FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
7441–7464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2024
Momcozy Wearable Breast Pump (BP137)
K233880 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 89d
Cleared Mar 06, 2024
Insulin Syringe
K233794 · FMF
Spm Medicare Pvt. , Ltd.
General Hospital · 99d
Cleared Mar 06, 2024
Autofuse
K233572 · LLZ
Pymedix
Radiology · 121d
Cleared Mar 06, 2024
“BioGend” Interbody Fusion System 001 Cage
K233075 · MAX
Biogend Therapeutics Co., Ltd.
Orthopedic · 162d
Cleared Mar 06, 2024
BD SmartSite™ 13mm Vial Access Device
K233021 · LHI
Care Fusion
General Hospital · 166d
Cleared Mar 06, 2024
Disposable Bipolar Forceps
K232703 · GEI
Jiangsu Hope Biomedical Science &...
General & Plastic Surgery · 183d
Cleared Mar 06, 2024
CurrentBody Skin RF
K232424 · PAY
El Global Trade, Ltd.
General & Plastic Surgery · 208d
Cleared Mar 06, 2024
DVT Motion Pneumatic Compression Device
K232270 · JOW
Koge Micro Tech Co., Ltd.
Cardiovascular · 219d
Cleared Mar 06, 2024
Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water...
K232004 · ODC
Medivators (A Subsidiary of Steris...
Gastroenterology & Urology · 244d
Cleared Mar 06, 2024
Gynethotics™ Pessary
K231786 · HHW
Cosm Medical
Obstetrics & Gynecology · 260d
Cleared Mar 06, 2024
EdgeFlow UH10
K231677 · IYO
Edgecare, Inc.
Radiology · 271d
Cleared Mar 06, 2024
Choledochoscope System
K231497 · FBN
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 287d
Cleared Mar 06, 2024
evoDrill Cranial Perforator
K231403 · HBF
Evonos GmbH & Co. KG
Neurology · 296d
Cleared Mar 05, 2024
TERA HARZ CLEAR
K240597 · NXC
Graphy, Inc.
Dental · 1d
Cleared Mar 05, 2024
Cerament Bone Void Filler
K240459 · MQV
Bonesupport AB
Orthopedic · 18d
Cleared Mar 05, 2024
NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
K240404 · MQV
Novabone Products, LLC
Orthopedic · 25d
Cleared Mar 05, 2024
Argo Knotless GENESYS Anchor
K240090 · MAI
Conmed Corporation
Orthopedic · 53d
Cleared Mar 05, 2024
Stelo Glucose Biosensor System
K234070 · SAF
Dexcom, Inc.
Chemistry · 74d
Cleared Mar 05, 2024
BASIS FLOW II
K233859 · EBI
YAMAHACHI DENTAL MFG., Co.
Dental · 90d
Cleared Mar 05, 2024
Medline Open-back Level 3 Protective Gown
K233526 · QPC
Medline Industries, LP
General Hospital · 125d
Cleared Mar 05, 2024
HTx Disposable Hysteroscope System
K231260 · HIH
Suzhou AcuVu Medical Technology Co.,...
Obstetrics & Gynecology · 309d
Cleared Mar 05, 2024
DGA Abutment
K231210 · NHA
Modern Dental Laboratory (Dg) Co., Ltd.
Dental · 313d
Cleared Mar 04, 2024
ReBOSSIS
K240453 · MQV
Orthorebirth Co., Ltd.
Orthopedic · 18d
Cleared Mar 04, 2024
XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)
K233877 · ITI
Magic Mobility
Physical Medicine · 88d