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
9841–9864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2023
Bemer Therapy System Evo
K231368 · NGX
Bemer Int AG
Physical Medicine · 29d
Cleared Jun 09, 2023
RODIN™ Expandable Lumbar Cage System
K231359 · MAX
Ctl Medical Corporation
Orthopedic · 30d
Cleared Jun 09, 2023
BruxZir™ TintEFX Coloring Liquid
K231347 · EIH
Prismatik Dentalcraft, Inc.
Dental · 31d
Cleared Jun 09, 2023
MyKnee UNI-ST
K231037 · JWH
Medacta International S.A.
Orthopedic · 58d
Cleared Jun 09, 2023
DJF Intravascular Administration Set
K230992 · FPA
Yangzhou Wei DE LI Trade Co., Ltd.
General Hospital · 64d
Cleared Jun 09, 2023
OrthoPulse 2.0E (OPi2E-100)
K230905 · PLH
Biolux Technology GmbH
Dental · 70d
Cleared Jun 09, 2023
Fixone Biocomposite Anchor
K230892 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 70d
Cleared Jun 09, 2023
Powder Free Nitrile Examination Gloves (Black), Tested for Use with...
K230779 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 80d
Cleared Jun 09, 2023
Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
K230776 · HGX
Shenzhen Lutejiacheng Technology Co.,...
Obstetrics & Gynecology · 80d
Cleared Jun 09, 2023
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9...
K230768 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 81d
Cleared Jun 09, 2023
Acumed Acutrak 3 Headless Compression Screw System
K230744 · HWC
Acumed, LLC
Orthopedic · 84d
Cleared Jun 09, 2023
JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
K230728 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 85d
Cleared Jun 09, 2023
Auryon Atherectomy System
K230709 · MCW
Eximo Medical, Ltd.
Cardiovascular · 87d
Cleared Jun 09, 2023
Renuvion® Micro Handpiece
K230586 · GEI
Apyx Medical Corporation
General & Plastic Surgery · 99d
Cleared Jun 09, 2023
Gamma4 System
K230512 · HSB
Stryker GmbH
Orthopedic · 105d
Cleared Jun 09, 2023
Orthopantomograph™ OP 3D LX
K230505 · OAS
Palodex Group OY
Radiology · 105d
Cleared Jun 09, 2023
Ear Pressure Relief Device(Model:ER813B)
K230502 · MJV
Ningbo Albert Novosino Co., Ltd.
Ear, Nose, Throat · 105d
Cleared Jun 09, 2023
TheraFace Mask
K230293 · OHS
Therabody, Inc.
General & Plastic Surgery · 127d
Cleared Jun 09, 2023
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted...
K223865 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 168d
Cleared Jun 09, 2023
CT Perfusion V1.0
K223091 · LLZ
Olea Medical
Radiology · 252d
Cleared Jun 09, 2023
LVIS NeuroMatch
K222450 · OMB
LVIS Corporation
Neurology · 298d
Cleared Jun 09, 2023
NovoGen Wound Matrix
K220498 · KGN
Novabone Products, LLC
General & Plastic Surgery · 472d
Cleared Jun 08, 2023
OCD MT Cap (85-00397-000)
K231350 · QCI
Neuronetics
Neurology · 30d
Cleared Jun 08, 2023
Disposable Laparoscopic Trocar
K231042 · GCJ
Changzhou Ankang Medical Instruments...
General & Plastic Surgery · 57d