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
4033–4056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2025
Lumify Diagnostic Ultrasound System
K242670 · IYN
Philips Ultrasound
Radiology · 245d
Cleared May 08, 2025
NextStep Arthropedix Total Knee System
K242410 · JWH
Nextstep Arthropedix
Orthopedic · 267d
Cleared May 08, 2025
OsseOne Dental Implant System
K233271 · DZE
Synoross Dba Osseone
Dental · 587d
Cleared May 07, 2025
Extremity Medical External Fixation System
K251128 · KTT
Extremity Medical, LLC
Orthopedic · 26d
Cleared May 07, 2025
Cary
K251111 · JCX
Excitus AS
General & Plastic Surgery · 26d
Cleared May 07, 2025
SDF Pro
K250222 · PHR
Belport Company, Inc., Gingi-Pak
Dental · 100d
Cleared May 07, 2025
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed)
K243776 · MOB
Zeus Scientific
Immunology · 149d
Cleared May 07, 2025
BrightHeart View Classifier
K243684 · QIH
Brightheart
Radiology · 159d
Cleared May 07, 2025
Mobility Scooter (Model X-01, X-02)
K242975 · INI
Wuyi Aichi Industry & Trade Co., Ltd.
Physical Medicine · 223d
Cleared May 06, 2025
Alma Veil
K251094 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 26d
Cleared May 06, 2025
Single-use Flexible Ureteroscope
K250785 · FGB
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 53d
Cleared May 06, 2025
IPL Hair Removal Device (KCA511/KCA516/KCA522)
K250253 · OHT
Dongguan Boyuan Intelligent...
General & Plastic Surgery · 98d
Cleared May 06, 2025
ANKYRAS
K250160 · PZO
Mentice Spain S.L.
Neurology · 105d
Cleared May 06, 2025
IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)
K243017 · OHT
Foshan Newface Electronic Technology...
General & Plastic Surgery · 221d
Cleared May 06, 2025
!M1
K241980 · IZL
Solutions For Tomorrow AB
Radiology · 305d
Cleared May 05, 2025
Arthrex Synergy Vision Endoscopic Imaging System
K250728 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 55d
Cleared May 05, 2025
Second Opinion® Pediatric
K243893 · MYN
Pearl, Inc.
Radiology · 138d
Cleared May 05, 2025
AeviceMD
K243603 · DSH
Aevice Health Pte. , Ltd.
Anesthesiology · 165d
Cleared May 05, 2025
DentaTOOTH
K243370 · EBG
Asiga Pty, Ltd.
Dental · 187d
Cleared May 05, 2025
Telemetry Monitor 5500 Release 4.0 (867232)
K242962 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 222d
Cleared May 05, 2025
Dream Medi Sterile Surgical Gown (SurgicalGownUL)
K242937 · FYA
Dae Myung Chemical Co., Ltd. (Vietnam)
General Hospital · 222d
Cleared May 05, 2025
ZT Clinic (MG675A)
K242754 · IRP
Zamar Medical D.O.O.
Physical Medicine · 235d
Cleared May 05, 2025
Bluemoon
K242386 · EBZ
Genoss Co., Ltd.
Dental · 266d
Cleared May 05, 2025
ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure...
K240447 · MLW
Thermasolutions, LLC
Gastroenterology & Urology · 445d