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"
1249–1272 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 24, 2018
Portable ECG Monitor (ECG3)
K172862 · DSH
Andon Health Co, Ltd.
Cardiovascular · 307d
Cleared Jul 20, 2018
JGH1 Core Deccompression Procedure Kit
K181585 · MQV
AgNovos Healthcare USA, LLC
Orthopedic · 35d
Cleared Jul 19, 2018
JGH1 Bone Graft Substitute
K181342 · MQV
AgNovos Healthcare USA, LLC
Orthopedic · 59d
Cleared Jul 19, 2018
Latitud Hip Replacement System
K172857 · LPH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 302d
Cleared Jul 19, 2018
Atellica IM High-Sensitivity Troponin I (TNIH)
K171566 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 415d
Cleared Jul 18, 2018
ARIETTA 65
K181376 · IYN
Hitachi Healthcare Americas Corporation
Radiology · 55d
Cleared Jul 18, 2018
DIP/U.S. Urine Analysis Test System
K173327 · JIL
Healthy.Io, Ltd.
Chemistry · 271d
Cleared Jul 18, 2018
Capnograph and Oximeter
K170820 · CCK
Cmi Health, Inc.
Anesthesiology · 485d
Cleared Jul 16, 2018
Atellica IM BRAHMS Procalcitonin (PCT)
K181002 · PMT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 91d
Cleared Jul 13, 2018
Dimension Hemoglobin A1c Assay
K173909 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 203d
Cleared Jul 13, 2018
Sterile Latex Surgical Gloves, Powder Free
K171550 · KGO
Sanrea Healthcare Products Pvt, Ltd.
General Hospital · 413d
Cleared Jul 12, 2018
ADVIA Centaur High-Sensitivity Troponin I (TNIH)
K171274 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 437d
Cleared Jun 27, 2018
uDR 592h, uDR 596i
K181413 · KPR
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared Jun 27, 2018
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with...
K180646 · LZC
Halyard Health
General Hospital · 107d
Cleared Jun 22, 2018
OSOM Mono Test
K181436 · KTN
SEKISUI Diagnostics, LLC
Microbiology · 21d
Cleared Jun 21, 2018
Eclipse II
K180809 · MQB
Carestream Health, Inc.
Radiology · 85d
Cleared Jun 21, 2018
BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
K173028 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 266d
Cleared Jun 19, 2018
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
K180710 · NLH
Innovative Health, LLC
Cardiovascular · 92d
Cleared Jun 18, 2018
AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816,...
K172895 · DXN
Ageless Health Industrial Co., Ltd.
Cardiovascular · 269d
Cleared Jun 15, 2018
Fusion Bx 2.0
K181290 · LLZ
Focal Healthcare, Inc.
Radiology · 30d
Cleared Jun 15, 2018
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
K173507 · LNH
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 214d
Cleared Jun 14, 2018
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent...
K180738 · EZD
Compactcath, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 13, 2018
HealthCCS
K172983 · JAK
Zebra Medical Vision, Ltd.
Radiology · 259d
Not Cleared Jun 12, 2018
DreaMed Advisor Pro
DEN170043 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 299d