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"
1009–1032 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 14, 2020
Xelis Dental 2.0
K193369 · LLZ
Infinitt Healthcare Co., Ltd.
Radiology · 131d
Cleared Apr 14, 2020
KY Grosz UltraGel
K192982 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 172d
Cleared Apr 13, 2020
ADVIA Centaur CEA Assay
K200215 · DHX
Siemens Healthcare Disgnostics, Inc.
Immunology · 76d
Cleared Apr 10, 2020
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI...
K193573 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 109d
Cleared Apr 10, 2020
SIGNA Premier
K193282 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 135d
Cleared Apr 06, 2020
ADVIA Centaur CA 125II
K200199 · LTK
Siemens Healthcare Diagnostics, Inc.
Immunology · 70d
Cleared Mar 29, 2020
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE...
K200494 · MHX
Ge Healthcare
Cardiovascular · 30d
Cleared Mar 29, 2020
Torc Body
K192039 · NGX
Johari Digital Healthcare Limited
Physical Medicine · 243d
Cleared Mar 27, 2020
uMR Omega
K193200 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared Mar 27, 2020
RAPIDPoint 500e Blood Gas System
K192240 · CHL
Siemens Healthcare Diagnostics, Inc.
Chemistry · 221d
Cleared Mar 20, 2020
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health...
K193327 · FYA
Cardinal Health200, LLC
General Hospital · 109d
Cleared Mar 20, 2020
EnlightenVue Microendoscopy System
K192300 · GCJ
Enlightenvue, Inc.
General & Plastic Surgery · 210d
Cleared Mar 19, 2020
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
K191818 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 258d
Cleared Mar 14, 2020
Health Expert Electronic Stimulator (model: AST-300L)
K190783 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 353d
Cleared Mar 13, 2020
PrisMax System Version 3
K193482 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 87d
Cleared Mar 13, 2020
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
K193110 · QKM
3M Healthcare
General Hospital · 122d
Cleared Mar 13, 2020
Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential...
K191869 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 245d
Cleared Mar 12, 2020
Health Line CT Midline Catheter
K200263 · FOZ
Health Line International Corporation
General Hospital · 38d
Cleared Mar 09, 2020
F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve...
K191624 · MNT
Fisher & Paykel Healthcare Limited
Anesthesiology · 265d
Cleared Mar 05, 2020
Kinepict Medical Imaging Tool version v2.2
K190993 · LLZ
Kinepict Health, Ltd.
Radiology · 324d
Cleared Feb 25, 2020
uCT 530, uCT 550
K200016 · JAK
Shanghai United Imaging Healthcare...
Radiology · 53d
Cleared Feb 21, 2020
OASIS MRI System
K192851 · LNH
Hitachi Healthcare Americas
Radiology · 141d
Cleared Feb 19, 2020
D R Burton OxyPAP
K192000 · BWF
D R Burton Healthcare, LLC
Anesthesiology · 208d
Cleared Feb 18, 2020
Collaboration Live
K200179 · LLZ
Philips Health Care
Radiology · 25d