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"
1465–1488 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 31, 2016
Unger Quad Injector
K161483 · LCJ
Stradis Healthcare
General & Plastic Surgery · 153d
Cleared Oct 28, 2016
Gammex Cut-Resistant Glove Liner
K160974 · KGO
Ansell Healthcare Products, LLC
General Hospital · 204d
Cleared Oct 28, 2016
ClearVision ExamVue Flat Panel Detector
K160143 · MQB
Jpi Healthcare, Inc.
Radiology · 281d
Cleared Oct 28, 2016
Xonrid Gel
K152533 · FRO
Helsinn Healthcare SA
General & Plastic Surgery · 421d
Cleared Oct 26, 2016
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
K161393 · NLH
Innovative Health, LLC
Cardiovascular · 160d
Cleared Oct 19, 2016
Avance Tubing, Avance Y-Connector, Avance ViewPad
K161797 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 111d
Cleared Oct 13, 2016
ADVIA Centaur HAV IgM Assay
K161964 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 87d
Cleared Oct 03, 2016
Lumify Ultrasound System
K162549 · IYN
Philips Health Care
Radiology · 20d
Cleared Oct 03, 2016
Voluson E6, Voluson E8, Voluson E10
K162269 · IYN
Ge Healthcare
Radiology · 52d
Cleared Sep 30, 2016
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
K161464 · NLH
Innovative Health, LLC
Cardiovascular · 127d
Cleared Sep 30, 2016
ON-Q* EchoSpark Echogenic Catheter
K161232 · BSO
Halyard Health
Anesthesiology · 151d
Cleared Sep 30, 2016
Xprecia Stride Coagulation System, Xprecia System PT Controls
K151964 · GJS
Siemens Healthcare Diagnostics
Hematology · 442d
Cleared Sep 22, 2016
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging...
K161368 · MQB
Agfa Healthcare N.V.
Radiology · 128d
Cleared Sep 21, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K162338 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Sep 20, 2016
F&P Eson 2 Nasal Mask
K153505 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 288d
Cleared Sep 15, 2016
CORGRIP NG/NI Tube Retention System
K162110 · KNT
Corpak Medsystems, Inc. A Division of...
Gastroenterology & Urology · 48d
Cleared Sep 15, 2016
CARESCAPE Central Station V2
K162012 · DXJ
Ge Healthcare
Cardiovascular · 56d
Cleared Sep 14, 2016
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
K162329 · IYN
Philips Health Care
Radiology · 26d
Cleared Sep 09, 2016
AMC Health VitalCaregiving System
K151839 · MWI
Amc Health
Cardiovascular · 431d
Cleared Sep 07, 2016
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3...
K160724 · CGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 175d
Cleared Sep 06, 2016
HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
K160709 · LZC
Halyard Health
General Hospital · 176d
Cleared Sep 02, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K161317 · JPA
Siemens Healthcare Diagnostics...
Hematology · 114d
Cleared Sep 01, 2016
SIGNA Voyager
K161567 · LNH
Ge Healthcare
Radiology · 86d
Cleared Sep 01, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K161312 · JPA
Siemens Healthcare Diagnostics...
Hematology · 114d