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
4057–4080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2025
Fetal EchoScan (v1.1)
K251071 · POK
Brightheart
Radiology · 25d
Cleared May 02, 2025
Anovo Instrument ARM Curved Scissors
K251056 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 28d
Cleared May 02, 2025
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
K251048 · JOJ
STERIS Corporation
General Hospital · 29d
Cleared May 02, 2025
Sutil Rich Personal Lubricant
K250629 · NUC
Hathor Professional Skincare , Ltd.
Obstetrics & Gynecology · 60d
Cleared May 02, 2025
OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
K250292 · FOZ
Skydance Vascular, Inc.
General Hospital · 91d
Cleared May 02, 2025
Wrist Blood Pressure Monitor (AOJ-35A)
K250161 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 101d
Cleared May 02, 2025
i-STAT CG4+ cartridge with the i-STAT 1 System
K244014 · CHL
Abbott Point of Care, Inc.
Chemistry · 127d
Cleared May 02, 2025
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1)
K244001 · FBO
Karl Storz SE & CO. KG
Gastroenterology & Urology · 127d
Cleared May 02, 2025
F88 URE-SD/RD Flexible Ureteroscope
K243894 · FGB
Sg Endoscopy Pte, Ltd.
Gastroenterology & Urology · 135d
Cleared May 02, 2025
CIONIC NEURAL SLEEVE (NS-200)
K243828 · GZI
Cionic, Inc.
Physical Medicine · 140d
Cleared May 02, 2025
Shockwave CS Guide Catheter
K243757 · DQY
Shockwave Medical, Inc.
Cardiovascular · 147d
Cleared May 02, 2025
Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel
K243457 · FRO
Seriously Clean, Ltd.
General & Plastic Surgery · 176d
Cleared May 02, 2025
SQA-iOw Sperm Quality Analyzer
K243114 · POV
Medical Electronic Systems , Ltd.
Hematology · 214d
Cleared May 02, 2025
LUMYS (V1)
K243069 · LLZ
Intradys
Radiology · 217d
Cleared May 02, 2025
Origin™ Cemented Hip Stem
K243043 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 217d
Cleared May 02, 2025
SpO2 Extension Cable
K242986 · DSA
Beijing Rongrui-Century Science &...
Anesthesiology · 218d
Cleared May 02, 2025
JetCan® Pro Safety Huber Needle
K242763 · FPA
Pfm Medical, Inc.
General Hospital · 232d
Cleared May 02, 2025
AT-Patch (ATP-C130/ATP-C70)
K242583 · DSH
Atsens Co., Ltd.
Cardiovascular · 245d
Cleared May 01, 2025
APRO 45 Catheter
K251014 · DQY
Alembic, LLC
Neurology · 29d
Cleared May 01, 2025
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,...
K251007 · DXF
Circa Scientific, Inc.
Cardiovascular · 30d
Cleared May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250996 · QOF
Cepheid
Microbiology · 30d
Cleared May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250995 · QOF
Cepheid
Microbiology · 30d
Cleared May 01, 2025
APEX 3D Total Ankle Replacement System
K250641 · HSN
Paragon 28, Inc.
Orthopedic · 58d
Cleared May 01, 2025
Disposable Distal Attachment D-201 Series
K250296 · FDS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d