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
171769–171792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1978
IRON BINDING CAPACITY CHEMISTRY
K780094 · JMO
Harleco
Chemistry · 26d
Cleared Feb 13, 1978
ULTRAZYME PLUS ALP
K780095 · CJE
Harleco
Chemistry · 26d
Cleared Feb 13, 1978
ULTRAZYME PLUS GPT
K780102 · CKA
Harleco
Chemistry · 24d
Cleared Feb 13, 1978
ULTRAZYME PLUS GOT
K780103 · CIT
Harleco
Chemistry · 24d
Cleared Feb 13, 1978
ULTRAZYME PLUS HBD
K780104 · JMK
Harleco
Chemistry · 24d
Cleared Feb 13, 1978
CARDIAC PULSE GENERATOR, MODEL 160B
K780113 · DXY
Telectronics, Inc.
Cardiovascular · 25d
Cleared Feb 13, 1978
NEONATAL SCREENING AUDIOMETER
K780150 · EWO
Telediagnostic Systems, Inc.
Ear, Nose, Throat · 14d
Cleared Feb 13, 1978
RADIATION TREATMENT PLANNING SYSTEM
K780157 · JAD
Capintec, Inc.
Radiology · 14d
Cleared Feb 13, 1978
ANASWAB
K780159 · JTX
Scott Laboratories, Inc.
Microbiology · 14d
Cleared Feb 13, 1978
MASK, SURGICAL
K780169 · FXX
Convertors
General Hospital · 11d
Cleared Feb 13, 1978
TEST SYS. FOR NDNA ANTIBODY DETERM.
K780178 · DHN
Zeus Scientific, Inc.
Immunology · 10d
Cleared Feb 13, 1978
TOBRAMYCIN 125I RIA KIT
K780182 · DID
New England Nuclear
Microbiology · 10d
Cleared Feb 13, 1978
WHEELCHAIRS, MECHANICAL
K780183 · IOR
Orthopedic Equipment Co., Inc.
Physical Medicine · 10d
Cleared Feb 13, 1978
WHEELCHAIR ACCESSORIES
K780184 · IMX
Orthopedic Equipment Co., Inc.
Physical Medicine · 10d
Cleared Feb 07, 1978
THYROID STIMULATING HORMONE
K780015 · JLW
Pcl-Ria, Inc.
Immunology · 35d
Cleared Feb 07, 1978
THYRO-INDICATOR T-3 125I
K780018 · CDP
Clinical Immuno-Diagnostics
Immunology · 35d
Cleared Feb 07, 1978
ALP REAGENT SET
K780068 · CJE
Medical Analysis Systems, Inc.
Chemistry · 22d
Cleared Feb 07, 1978
LACTATE DEHYDROGENASE COLORIMETRIC SUB.
K780080 · CFE
Corning Medical & Scientific
Chemistry · 22d
Cleared Feb 07, 1978
ULTRACHEM ALBUMIN
K780092 · CIX
Harleco
Chemistry · 20d
Cleared Feb 07, 1978
IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER
K780161 · DHN
Zeus Scientific, Inc.
Immunology · 7d
Cleared Feb 06, 1978
ENDOCARDIAL PACING ELECTRODE
K772309 · DTB
Coratomic, Inc.
Cardiovascular · 59d
Cleared Feb 06, 1978
ANESTHESIA TRAY, CAUDAL
K780120 · CAZ
Kendall Research Center
Anesthesiology · 14d
Cleared Feb 06, 1978
IMPLANT, HINGE TOE, FLEX.
K780132 · KWH
Dow Corning Corp. Healthcare...
Orthopedic · 13d
Cleared Feb 06, 1978
ELBOW PROTECTOR
K780171 · FMP
Stat Medical Corp.
General Hospital · 4d