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
140737–140760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1987
DERATA MEDI-JECTOR IV
K864561 · KZE
Derata Corp.
General Hospital · 92d
Cleared Feb 19, 1987
MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT
K864565 · GQH
Serono Diagnostics, Inc.
Microbiology · 92d
Cleared Feb 19, 1987
Q700 ELECTROCARDIOGRAPH
K864700 · DPS
Quinton, Inc.
Cardiovascular · 79d
Cleared Feb 19, 1987
MODIFIED GAS-STAT(TM) MONITORING SYSTEM
K864703 · DTY
Cardiovascular Devices, Inc.
Cardiovascular · 79d
Cleared Feb 19, 1987
SCHNEIDER-SHILEY GUIDE WIRE
K864787 · DQX
Shiley, Inc.
Cardiovascular · 73d
Cleared Feb 19, 1987
STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP
K864890 · KRI
Shiley, Inc.
Cardiovascular · 66d
Cleared Feb 19, 1987
INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER
K864895 · DTN
Johnson & Johnson Professionals, Inc.
Cardiovascular · 66d
Cleared Feb 19, 1987
DENTAL HANDPIECES AND ATTACHMENT
K864922 · EKS
E&D Dental Manufacturing Co.
Dental · 65d
Cleared Feb 19, 1987
NUMED BALLOON ANGIOGRAPHIC CATHETERS
K864940 · DQO
NuMED, Inc.
Cardiovascular · 64d
Cleared Feb 19, 1987
OBERTO MOUTH PROP
K864962 · JXL
Medovations, Inc.
Neurology · 59d
Cleared Feb 19, 1987
APPLISCOPE
K864978 · DPS
Grandcor Medical Systems
Cardiovascular · 59d
Cleared Feb 19, 1987
ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
K864996 · ELC
Dentsply Intl.
Dental · 59d
Cleared Feb 19, 1987
ASTRA T2, T4 AND T6
K865013 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 58d
Cleared Feb 19, 1987
AUSTENAL CONDENSING INSTRUMENT
K865025 · EKG
Austenal Dental, Inc.
Dental · 58d
Cleared Feb 19, 1987
ESPE CHELON-SILVER
K865028 · EBF
Espe GmbH (Us)
Dental · 58d
Cleared Feb 19, 1987
ELECTROCARDIOGRAPH
K865031 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Feb 19, 1987
PREGELLED DISPOS. ELECTRODE,SILVER-SILVER CHLORIDE
K865090
Labeltape Meditect, Inc.
Cardiovascular · 51d
Cleared Feb 19, 1987
DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM
K870130 · ELR
Den-Mat Corp.
Dental · 38d
Cleared Feb 19, 1987
DURA ORTHO ACRYLIC
K870148 · EBI
Reliance Dental Mfg. Co.
Dental · 37d
Cleared Feb 19, 1987
ENDOBRUSH
K870177 · EKS
C & S Microinstruments , Ltd.
Dental · 35d
Cleared Feb 19, 1987
NEXADENT (DENTAL CEMENT)
K870209 · EMA
Bionexus, Inc.
Dental · 30d
Cleared Feb 19, 1987
BOSTON POST CEMENT
K870334 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 22d
Cleared Feb 19, 1987
GEM ORTHODONTIC BRACKET
K870536 · EJF
Ormco Corp.
Dental · 10d
Cleared Feb 19, 1987
X-RAY APRON
K870563 · EAJ
X-Tech, Ltd.
Radiology · 9d