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
163465–163488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1981
OMNI
K811158 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 29d
Cleared May 27, 1981
DYNASOUND 801
K811159 · IMI
Dynawave, Corp.
Physical Medicine · 29d
Cleared May 27, 1981
URETHANE ORTHOPAEDIC CASTING TAPE
K811164 · ITG
Hexcel Medical
Physical Medicine · 29d
Cleared May 27, 1981
VASCULON II I.V. CATHETER
K811171 · FOZ
Pioneer Viggo, Inc.
General Hospital · 29d
Cleared May 27, 1981
RECOH ROOT CANAL IRRIGATOR
K811175 · EFS
Koei International, Inc.
Dental · 29d
Cleared May 27, 1981
MEDTRONIC A2 CLINICAL IMAGING SYSTEM
K811187 · IYX
Medtronic Vascular
Radiology · 28d
Cleared May 27, 1981
DAVIS & GECK NEEDLE/SHARPS COUNTER
K811191 · KDC
Davis & Geck, Inc.
General & Plastic Surgery · 27d
Cleared May 27, 1981
HITACHI 705 AUTOMATIC BLOOD CHEMISTRY
K811194 · JJE
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared May 27, 1981
ULTRACHEM GLUC-DH, ITEM NO. 65048
K811202 · LFR
Harleco
Chemistry · 26d
Cleared May 27, 1981
INTERMEDICS CYBERLITH BIPOLAR CARDIAC
K811221 · DXY
Intermedics, Inc.
Cardiovascular · 23d
Cleared May 27, 1981
BODAI SUCTION -SAFE 4
K811241 · BSY
Sontek Industries, Inc.
Anesthesiology · 23d
Cleared May 27, 1981
CORNING 965 CARBON DIOXIDE ANALYZER
K811257 · CHS
Corning Medical & Scientific
Chemistry · 22d
Cleared May 27, 1981
BARALYME CO2 ABSORBENT
K811260 · CBL
Allied Healthcare Products, Inc.
Chemistry · 21d
Cleared May 27, 1981
EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI
K811262 · JRY
Zeus Scientific, Inc.
Microbiology · 21d
Cleared May 27, 1981
CYCLIC AMP RADIOIMMUNOASSAY KIT [125I]
K811273 · CHO
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared May 27, 1981
PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT
K811274 · JFH
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared May 27, 1981
NOVA 5
K811289 · JGS
Nova Biomedical Corp.
Chemistry · 16d
Cleared May 27, 1981
CERVICAL SUPPORT
K811297 · IQF
Orthomedics
Physical Medicine · 16d
Cleared May 27, 1981
EXECUTIVE COLLAR
K811298 · IQK
Orthomedics
Physical Medicine · 16d
Cleared May 27, 1981
TUBMATE
K811301 · ILS
American Stair-Glide Corp.
Physical Medicine · 16d
Cleared May 27, 1981
LIQUID CHROMATOGRAPHY COLUMNS
K811304 · DPM
Supelco, Inc.
Toxicology · 16d
Cleared May 27, 1981
COAT-A-COUNT T4 RIA KIT
K811315 · CDX
Diagnostic Products Corp.
Chemistry · 16d
Cleared May 21, 1981
FLUID WARMER
K803249 · LGZ
Datachem, Inc.
General Hospital · 149d
Cleared May 21, 1981
ROLL-A-SET
K810918 · FRG
Principle Business Ent.
General Hospital · 45d