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

Filters: Cleared only ×
175,230 results
5617–5640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2024
gentleheel® Adult Incision Device
K242664 · FMK
Gri-Alleset, Inc.
General & Plastic Surgery · 62d
Cleared Nov 05, 2024
Delphi Stimulator
K242345 · GWF
Quantalx Neuroscience
Neurology · 90d
Cleared Nov 05, 2024
DESS Dental Smart Solutions
K242340 · NHA
Terrats Medical SL
Dental · 90d
Cleared Nov 05, 2024
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341,...
K242332 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 90d
Cleared Nov 05, 2024
MEDRAD Centargo CT Injection System
K241849 · IZQ
Imaxeon Pty, Ltd.
General Hospital · 131d
Cleared Nov 05, 2024
Atlas™ Humeral Nail System
K241484 · HSB
Orthopedic Designs North America,...
Orthopedic · 165d
Cleared Nov 05, 2024
TeraRecon Cardiac.Chambers.MR (1.0.0)
K241312 · QIH
Terarecon,Inc.
Radiology · 180d
Cleared Nov 05, 2024
InfuLife
K240624 · MEB
First Medical Source, LLC
General Hospital · 245d
Cleared Nov 05, 2024
POTENZA
K231287 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 551d
Cleared Nov 04, 2024
SonoStik Guide Wire Introducer
K243061 · DYB
Sonostik, LLC
Cardiovascular · 38d
Cleared Nov 04, 2024
JLK-PWI
K242709 · LLZ
JLK, Inc.
Radiology · 56d
Cleared Nov 04, 2024
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator...
K242567 · NUH
Changsha Anxiang Medical Technology...
Physical Medicine · 67d
Cleared Nov 04, 2024
Gemini Cervical Fusion Cage System
K242195 · ODP
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 101d
Cleared Nov 04, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K240637 · NBW
Bionime Corporation
Chemistry · 243d
Cleared Nov 04, 2024
Tixel i (TXLI0001)
K240512 · ORZ
Novoxel , Ltd.
Ophthalmic · 256d
Cleared Nov 04, 2024
CDB Hospital ® Sterilization Wrap (70 gsm)
K240438 · FRG
Comercializadora Brever
General Hospital · 264d
Cleared Nov 01, 2024
Total Wrist Arthroplasty System (TWA)
K243381 · JWJ
Skeletal Dynamics, Inc.
Orthopedic · 2d
Cleared Nov 01, 2024
Legend X Desktop System
K243217 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 29d
Cleared Nov 01, 2024
Over-tube (TR-1108A)
K243091 · FED
Fujifilm Corporation
Gastroenterology & Urology · 32d
Cleared Nov 01, 2024
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37...
K242675 · KLE
Spident Co., Ltd.
Dental · 56d
Cleared Nov 01, 2024
DePuy ATTUNE™ Total Knee System
K242665 · OIY
Depuy Orthopedics, Inc.
Orthopedic · 58d
Cleared Nov 01, 2024
Breo Laser Hair Growth Comb (Scalp 3L)
K242620 · OAP
Shenzhen Breo Technology Co., Ltd.
General & Plastic Surgery · 59d
Cleared Nov 01, 2024
XERO-alpha
K242591 · EHD
DRTECH Corporation
Radiology · 63d
Cleared Nov 01, 2024
Monkey Bars Pin to Bar External Fixation System
K242452 · KTT
Paragon 28, Inc.
Orthopedic · 74d