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:
1,305 results for "abbott"
193–216 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 18, 2017
QUANTIEN Measurement System
K172182 · DQK
St. Jude Medical (Now Part of the...
Cardiovascular · 30d
Cleared May 19, 2017
Catalys Precision Laser System
K170322 · OOE
Abbott Medical Optics, Inc.
Ophthalmic · 107d
Cleared Apr 10, 2017
i-Stat Alinity System with i-Stat Glucose test
K163271 · CGA
Abbott Point of Care, Inc.
Chemistry · 140d
Cleared Feb 28, 2017
FIRMap Catheter
K163709 · MTD
Abbott Electrophysiology
Cardiovascular · 60d
Cleared Feb 15, 2017
Abbott ARCHITECT Free T3
K170160 · JIT
Abbott Laboratories
Chemistry · 28d
Cleared Aug 12, 2016
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators,...
K153375 · MRG
Abbott Laboratories
Chemistry · 263d
Cleared Aug 10, 2016
Rhythm View Workstation (non-streaming)
K161240 · DQK
Abbott Electrophysiology
Cardiovascular · 100d
Cleared Aug 07, 2016
Steerable Guide Catheter
K161985 · DRA
Abbott Vascular
Cardiovascular · 19d
Cleared Jul 08, 2016
i-STAT Alinity System with i-STAT Sodium test
K153357 · JGS
Abbott Point of Care, Inc.
Chemistry · 231d
Cleared Jun 15, 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT...
K153730 · LIP
Abbott Laboratories
Microbiology · 170d
Cleared Apr 27, 2016
Dual Pump Pack
K160236 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 86d
Cleared Apr 07, 2016
FIRMap Catheter
K153093 · MTD
Abbott Electrophysiology
Cardiovascular · 164d
Cleared Feb 19, 2016
FreeStyle Precision Neo H Blood Glucose Monitoring System
K153330 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 92d
Cleared Dec 17, 2015
Freestyle Freedom Blood Glucose Monitoring Sytem
K152442 · NBW
Abbott Laboratories
Chemistry · 112d
Cleared Dec 17, 2015
ARCHITECT 2nd Generation Testosterone
K152155 · CDZ
Abbott Laboratories
Chemistry · 136d
Cleared Nov 20, 2015
RX ACCUNET Embolic Protection System
K153086 · NTE
Abbott Vascular
Cardiovascular · 25d
Cleared Oct 21, 2015
HI-TORQUE BALANCE
K152709 · DQX
Abbott Vascular
Cardiovascular · 30d
Cleared Oct 19, 2015
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature...
K151636 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 124d
Cleared Sep 30, 2015
FreeStyle Precision Neo Blood Glucose Monitoring System
K142928 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 356d
Cleared Sep 21, 2015
Hi-Torque Command 18 Guide Wire
K152404 · DQX
Abbott Vascular
Cardiovascular · 27d
Cleared Sep 17, 2015
FreeStyle InsuLinx Blood Glucose Monotioring System
K152328 · LFR
Abott Laboratories
Chemistry · 30d
Cleared Sep 02, 2015
COMPACT INTUITIV Multiple-Use Pack
K151783 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 63d
Cleared Jul 10, 2015
Abbott ARCHITECT Total T4 Calibrators
K151566 · JIT
Abbott Laboratories
Chemistry · 30d
Cleared Jul 06, 2015
Armada 18 PTA Catheter
K151317 · LIT
Abbott Vascular
Cardiovascular · 49d