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
140881–140904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1987
FRANTZ MEDICAL ELECTRODE
K863508 · DXR
Frantz Medical Development, Ltd.
Cardiovascular · 150d
Cleared Feb 06, 1987
EVIDENT MARK 2 APEX LOCATOR
K863834
Pulpdent Corp. of America
Dental · 129d
Cleared Feb 06, 1987
DPC COAT-A-COUNT IRMA LH KIT
K863934 · CEP
Diagnostic Products Corp.
Chemistry · 120d
Cleared Feb 06, 1987
MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP
K864327 · FRW
Medtronic Minimed
General Hospital · 94d
Cleared Feb 06, 1987
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K864357 · CIT
Trace Scientific , Ltd.
Chemistry · 95d
Cleared Feb 06, 1987
CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)
K864359 · CGS
Trace Scientific , Ltd.
Chemistry · 95d
Cleared Feb 06, 1987
LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE
K864360
Trace Scientific , Ltd.
Chemistry · 95d
Cleared Feb 06, 1987
SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE
K864444 · ETA
Richards Medical Co., Inc.
Ear, Nose, Throat · 86d
Cleared Feb 06, 1987
THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM)
K864448 · KPN
Biosonics, Inc.
Gastroenterology & Urology · 86d
Cleared Feb 06, 1987
UV VISIBLE SPECTROPHOTOMETERS
K864451 · JJQ
Trans-National Trade Development Corp.
Chemistry · 86d
Cleared Feb 06, 1987
ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER
K864532 · JPA
Medical Laboratory Automation...
Hematology · 81d
Cleared Feb 06, 1987
ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER
K864534 · JPA
Medical Laboratory Automation...
Hematology · 81d
Cleared Feb 06, 1987
ARTEL DIFFERENTIAL PHOTOMETER
K864542 · JJQ
Artel, Inc.
Chemistry · 79d
Cleared Feb 06, 1987
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
K864664 · KSA
Technicon Instruments Corp.
Hematology · 70d
Cleared Feb 06, 1987
ANATOMIC MODULAR KNEE (AMK) SYSTEM
K864671 · JWH
Depuy, Inc.
Orthopedic · 66d
Cleared Feb 06, 1987
NAMIC CHIBA ASPIRATION BIOPSY NEEDLE
K864800 · GAA
North American Instrument Corp.
General & Plastic Surgery · 59d
Cleared Feb 06, 1987
IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS
K865000 · LET
Sclavo, Inc.
Toxicology · 46d
Cleared Feb 06, 1987
A-BEC FIREBALL 40
K865001 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 18
K865002
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 46
K865003 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 40 POWER WHEELCHAIR
K865004 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 41
K865005 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 14
K865006 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 15
K865007 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d