FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
1321–1344 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 29, 2017
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
K171737 · LZA
Ansell Healthcare Products, LLC
General Hospital · 200d
Cleared Dec 26, 2017
Real Time Image Gating System for Proton Beam Therapy Systems
K171049 · LHN
Hitachi, Ltd. Healthcare
Radiology · 263d
Cleared Dec 20, 2017
LOGIQ E10
K173555 · IYN
Ge Healthcare
Radiology · 33d
Cleared Dec 20, 2017
Electric Breast Pump
K172989 · HGX
Joytech Healthcare Co. , Ltd.
Obstetrics & Gynecology · 84d
Cleared Dec 19, 2017
Digital thermometer(with disposable thermometer cover)
K172861 · FLL
Hangzhou Hua'An Medical&Health...
General Hospital · 90d
Cleared Dec 18, 2017
Automated Blood Coagulation Analyzer CS-2500
K172286 · JPA
Siemens Healthcare Diagnostic...
Hematology · 143d
Cleared Dec 08, 2017
Merge PACS
K173475 · LLZ
Merge Healthcare Incorporated
Radiology · 29d
Cleared Dec 04, 2017
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
K171771 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 173d
Cleared Nov 30, 2017
Destiknee™ Total Knee System
K172936 · JWH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 65d
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