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
151393–151416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1984
CB FORMALIN
K842862 · IGE
Anatech, Ltd.
Pathology · 36d
Cleared Aug 28, 1984
CBA FORMALIN
K842940 · IFP
Anatech, Ltd.
Pathology · 34d
Cleared Aug 28, 1984
ALLERGENETICS ALLER-SPECIFIC IGE SERUM
K842969 · DGP
Allergenetics
Chemistry · 29d
Cleared Aug 28, 1984
RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA
K843085 · KIT
Sigma Chemical Co.
Microbiology · 22d
Cleared Aug 28, 1984
DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX
K843086 · KIT
Sigma Chemical Co.
Microbiology · 22d
Cleared Aug 27, 1984
FOGARTY OCCLUDER PAD
K831809 · DXC
Thomas J. Fogarty, M.D.
Cardiovascular · 448d
Cleared Aug 27, 1984
ANGIOGRAPHIC PROCEDURE TRAY
K840391 · DQX
Triad Medical Division
Cardiovascular · 210d
Cleared Aug 27, 1984
STROVER HOOK
K841617 · HCF
Plastafil, Inc.
General & Plastic Surgery · 130d
Cleared Aug 27, 1984
THREADING TUBE
K841618 · FZX
Plastafil, Inc.
General & Plastic Surgery · 130d
Cleared Aug 27, 1984
PROBE
K841624 · HRX
Plastafil, Inc.
Orthopedic · 130d
Cleared Aug 27, 1984
HOOK
K841625 · GAD
Plastafil, Inc.
General & Plastic Surgery · 130d
Cleared Aug 27, 1984
PUNCH
K841626 · HXG
Plastafil, Inc.
Orthopedic · 130d
Cleared Aug 27, 1984
MALLET
K841627 · HWA
Plastafil, Inc.
Orthopedic · 130d
Cleared Aug 27, 1984
DRILL BIT
K841629 · HTW
Plastafil, Inc.
Orthopedic · 130d
Cleared Aug 27, 1984
THE DENVER PLEURAL-PERITONEAL SHUNT
K842139 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 89d
Cleared Aug 27, 1984
PRESSURE MONITOR
K842194 · DXS
Norton Texas Medical Products
Cardiovascular · 84d
Cleared Aug 27, 1984
SERVOCARD DEFIBRILLATOR SCP-851
K842235 · LDD
Litton Datamedix
Cardiovascular · 83d
Cleared Aug 27, 1984
FLUID WARMER
K842302 · FLA
Organon Teknika Corp.
Gastroenterology & Urology · 77d
Cleared Aug 27, 1984
SERVOCARD SCP-840
K842312 · LDD
Litton Datamedix
Cardiovascular · 76d
Cleared Aug 27, 1984
ELECATH INFANT ARTERIAL & VENOUS CANNU
K842369 · BWF
Electro-Catheter Corp.
Anesthesiology · 73d
Cleared Aug 27, 1984
CARDIOTOMY RESERVOIR W/FILTER BCR-3500
K842620 · DTN
American Bentley
Cardiovascular · 53d
Cleared Aug 27, 1984
CARDIAC SUPPLY TRAY
K842645 · DQY
Deroyal Industries, Inc.
Cardiovascular · 48d
Cleared Aug 27, 1984
EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE
K842667 · LDD
Marquette Electronics, Inc.
Cardiovascular · 48d
Cleared Aug 27, 1984
BAIM CORONARY SINUS FLOW CALCULATOR
K842831 · DXG
Electro-Catheter Corp.
Cardiovascular · 38d