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

5,277 results for "health"
1369–1392 of 5,277
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 22, 2017
AIR Anterior Array, AIR Posterior Array
K172695 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 76d
Cleared Nov 22, 2017
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
K170666 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 261d
Cleared Nov 21, 2017
3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial...
K170754 · FRO
3M Company, 3M Healthcare
General & Plastic Surgery · 253d
Cleared Nov 20, 2017
syngo®.via protoNeo (Version VA20)
K173378 · LLZ
Siemens Healthcare GmbH
Radiology · 21d
Cleared Nov 17, 2017
N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC...
K171742 · DFH
Siemens Healthcare Diagnostics...
Immunology · 158d
Cleared Nov 16, 2017
Merits Model R106/R136 Rehab Wheelchair
K170517 · IOR
Merits Healthcare Industries (Suzhou)...
Physical Medicine · 268d
Not Cleared Nov 15, 2017
NSS-2 System
DEN170018 · PZR
Innovative Health Solutions (Ihs), Inc.
Neurology · 243d
Cleared Nov 08, 2017
MHC Standard and NRFit Tip Syringes
K171131 · FMF
Mazza Healthcare, LLC
General Hospital · 205d
Cleared Nov 03, 2017
Reprocessed Halo XP Diagnostic Electrophysiology Catheter
K171788 · NLH
Innovative Health, LLC
Cardiovascular · 141d
Cleared Oct 31, 2017
Sysmex CS-5100
K172333 · JPA
Siemens Healthcare Diagnostics...
Hematology · 90d
Cleared Oct 31, 2017
ALOKA ARIETTA 850
K171708 · IYN
Hitachi Healthcare Americas Corporation
Radiology · 145d
Cleared Oct 30, 2017
SenoBright HD
K172404 · MUE
Ge Healthcare
Radiology · 82d
Cleared Oct 27, 2017
Infinitt PACS 7.0
K172803 · LLZ
Infinitt Healthcare Co., Ltd.
Radiology · 39d
Cleared Oct 25, 2017
Emit II Plus Cocaine Metabolite Assay
K170293 · DIO
Siemens Healthcare Diagnostics, Inc.
Toxicology · 267d
Cleared Oct 23, 2017
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K171277 · DRF
Innovative Health, LLC
Cardiovascular · 175d
Cleared Oct 19, 2017
Avail
K172079 · NUH
Omron Healthcare, Inc.
Neurology · 101d
Cleared Oct 18, 2017
Emit II Plus Oxycodone Assay
K172910 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 23d
Cleared Oct 18, 2017
OTC Combo TENS/EMS System
K172809 · NUH
Well-Life Healthcare Limited
Neurology · 30d
Cleared Oct 13, 2017
DX-D Imaging Package
K172784 · MQB
Agfa Healthcare N.V.
Radiology · 28d
Cleared Oct 13, 2017
Freemie Independence, Freemie Liberty
K172772 · HGX
Dao Health
Obstetrics & Gynecology · 29d
Cleared Oct 12, 2017
JUD custom fit condom
K172414 · HIS
Global Mailer Partners, LLC
Obstetrics & Gynecology · 63d
Cleared Oct 05, 2017
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
K171503 · NLH
Innovative Health, LLC
Cardiovascular · 135d
Cleared Oct 05, 2017
Gold AQ Blood Glucose Monitoring System
K170264 · NBW
Changsha Sinocare, Inc.
Chemistry · 251d
Cleared Oct 04, 2017
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound...
K172607 · IYN
Philips Health Care
Radiology · 35d