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
10009–10032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2023
General Cutting Straight
K230106 · EGS
Nakanishi, Inc.
Dental · 131d
Cleared May 24, 2023
SIMDA Abutment
K223663 · NHA
Simda Co., Ltd.
Dental · 168d
Cleared May 24, 2023
Reprieve by RegenesisTM
K223620 · IMJ
Regenesis Biomedical, Inc.
Physical Medicine · 170d
Cleared May 24, 2023
coactiv+™ Antimicrobial Wound Gel
K223259 · FRO
Kane Biotech, Inc.
General & Plastic Surgery · 212d
Cleared May 24, 2023
Avatar Medical Software V1
K222035 · LLZ
Avatar Medical
Radiology · 317d
Cleared May 24, 2023
Oxymag - Transport and Emergency Ventilator
K221634 · BTL
Magnamed Tecnologia Medica S/A
Anesthesiology · 352d
Cleared May 23, 2023
ACTERA™ hip system
K231178 · MEH
Conformis, Inc.
Orthopedic · 27d
Cleared May 23, 2023
ROSA Hip System
K231162 · LLZ
Orthosoft Inc. (d/b/a) Zimmer CAS
Radiology · 29d
Cleared May 23, 2023
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
K230874 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 54d
Cleared May 23, 2023
ADAS 3D
K230803 · LLZ
Adas3D Medical S.L.
Radiology · 61d
Cleared May 23, 2023
Green Non Sterile Powder Free Nitrile Examination Gloves
K230564 · LZA
Central Medicare Sdn Bhd
General Hospital · 83d
Cleared May 23, 2023
uMR Omega
K230152 · LNH
Shanghai United Imaging Healthcare...
Radiology · 124d
Cleared May 23, 2023
Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
K230134 · OAP
Hubei Yjt Technology Co.,Ltd
General & Plastic Surgery · 126d
Cleared May 23, 2023
Genius AI Detection 2.0 with CC-MLO Correlation
K230096 · QDQ
Hologic, Inc.
Radiology · 130d
Cleared May 23, 2023
Ceribell Status Epilepticus Monitor
K223504 · OMB
Ceribell, Inc.
Neurology · 182d
Cleared May 22, 2023
3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
K231464 · NXC
3M Company, Unitek Orthodontic Products
Dental · 3d
Cleared May 22, 2023
TracStar LDP Large Distal Platform
K231168 · QJP
Imperative Care, Inc.
Neurology · 27d
Cleared May 22, 2023
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)
K230708 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 69d
Cleared May 22, 2023
Kodiak™ Dual Port Coaxial Introducer Kit
K230631 · DYB
Argon Medical Devices
Cardiovascular · 76d
Cleared May 22, 2023
Hi-Bond Universal
K230465 · KLE
Mediclus Co., Ltd.
Dental · 90d
Cleared May 22, 2023
MixJect® Transfer Device
K230464 · LHI
West Pharma Services Il, Ltd.
General Hospital · 90d
Cleared May 22, 2023
Laser Thermal Therapy Kit
K230460 · GEX
Elesta S.P.A
General & Plastic Surgery · 90d
Cleared May 22, 2023
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
K230443 · NUH
Jiangxi Royall Smart Technology Co.,...
Neurology · 90d
Cleared May 22, 2023
HELIOS 785 Pico
K230373 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 98d