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"
649–672 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 30, 2022
Novum IQ Syringe Pump
K211125 · FRN
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 30, 2022
Dose IQ Safety Software
K211124 · PHC
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 26, 2022
Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
K220262 · PRI
Siemens Healthcare Diagnostics, Inc.
Microbiology · 207d
Cleared Aug 24, 2022
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System,...
K222230 · OBP
Neuronetics, Inc.
Neurology · 30d
Cleared Aug 19, 2022
FUJIFILM Ultrasonic Endoscope EG-740UT
K221238 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 112d
Cleared Aug 11, 2022
AI-Rad Companion (Pulmonary)
K213713 · JAK
Siemens Healthcare GmbH
Radiology · 260d
Cleared Aug 06, 2022
Reprocesses Umbilical Cable
K221854 · NLH
Innovative Health, LLC
Cardiovascular · 40d
Cleared Aug 04, 2022
Endoscope Model EG-580UT and Endoscope Model EG-580UR
K221952 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Aug 04, 2022
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
K220524 · NUH
Well-Life Healthcare Limited
Neurology · 162d
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