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"
1225–1248 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 25, 2018
5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag...
K181692 · NEU
Health Beacons, Inc.
General & Plastic Surgery · 90d
Cleared Sep 24, 2018
Probe Covers for Thermometers
K180714 · FLL
K-Jump Health Co., Ltd.
General Hospital · 189d
Cleared Sep 21, 2018
Volpara Imaging Software
K182310 · LLZ
Volpara Health Technologies Limited
Radiology · 28d
Cleared Sep 21, 2018
Pocket Colposcope System
K181034 · HEX
Hadleigh Health Technologies, LLC
Obstetrics & Gynecology · 156d
Cleared Sep 20, 2018
LOGIQ P9
K181783 · IYN
Ge Healthcare
Radiology · 79d
Cleared Sep 19, 2018
Oh'Care Lite Smart Blood Glucose Monitoring System
K182286 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 27d
Cleared Sep 07, 2018
syngo.via View&GO (Version VA10A)
K182208 · LLZ
Siemens Healthcare GmbH
Radiology · 23d
Cleared Sep 07, 2018
INNOVANCE Free PS Ag
K181525 · GGP
Siemens Healthcare Diagnostics...
Hematology · 88d
Cleared Aug 31, 2018
ALTAPORE
K181225 · MQV
Baxter Healthcare Corporation
Orthopedic · 115d
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