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"
529–552 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 30, 2023
Sonic DL
K223523 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 188d
Cleared May 26, 2023
Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
K213289 · KGO
Ansell Healthcare Products, LLC
General Hospital · 602d
Cleared May 23, 2023
uMR Omega
K230152 · LNH
Shanghai United Imaging Healthcare...
Radiology · 124d
Cleared May 19, 2023
PrevisEA Device
K230769 · DQD
Entac Medical, Inc.
Gastroenterology & Urology · 60d
Cleared May 18, 2023
uMR 570
K230758 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared May 17, 2023
DeepX DermoSight Dermatoscope
K230448 · PSN
Deepx Health, LLC
General & Plastic Surgery · 85d
Cleared May 17, 2023
F&P Solo Mask Range
K223696 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 159d
Cleared May 15, 2023
Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro)
K202993 · PHW
Mmj Labs, LLC
Physical Medicine · 957d
Cleared May 11, 2023
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
K230280 · KTI
Ga Health Company Limited
Ear, Nose, Throat · 99d
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