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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81913–81936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2000
ASCEND SPINAL FIXATION SYSTEM
K002069 · KWP
Spinal Innovations, LLC
Orthopedic · 90d
Cleared Oct 05, 2000
CATHCOR DESKTOP
K002137 · DQK
Siemens Elema AB
Cardiovascular · 83d
Cleared Oct 05, 2000
REFACTO LABORATORY STANDARD
K002350 · GGP
The Genetics Institute
Hematology · 64d
Cleared Oct 05, 2000
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
K002478 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 55d
Cleared Oct 05, 2000
XIA SPINE SYSTEM
K002505 · KWP
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Oct 05, 2000
RANDOX MICROALBUMIN
K002674 · DDZ
Randox Laboratories, Ltd.
Chemistry · 38d
Cleared Oct 05, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K002751 · DQA
Masimo Corp.
Anesthesiology · 30d
Cleared Oct 05, 2000
ELECSYS DHEA-S CALSET
K002760 · JIS
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Oct 05, 2000
VACUETTE WITH PPACK
K002777 · JKA
Greiner Vacuette North America, Inc.
Chemistry · 29d
Cleared Oct 05, 2000
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
K002799 · CFF
Beckman Coulter, Inc.
Chemistry · 27d
Cleared Oct 05, 2000
RAPID EXCHANGE TAPERTOME
K002802 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Oct 05, 2000
N PROTEIN STANDARD SL
K002804 · JIX
Dade Behring, Inc.
Chemistry · 27d
Cleared Oct 05, 2000
MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
K002850 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 22d
Cleared Oct 05, 2000
ELS CANNULA (KIT), MODEL M1210-88,M1510-88
K002857 · DWF
Jostra AG
Cardiovascular · 22d
Cleared Oct 05, 2000
MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K002879 · JEY
Bioplate, Inc.
Dental · 20d
Cleared Oct 04, 2000
GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
K001125 · NCE
Geuder GmbH
Ophthalmic · 180d
Cleared Oct 04, 2000
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460 · LYR
bioMerieux, Inc.
Microbiology · 147d
Cleared Oct 04, 2000
BROOKER TIBIA NAILS
K002057 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared Oct 04, 2000
AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES
K002074 · DPS
H&C Medical Devices Spa
Cardiovascular · 86d
Cleared Oct 04, 2000
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 69d
Cleared Oct 04, 2000
EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
K002484 · JDX
Electro Medical Systems SA
Orthopedic · 51d
Cleared Oct 04, 2000
ASCENT XXL CLOSED BOX FEMORAL COMPONENT
K002772 · JWH
Biomet, Inc.
Orthopedic · 28d
Cleared Oct 04, 2000
PRESSURE WIRE SENSOR, MODEL 12003/12303
K002962 · DQX
Radi Medical Systems AB
Cardiovascular · 12d
Cleared Oct 03, 2000
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
K001703 · GAW
Abbott Vascular, Inc.
General & Plastic Surgery · 120d