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

5,275 results for "health"
697–720 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 29, 2022
Next Generation NetKonnect
K220989 · MHX
Nihon Kohden Digital Health...
Cardiovascular · 116d
Cleared Jul 29, 2022
Deep Learning Image Reconstruction
K220961 · JAK
Ge Healthcare Japan Corporation
Radiology · 119d
Cleared Jul 27, 2022
OTC DDR
K221853 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 30d
Cleared Jul 18, 2022
Ultrasonic Scalpel System
K212614 · LFL
Surgnova Healthcare Technologies...
General & Plastic Surgery · 334d
Cleared Jul 16, 2022
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder...
K221229 · LZA
Zibo Blue Sail Health Technology Co.,...
General Hospital · 78d
Cleared Jul 15, 2022
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar,...
K220127 · OBP
Neuronetics, Inc.
Neurology · 178d
Cleared Jul 14, 2022
20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit...
K220258 · JKA
Avia Vascular
General Hospital · 164d
Cleared Jul 06, 2022
Lancet (I, II, III, V, VI)
K220475 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 138d
Cleared Jul 06, 2022
Disposable Coaxial Biopsy Needle
K212822 · FCG
Suzhou Leapmed Healthcare Corporation
General & Plastic Surgery · 306d
Cleared Jul 06, 2022
Disposable Semi Automatic Biopsy Instrument
K212820 · KNW
Suzhou Leapmed Healthcare Corporation
General & Plastic Surgery · 306d
Cleared Jul 06, 2022
Disposable Biopsy Refill Needle
K212819 · FCG
Suzhou Leapmed Healthcare Corporation
General & Plastic Surgery · 306d
Cleared Jul 06, 2022
Minuteful - kidney test
K210069 · JIR
Healthy.Io, Ltd.
Chemistry · 541d
Cleared Jul 05, 2022
SleepCheckRx
K213360 · MNR
Resapp Health
Anesthesiology · 266d
Cleared Jul 01, 2022
Prevena Restor Adapti-Form Dressing
K220660 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 116d
Cleared Jun 30, 2022
leva Pelvic Health System
K213913 · HIR
Renovia, Inc.
Gastroenterology & Urology · 197d
Cleared Jun 28, 2022
Magnum
K220670 · FXX
Magnum Health and Safety Pvt, Ltd.
General Hospital · 113d
Cleared Jun 23, 2022
Ultrasound System SONIMAGE MX1
K220993 · IYN
Konica Minolta, Inc.
Radiology · 80d
Cleared Jun 23, 2022
CoLumbo
K220497 · QIH
Smart Soft Healthcare AD
Radiology · 121d
Cleared Jun 22, 2022
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting...
K220413 · QPP
Canary Medical USA, LLC
Orthopedic · 128d
Cleared Jun 21, 2022
Syngo Carbon Space VA20A
K213665 · LLZ
Siemens Healthcare GmbH
Radiology · 211d
Cleared Jun 10, 2022
Surgical Isolation Cover Gown
K220528 · FYC
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 106d
Cleared Jun 09, 2022
MyCRO Band
K213587 · MVA
Otto Bock Healthcare LP
Neurology · 209d
Cleared Jun 08, 2022
AIR Recon DL
K213717 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 196d
Cleared Jun 06, 2022
Diacare 7000
K211207 · PBX
Globus Sport and Health Technologies,...
General & Plastic Surgery · 410d