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
10945–10968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2023
Electric breast pump (model: M5)
K223693 · HGX
Shenzhen Lutejiacheng Technology Co.,...
Obstetrics & Gynecology · 90d
Cleared Mar 09, 2023
Huvex Interspinous Fusion System
K223790 · PEK
Dio Medical Corp.
Orthopedic · 80d
Cleared Mar 09, 2023
CPS Locator 3D Delivery Catheter
K230363 · DQY
CenterPoint Systems, LLC
Cardiovascular · 27d
Cleared Mar 08, 2023
extriCARE 1000 Negative Pressure Wound Therapy System
K213906 · OMP
Alleva Medical, Ltd.
General & Plastic Surgery · 449d
Cleared Mar 08, 2023
Pulse Oximeter
K220101 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 420d
Cleared Mar 08, 2023
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb...
K220613 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 370d
Cleared Mar 08, 2023
SINEFIX
K220966 · MBI
BAAT Medical Products B.V.
Orthopedic · 341d
Cleared Mar 08, 2023
PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
K221209 · FXX
Padm Medical, Inc.
General Hospital · 316d
Cleared Mar 08, 2023
Arthrex Virtual Implant Positioning (VIP) System
K222007 · QHE
Arthrex, Inc.
Orthopedic · 244d
Cleared Mar 08, 2023
ManaSport+
K222098 · IMI
Manamed, Inc.
Physical Medicine · 233d
Cleared Mar 08, 2023
Cryo-Thermo Compression Device (FGK002)
K222136 · IRP
Suzhou Microport Rehabtech (Group)...
Physical Medicine · 232d
Cleared Mar 08, 2023
PathKeeper System
K222355 · OLO
Pathkeeper Surgical , Ltd.
Orthopedic · 216d
Cleared Mar 08, 2023
Respiree Cardio-Respiratory Monitor
K223681 · BZQ
Respiree Pte, Ltd.
Anesthesiology · 90d
Cleared Mar 08, 2023
CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments
K223688 · MAX
Medos International S?rl
Orthopedic · 89d
Cleared Mar 08, 2023
Dental Ceramic Blocks
K223742 · EBF
Aidite (Qinhuangdao) Technology Co.,...
Dental · 84d
Cleared Mar 08, 2023
Enhanced AURORA™ Medical Diode System, and related accessories
K230076 · FTC
Psoria-Shield, Inc.
General & Plastic Surgery · 57d
Cleared Mar 08, 2023
Persona™ Personalized Knee System
K230321 · JWH
Zimmer, Inc.
Orthopedic · 30d
Cleared Mar 07, 2023
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
K213892 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 448d
Cleared Mar 07, 2023
Visby Medical Sexual Health Test
K220407 · QEP
Visby Medical
Microbiology · 386d
Cleared Mar 07, 2023
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT...
K220549 · NEW
Hans Biomed Corporation
General & Plastic Surgery · 375d
Cleared Mar 07, 2023
Solero Microwave Tissue Ablation (MTA) System and Accessories
K221883 · NEY
AngioDynamics, Inc.
General & Plastic Surgery · 251d
Cleared Mar 07, 2023
Tyber Medical Anatomical Plating System
K222465 · HRS
Tyber Medical, LLC
Orthopedic · 204d
Cleared Mar 07, 2023
Enlight 2100
K222897 · QEB
Timpel S.A.
Anesthesiology · 165d
Cleared Mar 07, 2023
MedCAD AccuPlan System
K223024 · DZJ
Medcad
Dental · 159d