379 · EJS
L.D. Caulk Co.
Dental · 18d
Cleared Aug 23, 1976
BED PAN, STACKABLE (AUTOCLAVABLE)
K760393 · FOB
Bemis Health Care
General Hospital · 17d
Cleared Aug 23, 1976
BONDING AGENT, VYTOL
K760400 · KLE
L.D. Caulk Co.
Dental · 17d
Cleared Aug 23, 1976
SYRINGE SET, 3-WAY THERMODILUTIN
K760402 · DQO
Omp Laboratories, Inc.
Cardiovascular · 17d
Cleared Aug 23, 1976
TEMPORARY ATRIAL ELECTRODE KIT
K760403 · DRE
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Aug 23, 1976
BI-CENTRIC SYSTEM
K760404 · KLC
Pelton & Crane Co.
Dental · 14d
Cleared Aug 23, 1976
SEALANT, NEW FILLED
K760405 · EBC
L.D. Caulk Co.
Dental · 14d
Cleared Aug 23, 1976
TAPE, LIGHTCAST II WB
K760413 · ITG
Solar Laboratories, Inc.
Physical Medicine · 14d
Cleared Aug 23, 1976
DATA-TOPE SYSTEM DIGOXIN RIA
K760416 · DOG
Dade, Baxter Travenol Diagnostics, Inc.
Toxicology · 14d
Cleared Aug 23, 1976
LEE-FILL ULTRAVIOLET-CURED REST. MAT.
K760417 · EBF
Lee Pharmaceuticals
Dental · 14d
Cleared Aug 23, 1976
9075
K760418 · EBC
Lee Pharmaceuticals
Dental · 14d
Cleared Aug 23, 1976
ADHESION PROMOTOR
K760419 · EBD
Lee Pharmaceuticals
Dental · 14d
Cleared Aug 23, 1976
FILTER, VACUUM LINE LINEGUARD
K760420 · KPQ
Diemolding Corp.
Radiology · 17d
Cleared Aug 23, 1976
THERMOMETER, SURVALENT-ELECTRONIC
K760421 · FLL
Arbrook Mfg. Corp.
General Hospital · 13d