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
135073–135096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 1988
MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER
K882063 · EGG
Zest Anchors, Inc.
Dental · 28d
Cleared Jun 13, 1988
DENTORIDGE(TM) HYDROXYYLAPATITE
K882098 · LYC
Norian Corp.
Dental · 25d
Cleared Jun 13, 1988
JEL-5 GOLD BASED ALLOYS & PRECIOUS METAL ALLOYS
K882126 · EJT
J.F. Jelenko & Co., Inc.
Dental · 24d
Cleared Jun 10, 1988
SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD
K864159 · CHH
Chem-Elec, Inc.
Chemistry · 596d
Cleared Jun 10, 1988
AMBULATORY BLOOD PRESSURE MONITOR
K873764 · DXN
Pulsetrend, Inc.
Cardiovascular · 268d
Cleared Jun 10, 1988
JETPOLISHER(TM)
K875340 · KOJ
Young Dental Manufacturing Co. 1, LLC
Dental · 163d
Cleared Jun 10, 1988
VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT
K880041 · DSY
D-R Medical Systems, Inc.
Cardiovascular · 157d
Cleared Jun 10, 1988
DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL
K880289 · DSP
Datascope Corp.
Cardiovascular · 137d
Cleared Jun 10, 1988
MODEL 800 O.B. DATA ARCHIVAL SYSTEM
K880419 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 130d
Cleared Jun 10, 1988
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
K880576 · CJY
Reagents Applications, Inc.
Chemistry · 121d
Cleared Jun 10, 1988
AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM
K880839 · IYO
Phoenix Imaging
Radiology · 101d
Cleared Jun 10, 1988
UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.
K881122 · BTY
Medical Associated Services, Inc.
Anesthesiology · 86d
Cleared Jun 10, 1988
HDL CHOLESTEROL KIT
K881244 · LBR
Trace Scientific , Ltd.
Chemistry · 79d
Cleared Jun 10, 1988
MODEL 9216 RESPIRATION/HEART RATE MONITOR
K881266 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 78d
Cleared Jun 10, 1988
COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK
K881330 · DWF
Cobe Laboratories, Inc.
Cardiovascular · 73d
Cleared Jun 10, 1988
OXY-CATH
K881428 · BSY
Pulmonary Medical Devices, Inc.
Anesthesiology · 66d
Cleared Jun 10, 1988
T.E.N.S. ELECTRODE NON-STERILE
K881444 · GXY
Tens Accessories, Inc.
Neurology · 65d
Cleared Jun 10, 1988
SIMPLEX UNIVERSAL HEATED TUBING SLEEVE
K881451 · BZE
Simplex Medical Corp.
Anesthesiology · 65d
Cleared Jun 10, 1988
MAMEX DC MG11
K881505 · IZH
Orion Corp.
Radiology · 60d
Cleared Jun 10, 1988
MAMEX DC MAG MG12
K881506 · IZH
Orion Corp.
Radiology · 60d
Cleared Jun 10, 1988
HUMID-VENT 2 S
K881644 · BYD
Gibeck Respiration
Anesthesiology · 56d
Cleared Jun 10, 1988
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
K881760 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 46d
Cleared Jun 10, 1988
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
K881773 · JJR
Casco Standards
Chemistry · 45d
Cleared Jun 10, 1988
IMMUNOGLOBULIN A TEST SYSTEM
K881827 · CFQ
The Binding Site, Ltd.
Immunology · 42d