FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93265–93288 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1997
DTX-100 BONE DENSITOMETER
K963789 · KGI
Osteometer Meditech A/S
Radiology · 297d
Cleared Jul 14, 1997
N-ASSAY TIA C4 TEST KIT
K964297 · DBI
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964298 · CZW
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964299 · LKL
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964300 · DBI
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964301 · DAD
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA C1-INACTIVATOR TEST KIT
K965024 · DBA
Crestat Diagnostics, Inc.
Immunology · 209d
Cleared Jul 14, 1997
N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
K965100 · DEM
Crestat Diagnostics, Inc.
Immunology · 206d
Cleared Jul 14, 1997
CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER
K965128 · GEX
Cynosure, Inc.
General & Plastic Surgery · 203d
Cleared Jul 14, 1997
CHROMOPHARE
K965130 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 203d
Cleared Jul 14, 1997
ACS DIGITOXIN
K970546 · LFM
Chiron Diagnostics Corp.
Chemistry · 152d
Cleared Jul 14, 1997
MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR
K970763 · DQA
Medical Data Electronics
Anesthesiology · 133d
Cleared Jul 14, 1997
LATEX EXAMINATION GLOVES
K970770 · LYY
Oon Corp. Resources
General Hospital · 133d
Cleared Jul 14, 1997
TARGOBEAM
K970819 · JAK
Ferguson Medical
Radiology · 131d
Cleared Jul 14, 1997
FG INFUSION CATHETER
K971306 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 97d
Cleared Jul 14, 1997
SUNGLASSES
K971385 · HQY
Kosway Industries Co., Ltd.
Ophthalmic · 91d
Cleared Jul 14, 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K971393 · LJZ
Immunoprobe, Inc.
Microbiology · 96d
Cleared Jul 14, 1997
GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN...
K971395 · DQX
Target Therapeutics
Neurology · 90d
Cleared Jul 14, 1997
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
K971474 · DTE
Medtronic Vascular
Cardiovascular · 82d
Cleared Jul 14, 1997
MENTOR GEMINI HEMOSTATIC ERASER
K971538 · HQO
Mentor Ophthalmics, Inc.
Ophthalmic · 77d
Cleared Jul 14, 1997
PROVEST-PROTECTIVE RESTRAINT
K971561 · FMQ
Jemm Medical Products
General Hospital · 76d
Cleared Jul 14, 1997
CREATINE KINASE-MB REAGENT SET
K971566 · CGS
Horizon Diagnostics, Inc.
Chemistry · 76d
Cleared Jul 14, 1997
VISTA BRITE TIP CATHETERS
K971572 · DQY
Cordis Corp.
Cardiovascular · 75d
Cleared Jul 14, 1997
ALCON CONTACT LENS CASE
K971618 · LRX
Alcon Laboratories
Ophthalmic · 73d