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
158929–158952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1982
REPLAM HYDROXYAPATATITE
K822420 · FMF
Replam Corp.
General Hospital · 47d
Cleared Sep 28, 1982
PROTEMP
K822452 · EBG
Espe GmbH (Us)
Dental · 43d
Cleared Sep 28, 1982
COVALENT COAT RIA KIT
K822509 · CFP
Immuchem Corp.
Chemistry · 39d
Cleared Sep 28, 1982
MODEL UCG ASSAY
K822520 · JHI
Monoclonal Antibodies, Inc.
Chemistry · 36d
Cleared Sep 28, 1982
CUTANEOUS PRESSURE PLETHYSMOGRAPH
K822522 · DSB
Life Sciences Manufacturing, Inc.
Cardiovascular · 36d
Cleared Sep 28, 1982
MULTIPLE, ENT CABINET #448
K822531 · ETF
Midmark Corp.
Ear, Nose, Throat · 36d
Cleared Sep 28, 1982
MARK V
K822536 · DXT
Medrad, Inc.
Cardiovascular · 35d
Cleared Sep 28, 1982
NEEDLE CATHETER JEJUNOSTOMY KIT
K822565 · KNT
Bio-Research Associates, Inc.
Gastroenterology & Urology · 37d
Cleared Sep 28, 1982
LITHOTRIPTOR ELECTRODE 4.5F
K822585 · FFK
Monaghan Medical Corp.
Gastroenterology & Urology · 33d
Cleared Sep 28, 1982
PERCUTANEOUS CATHETER INTRODUCER SET
K822593 · DYB
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
POLYETHYLENE CARDIOVASCULAR CATHETER
K822594 · DQO
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
VESSEL DILATOR
K822595 · DRE
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS
K822598 · DQO
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
ACID FAST QUALITY CONTROL SLIDES
K822604 · LJG
Medastat Scientific Corp.
Chemistry · 32d
Cleared Sep 28, 1982
ROOT CANAL REAMERS, TYPE K
K822620 · EKP
Union Broach, Div. Moyco Industries,...
Dental · 29d
Cleared Sep 28, 1982
ROOT CANAL FILES, TYPE K
K822621 · EKS
Union Broach, Div. Moyco Industries,...
Dental · 29d
Cleared Sep 28, 1982
ROOT CANAL FILES, TYPE H (HEDSTROM
K822622 · EKS
Union Broach, Div. Moyco Industries,...
Dental · 29d
Cleared Sep 28, 1982
NASAL SEPTAL BUTTONS
K822637 · LFB
Abco Dealers, Inc.
Ear, Nose, Throat · 28d
Cleared Sep 28, 1982
CORONARY INFUSION KIT
K822640 · DQO
Mallinckrodt Critical Care
Cardiovascular · 27d
Cleared Sep 28, 1982
TDX QUINIDINE
K822653 · LBZ
Abbott Laboratories
Toxicology · 26d
Cleared Sep 28, 1982
EMIT-AMD AMIKACIN ASSAY
K822657 · KLQ
Dade Behring, Inc.
Chemistry · 25d
Cleared Sep 28, 1982
CONCLUDE COMPOSITE LUTING CEMENT
K822714 · EBD
3M Company
Dental · 21d
Cleared Sep 28, 1982
ERIE OXYGEN CONCENTRATOR
K822719
Erie Controls
Cardiovascular · 21d
Cleared Sep 28, 1982
RESCUER
K822727 · CAE
Armstrong Ind., Inc.
Anesthesiology · 20d