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"
1153–1176 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 05, 2019
OJR215 Pressure Relief Manifold
K173770 · CBP
Fisher & Paykel Healthcare Limited
Anesthesiology · 480d
Cleared Apr 02, 2019
ARIETTA 50
K190248 · IYN
Hitachi Healthcare Americas
Radiology · 54d
Cleared Mar 29, 2019
Loop System
K181352 · DQA
Spry Health, Inc.
Cardiovascular · 311d
Cleared Mar 27, 2019
Wearable Device, Home Package in Carry Case with Homehub, Home Package in...
K190073 · MSX
Current Health , Ltd.
Cardiovascular · 70d
Cleared Mar 25, 2019
InTouch Thermal Camera
K181716 · LHQ
Intouch Technologies, Inc., D.B.A....
Radiology · 270d
Cleared Mar 22, 2019
uWS-MR
K183164 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 127d
Cleared Mar 22, 2019
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
K182948 · KGO
Ansell Healthcare Products, LLC
General Hospital · 150d
Cleared Mar 22, 2019
ON-Q* Pump with Bolus
K181360 · MEB
Halyard Health
General Hospital · 304d
Cleared Mar 20, 2019
ACUSON S3000, S2000 Diagnostic Ultrasound System
K183575 · IYN
Siemens Healthineers
Radiology · 89d
Cleared Mar 14, 2019
Omron Model BP7900 Blood Pressure Monitor + EKG
K182579 · DXN
Omron Healthcare, Inc.
Cardiovascular · 176d
Cleared Mar 07, 2019
DARI Health
K180880 · LXJ
Scientific Analytics, Inc.
Physical Medicine · 338d
Cleared Mar 06, 2019
Hearing Healthcare Pro
K183201 · ETY
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 107d
Cleared Mar 04, 2019
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
K182225 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 200d
Cleared Feb 28, 2019
Digital Thermometer
K182629 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 157d
Cleared Feb 27, 2019
uPMR 790
K183014 · OUO
Shanghai United Imaging Healthcare...
Radiology · 119d
Cleared Feb 22, 2019
Reprocessed Response Diagnostic Electrophysiology Catheter
K182488 · NLH
Innovative Health, LLC
Cardiovascular · 164d
Cleared Feb 21, 2019
Sensus Healthcare TVM Balloon Applicator
K190255 · JAD
Sensus Healthcare, Inc.
Radiology · 14d
Cleared Feb 21, 2019
Sensus TPS Workstation
K182665 · MUJ
Sensus Healthcare, Inc.
Radiology · 149d
Cleared Feb 21, 2019
Sensus IORT System
K182641 · JAD
Sensus Healthcare, Inc.
Radiology · 150d
Cleared Feb 15, 2019
IPL Hair Removal Device
K183217 · OHT
Touchbeauty Beauty & Health...
General & Plastic Surgery · 88d
Cleared Feb 14, 2019
Presero 3D Scanning System
K190074 · LLZ
Certis Health
General & Plastic Surgery · 29d
Cleared Feb 08, 2019
Carestream DRX-1 System with DRX Plus 2530 Detectors
K183245 · MQB
Carestream Health, Inc.
Radiology · 79d
Cleared Feb 08, 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint...
K183186 · MOS
Shanghai United Imaging Healthcare...
Radiology · 81d
Cleared Feb 01, 2019
Supria True64 Whole-Body X-Ray CT System
K183291 · JAK
Hitachi Healthcare Americas
Radiology · 67d