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"
1273–1296 of 5,277
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 29, 2018
Change Healthcare Enterprise Viewer
K181185 · LLZ
Change Healthcare Canada Company
Radiology · 118d
Cleared Aug 28, 2018
Tenex Health TX System with the TXP MicroTip
K181367 · LFL
Tenex Health, Inc.
General & Plastic Surgery · 97d
Cleared Aug 23, 2018
Freespira
K180173 · HCC
Palo Alto Health Sciences, Inc.
Neurology · 213d
Cleared Aug 22, 2018
Non-invasive blood pressure measurement systems
K173024 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 328d
Cleared Aug 17, 2018
Actifuse Flow
K181306 · MQV
Baxter Healthcare Corporation
Orthopedic · 92d
Cleared Aug 17, 2018
Optical Topography System ETG-4100
K172492 · DQA
Hitachi Healthcare Americas
Neurology · 365d
Cleared Aug 16, 2018
Bongo
K180619 · OHP
Innomed Healthscience, Inc.
Ear, Nose, Throat · 160d
Cleared Aug 15, 2018
Mini Ridge Filter and auxiliary functions for PROBEAT-V
K181676 · LHN
Hitachi Ltd. Healthcare Hitachi Works
Radiology · 51d
Cleared Aug 14, 2018
uCT 530, uCT 550
K181414 · JAK
Shanghai United Imaging Healthcare...
Radiology · 76d
Cleared Aug 08, 2018
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F &...
K181836 · DQO
Cordis, A Cardinal Health Company
Cardiovascular · 29d
Cleared Aug 08, 2018
F&P SleepStyle
K173193 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 310d
Cleared Aug 08, 2018
Ageless Health Medical Digital Thermometer
K172508 · FLL
Ageless Health Industrial Co., Ltd.
General Hospital · 352d
Cleared Jul 31, 2018
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with...
K180874 · FXX
3M Healthcare
General Hospital · 119d
Cleared Jul 30, 2018
Epiphany Cardio Server Mobile
K181720 · DQK
Epiphany Healthcare, LLC
Cardiovascular · 31d
Cleared Jul 30, 2018
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
K181213 · LFZ
Siemens Healthcare Diagnostics, Inc.
Microbiology · 84d
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