FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
27097–27120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2017
Neuro Omega System
K171581 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 205d
Cleared Dec 22, 2017
B. Braun Tear-Away Introducer Needle
K171584 · BSO
B.Braun Medical, Inc.
Anesthesiology · 205d
Cleared Dec 22, 2017
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early...
K172257 · JHI
True Diagnostics, Inc.
Chemistry · 149d
Cleared Dec 22, 2017
Arthrosurface Bone Screws
K172383 · HWC
Arthrosurface, Inc.
Orthopedic · 136d
Cleared Dec 22, 2017
VPOD ITPR
K172388 · BWF
Advanced Circulatory System, A Wholly...
Anesthesiology · 136d
Cleared Dec 22, 2017
SOZO
K172507 · DSB
ImpediMed Limited
Cardiovascular · 126d
Cleared Dec 22, 2017
Align Radial Head System
K172688 · KWI
Skeletal Dynamics, LLC
Orthopedic · 107d
Cleared Dec 22, 2017
GammaPod - Model A
K172706 · IWB
Xcision Medical Systems, LLC
Radiology · 106d
Cleared Dec 22, 2017
CONQUEST FN
K172785 · JDO
Smith & Nephew
Orthopedic · 98d
Cleared Dec 22, 2017
SurgeoBite
K172978 · JXL
Surgovations, LLC
Neurology · 86d
Cleared CT Dec 22, 2017
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
K173492 · OYX
MolecularMD Corporation
Pathology · 39d
Cleared Dec 21, 2017
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294,...
K170005 · MXZ
Dako Denmark A/S
Pathology · 352d
Cleared Dec 21, 2017
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako...
K170028 · MYA
Dako Denmark A/S
Pathology · 352d
Cleared Dec 21, 2017
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated...
K171043 · EYB
Coloplast Corp.
Gastroenterology & Urology · 258d
Cleared Dec 21, 2017
Ives MR Conditional Cup Electrode
K171102 · GXY
Ives Egg Solutions
Neurology · 252d
Cleared Dec 21, 2017
Praxiject 0.9% NaCl
K171109 · NGT
Medxl, Inc.
General Hospital · 251d
Cleared Dec 21, 2017
ROCCIA® MultiLIF
K171434 · MAX
Silony Medical GmbH
Orthopedic · 220d
Cleared Dec 21, 2017
Deltaven XiV Max, Deltaven XiV Max FF
K171530 · FOZ
Delta Med Spa
General Hospital · 210d
Cleared Dec 21, 2017
FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers,...
K171848 · MAX
Globus Medical, Inc.
Orthopedic · 183d
Cleared Dec 21, 2017
SLM-1ER, SLM-2ER, SLM-3ER
K171877 · HJO
Chongqing Kanghua Ruiming S&T Co., Ltd.
Ophthalmic · 181d
Cleared Dec 21, 2017
Sofia Strep A+ FIA, Sofia 2 Analyzer
K171976 · GTY
Quidel Corporation
Microbiology · 174d
Cleared Dec 21, 2017
Tyber Medical PT Interbody Spacer System
K172185 · ODP
Tyber Medical, LLC
Orthopedic · 154d
Cleared Dec 21, 2017
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination...
K172321 · MQF
Cook Incorporated
Obstetrics & Gynecology · 142d
Cleared Dec 21, 2017
Blustone Synergy Silica System
K172330 · MQP
Blustone Synergy
Orthopedic · 141d