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
126913–126936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1990
TELEREHAB SYSTEM FOR CARDIAC REHABILITATION
K895719 · DXH
Scottcare Corp.
Cardiovascular · 162d
Cleared Mar 06, 1990
CAPTIA(R) CMV-G
K896194 · LFZ
Mercia Diagnostics , Ltd.
Microbiology · 132d
Cleared Mar 06, 1990
CAPTIA(R) CMV-M
K896295 · LFZ
Mercia Diagnostics , Ltd.
Microbiology · 126d
Cleared Mar 06, 1990
MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
K896313 · DTB
Medtronic Vascular
Cardiovascular · 125d
Cleared Mar 06, 1990
MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM
K896403 · LIT
Intensive Technology, Inc.
Cardiovascular · 119d
Cleared Mar 06, 1990
PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT
K896482 · LCX
Pacific Biotech, Inc.
Chemistry · 113d
Cleared Mar 06, 1990
EXPLORER 24 DENTAL HAND INSTRUMENT
K896843 · EKJ
American Medical Ceramics, Inc.
Dental · 90d
Cleared Mar 06, 1990
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K896920 · DSP
Boston Scientific Corp
Cardiovascular · 84d
Cleared Mar 06, 1990
HYCOR ACCUPINCH COCAINE TEST
K896937 · DIO
Hycor Biomedical, Inc.
Toxicology · 83d
Cleared Mar 06, 1990
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
K896941 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 83d
Cleared Mar 06, 1990
RADIO-TEMP THERMOMETER
K896959 · FLL
Babymed Intl., Inc.
General Hospital · 82d
Cleared Mar 06, 1990
BLOOD PRESSURE CUFF
K896986 · DXQ
Latex Medical Devices, Inc.
Cardiovascular · 85d
Cleared Mar 06, 1990
IMMUNOTECH CHOLESTEROL TEST
K897036 · CHH
Immunotech Corp.
Chemistry · 78d
Cleared Mar 06, 1990
CARDIOCAP(TM) CT-104 MONITOR
K897080 · DRT
Datex Division Instrumentarium Corp.
Cardiovascular · 75d
Cleared Mar 06, 1990
SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR
K897082 · DQY
Schneider Intl., Ltd.
Cardiovascular · 76d
Cleared Mar 06, 1990
MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
K900031 · KNY
Porges Corp.
Gastroenterology & Urology · 61d
Cleared Mar 06, 1990
SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM
K900077 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 61d
Cleared Mar 06, 1990
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
K900377 · JPA
Baxter Healthcare Corp
Hematology · 39d
Cleared Mar 06, 1990
FACTOR V DEFICIENT PLASMA
K900406 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR VII DEFICIENT PLASMA
K900407 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR VIII DEFICIENT PLASMA
K900408 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR IX DEFICIENT PLASMA
K900409 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR X DEFICIENT PLASMA
K900410 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR XI DEFICIENT PLASMA
K900411 · GJT
Sigma Chemical Co.
Hematology · 36d