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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
193–216 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 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
Cleared Jun 05, 2015
FreeStyle Freedom Lite Blood Glucose Monitoring System
K150531 · NBW
Abbott Laboratories
Chemistry · 95d
Cleared Jun 05, 2015
FreeStyle Lite Blood Glucose Monitoring System
K150332 · NBW
Abbott Laboratories
Chemistry · 115d
Cleared May 22, 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654 · PDJ
Abbott Laboratories
Chemistry · 434d
Cleared May 06, 2015
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
K143434 · MSS
Abbott Medical Optics, Inc.
Ophthalmic · 156d
Cleared Apr 16, 2015
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total...
K133002 · DHA
Abbott Point of Care, Inc.
Chemistry · 569d
Cleared Apr 02, 2015
Total Bilirubin
K150510 · CIG
Abbott Laboratories
Chemistry · 34d