Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
139057–139080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1987
MICRO MAMMO I MAMMOGRAPHY UNIT
K871048 · IZH
Amerasia Import-Export, Inc.
Radiology · 168d
Cleared Sep 01, 1987
HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT
K871349 · JWH
Howmedica Corp.
Orthopedic · 148d
Cleared Sep 01, 1987
HOLTER ST SYSTEM, MODEL NO. 5000-20
K871389 · DSI
Holter Data Services
Cardiovascular · 147d
Cleared Sep 01, 1987
THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS
K872085 · LSW
Immunodiagnostics, Ltd.
Immunology · 92d
Cleared Sep 01, 1987
CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500
K872167 · DTP
American Bentley
Cardiovascular · 85d
Cleared Sep 01, 1987
ADJUSTABLE PEEP VALVE
K872202 · BYE
Med Air Technology, Inc.
Anesthesiology · 85d
Cleared Sep 01, 1987
DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM
K872455 · LLZ
Adac Laboratories
Radiology · 70d
Cleared Sep 01, 1987
BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT)
K872705 · GEI
Clinical Technology Corp.
General & Plastic Surgery · 56d
Cleared Sep 01, 1987
KARYOTEC 100
K872755 · LNJ
Amcor Electronics, Ltd.
Pathology · 50d
Cleared Sep 01, 1987
TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS
K873005 · HRS
Techmedica, Inc.
Orthopedic · 28d
Cleared Aug 31, 1987
GENE-TRAK CAMPYLOBACTER ASSAY
K863270 · LQO
Integrated Genetics
Microbiology · 371d
Cleared Aug 31, 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117 · CGA
Biotrol, USA, Inc.
Chemistry · 21d
Cleared Aug 28, 1987
IQ DIGOXIN
K864223 · KXT
Bd Becton Dickinson Vacutainer...
Toxicology · 304d
Cleared Aug 28, 1987
ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER
K864849 · JJE
Antek Instruments, Inc.
Chemistry · 261d
Cleared Aug 28, 1987
CAVROPUMP
K871129 · DXT
Life-Tech Intl., Inc.
Gastroenterology & Urology · 161d
Cleared Aug 28, 1987
ANNULAR ARRAY SCANHEAD
K871856 · HGL
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 108d
Cleared Aug 28, 1987
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K872107 · DTZ
Minntech Corp.
Cardiovascular · 80d
Cleared Aug 28, 1987
CURAD MEDICATED PLASTIC STRIPS
K872310 · CGX
The Kendal Co.
Chemistry · 74d
Cleared Aug 28, 1987
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93
K872321 · DKJ
Em Diagnostic Systems, Inc.
Chemistry · 72d
Cleared Aug 28, 1987
CEDIA DIGOXIN CR ASSAY
K872583 · KXT
Microgenics Corp.
Chemistry · 59d
Cleared Aug 28, 1987
ULTRASCAN IGE ASSAY KIT
K872968 · DGC
Specialty Medical Industries, Inc.
Immunology · 30d
Cleared Aug 28, 1987
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
K873049 · CDT
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Aug 28, 1987
TECHNICON H*1 JR.(TM) SYSTEM
K873103 · GKL
Technicon Instruments Corp.
Hematology · 21d
Cleared Aug 28, 1987
MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET
K873109 · OJA
Life-Tech Intl., Inc.
Gastroenterology & Urology · 21d