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"
1393–1416 of 5,277
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 29, 2017
Voluson E6, Voluson E8, Voluson E10
K172342 · IYN
Ge Healthcare
Radiology · 58d
Cleared Sep 28, 2017
Digital Thermometer
K170262 · FLL
K-Jump Health Co., Ltd.
General Hospital · 244d
Cleared Sep 27, 2017
Peerbridge Cor(TM) System
K171936 · DSH
Peerbridge Health, Inc.
Cardiovascular · 91d
Cleared Sep 22, 2017
IV Fat Emulsion Administration Sets
K172544 · FPA
Baxter Healthcare Corporation
General Hospital · 30d
Cleared Sep 22, 2017
Occlusion Detection Dressing Kit
K171499 · OMP
Cardinalhealth
General & Plastic Surgery · 122d
Cleared Sep 19, 2017
Digital Thermometer
K163518 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 278d
Cleared Sep 18, 2017
Health-e-Connect System with IDA
K163664 · NDC
Alr Technologies
General Hospital · 265d
Cleared Sep 15, 2017
WowGoHealth Blood Glucose Monitoring System
K171785 · NBW
Biotest Medical Corporation
Chemistry · 92d
Cleared Sep 15, 2017
iHealth Align Gluco-Monitoring System (BG1)
K170231 · NBW
Andon Health Co, Ltd.
Chemistry · 233d
Cleared Sep 14, 2017
Clarius Ultrasound System
K172385 · IYN
Clarius Mobile Health Corp.
Radiology · 37d
Cleared Sep 09, 2017
All-in-One Health Monitor, PC-303
K170047 · MWI
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 247d
Cleared Sep 01, 2017
Senographe Pristina
K163302 · MUE
Ge Healthcare
Radiology · 283d
Cleared Aug 31, 2017
Atellica IM Ferritin Assay
K171642 · DBF
Siemens Healthcare Diagnostics, Inc.
Immunology · 90d
Cleared Aug 25, 2017
Hexagen Derm
K171191 · FRO
Global Health Solutions, LLC
General & Plastic Surgery · 123d
Cleared Aug 24, 2017
Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve -...
K170367 · MNT
Fisher and Paykel Healthcare Limited
Anesthesiology · 199d
Cleared Aug 22, 2017
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r)...
K162540 · KFF
Siemens Healthcare Diagnostics...
Hematology · 344d
Cleared Aug 18, 2017
Supria True64
K171738 · JAK
Hitachi Healthcare Americas Corporation
Radiology · 67d
Cleared Aug 18, 2017
Optum TeleHealth Application
K171406 · DRG
United Health Group, Inc.
Cardiovascular · 98d
Cleared Aug 17, 2017
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
K171028 · CCK
GE Healthcare Finland Oy
Anesthesiology · 134d
Cleared Aug 16, 2017
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
K172162 · IYN
Siemens Healthcare
Radiology · 29d
Cleared Aug 11, 2017
ADVIA 2120i, ADVIA 2120
K162977 · GKZ
Siemens Healthcare Diagnostics
Hematology · 289d
Cleared Aug 10, 2017
3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models...
K171116 · MSH
3M Healthcare
General Hospital · 118d
Cleared Aug 02, 2017
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
K171172 · MOL
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 103d
Cleared Aug 02, 2017
Hearing Healthcare Pro
K171038 · ETY
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 118d