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"
769–792 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 10, 2021
Airvo Nebulizer Adapter
K211560 · CAF
Fisher & Paykel Healthcare Limited
Anesthesiology · 204d
Cleared Dec 10, 2021
EXA
K203743 · LLZ
Konica Minolta Healthcare Americas, Inc.
Radiology · 353d
Cleared Dec 04, 2021
Nitrile Powder Free Blue Examination Gloves, Non-Sterile
K212535 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 115d
Cleared Dec 01, 2021
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
K212864 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 84d
Cleared Nov 24, 2021
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · JFY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 131d
Cleared Nov 24, 2021
Non-Contact Infrared Thermometer, model HL710H
K211744 · FLL
Health & Life Co., Ltd.
General Hospital · 170d
Cleared Nov 24, 2021
Regulora
K211463 · QMY
Metame Health, Inc.
Gastroenterology & Urology · 197d
Cleared Nov 23, 2021
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub...
K211765 · FYA
Cardinal Health, LLC
General Hospital · 168d
Cleared Nov 23, 2021
PCEA Syringe Set
K211649 · PWH
Baxter Healthcare Corporation
General Hospital · 179d
Cleared Nov 22, 2021
Eclipse PRO
K211651 · MWJ
Spacelabs Healthcare, Ltd.
Cardiovascular · 178d
Cleared Nov 22, 2021
Philips Incisive CT on Trailer
K211168 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 217d
Cleared Nov 18, 2021
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
K211662 · NLG
Innovative Health, LLC
Cardiovascular · 170d
Cleared Nov 16, 2021
Opulent TiNbN Coated Knee
K212839 · JWH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 70d
Cleared Nov 15, 2021
Clarius Ultrasound Scanner
K213436 · IYN
Clarius Mobile Health Corp.
Radiology · 24d
Cleared Nov 10, 2021
Disposable Automatic Core Biopsy Instrument
K212284 · KNW
Suzhou Leapmed Healthcare Corporation
Gastroenterology & Urology · 112d
Cleared Nov 03, 2021
Nulife
K210969 · KGO
Mrk Healthcare Pvt, Ltd.
General Hospital · 217d
Cleared Oct 29, 2021
Balloon BS-3
K213195 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Oct 29, 2021
N Latex FLC kappa, N Latex FLC lambda
K201496 · DFH
Siemens Healthcare Diagnostics...
Immunology · 511d
Cleared Oct 29, 2021
Phoenix Digital Thermometer
K201032 · FLL
Phoenix Innovative Healthcare...
General Hospital · 557d
Cleared Oct 27, 2021
V.A.C.ULTA Negative Pressure Wound Therapy System
K203316 · OMP
Kci, A Part of 3M Health Care...
General & Plastic Surgery · 351d
Cleared Oct 25, 2021
Ultrasonic Surgical & Electrosurgical Generator
K210488 · GEI
Surgnova Healthcare Technologies...
General & Plastic Surgery · 248d
Cleared Oct 21, 2021
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
K211171 · CCK
GE Healthcare Finland Oy
Anesthesiology · 185d
Cleared Oct 20, 2021
iRAD
K212470 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 75d
Cleared Oct 19, 2021
U9000 Plus Ultrafilter
K211035 · FIP
Baxter Healthcare Corporation
Gastroenterology & Urology · 195d