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"
577–600 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 09, 2023
Latitud™ Hip Replacement System
K222436 · LPH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 270d
Cleared May 04, 2023
Orchid Safety Release Valve
K230266 · QOI
Linear Health Sciences, LLC
General Hospital · 93d
Cleared Apr 28, 2023
BNLE Access Guidewire
K221390 · DQX
Biomerics Nle
Cardiovascular · 350d
Cleared Apr 27, 2023
Precision DL
K223212 · KPS
Ge Healthcare
Radiology · 192d
Cleared Apr 27, 2023
Myolift QT
K213078 · NFO
Johari Digital Healthcare Limited
Physical Medicine · 581d
Cleared Apr 25, 2023
Konicaminolta DI-X1
K230906 · LLZ
Konica Minolta, Inc.
Radiology · 25d
Cleared Apr 25, 2023
MiVu™ Esophageal Endo Cap
K230056 · QIS
Diversatek Healthcare
Gastroenterology & Urology · 106d
Cleared Apr 24, 2023
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core...
K230140 · MWP
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Apr 24, 2023
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
K230136 · MWP
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Apr 20, 2023
Deep Learning Image Reconstruction
K230807 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Apr 19, 2023
TAP Lancet
K223201 · FMK
Yourbio Health, Inc.
General & Plastic Surgery · 187d
Not Cleared Apr 17, 2023
NTX100 Tonic Motor Activation (NTX100 ToMAc) System
DEN220059 · QWD
Noctrix Health, Inc.
Neurology · 208d
Cleared Apr 06, 2023
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19,...
K223531 · MHX
GE Healthcare Finland Oy
Cardiovascular · 134d
Cleared Apr 06, 2023
F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
K222197 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 258d
Cleared Apr 04, 2023
Reprocessed NRG Transseptal Needle
K213584 · QLZ
Innovative Health, LLC
Cardiovascular · 508d
Cleared Apr 03, 2023
Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall...
K230028 · JOW
Cardinal Health200, LLC
Cardiovascular · 89d
Cleared Mar 31, 2023
Spectrum IQ Infusion System with Dose IQ Safety Software
K230041 · FRN
Baxter Healthcare Corporation
General Hospital · 84d
Cleared Mar 31, 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · FRN
Baxter Healthcare Corporation
General Hospital · 86d
Cleared Mar 28, 2023
Gas Insufflator
K221995 · HIF
Surgnova Healthcare Technologies...
Obstetrics & Gynecology · 265d
Cleared Mar 24, 2023
SmartMTA Capsule
K230797 · KIF
Sprig Oral Health Technologies, Inc.
Dental · 2d
Cleared Mar 24, 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for...
K230002 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 80d
Cleared Mar 24, 2023
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting...
K223803 · QPP
Canary Medical USA, LLC
Orthopedic · 95d
Cleared Mar 23, 2023
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice...
K221585 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 295d
Cleared Mar 22, 2023
Stativ® Knotted UHMWPE Suture Anchor
K223889 · MBI
Healthium Medtech Limited
Orthopedic · 85d