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
9721–9744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2023
Pre-Sutured Tendon (4561SC / Single Strand)
K230036 · GAT
Rti Surgical, Inc.
General & Plastic Surgery · 178d
Cleared Jun 23, 2023
Neodent Implant System - Helix Short Implant System
K223638 · DZE
Jjgc Industria E Comercio DE...
Dental · 200d
Cleared Jun 23, 2023
HemosIL Liquid Anti-Xa
K223187 · QLU
Instrumentation Laboratory CO
Hematology · 254d
Cleared Jun 23, 2023
Radixact Treatment Delivery System
K223159 · IYE
Accuray Incorporated
Radiology · 259d
Cleared Jun 23, 2023
Medisystem Pacs
K223048 · LLZ
Medilab Manutencao E Sitemas Ltda
Radiology · 267d
Cleared Jun 23, 2023
sam 2.0 Long Ultrasound Device
K223019 · PFW
ZetrOZ Systems, LLC
Physical Medicine · 267d
Cleared Jun 23, 2023
AccurECG Analysis System
K223013 · DPS
Accurkardia, Inc.
Cardiovascular · 267d
Cleared Jun 23, 2023
Virtus Metabolic Monitor
K222982 · BTY
Virtus Technology Aps
Anesthesiology · 268d
Cleared Jun 23, 2023
FERTI-LILY Conception Cup
K222969 · HDR
Rosesta Medical BV
Obstetrics & Gynecology · 269d
Cleared Jun 23, 2023
AltiVate® Anatomic Shoulder AG e+™ with Markers
K222592 · KWS
Encore Medical, L.P.
Orthopedic · 301d
Cleared Jun 23, 2023
Black Diamond
K222323 · PHR
Elevate Oral Care, LLC
Dental · 325d
Cleared Jun 23, 2023
Mais Central Venous Catheter
K221827 · FOZ
Saudi Mais Co. For Medical Products
General Hospital · 365d
Cleared Jun 23, 2023
Surflo Winged Infusion Set
K221411 · FPA
Terumo Medical Products Hangzhou Co.,...
General Hospital · 403d
Cleared Jun 23, 2023
Hudson RCI Variable concentration Large Volume Nebulizer (1770)
K220955 · CAF
Medline Industires, Inc.
Anesthesiology · 448d
Cleared Jun 22, 2023
QuickRayPRO
K231202 · MUH
Denterprise International, Inc.
Radiology · 56d
Cleared Jun 22, 2023
Diode Laser Body Sculpture Systems
K231131 · PKT
Shanghai Bele Medical Technology Co.,Ltd
General & Plastic Surgery · 62d
Cleared Jun 22, 2023
Arthrex Virtual Implant Positioning (VIP) System
K230904 · QHE
Arthrex, Inc.
Orthopedic · 83d
Cleared Jun 22, 2023
TargetCool™
K230599 · GEH
Recensmedical, Inc.
General & Plastic Surgery · 111d
Cleared Jun 22, 2023
Bladder AI (AIBV01)
K230497 · QIH
Exo, Inc.
Radiology · 118d
Cleared Jun 22, 2023
Talee, Talee PostOp
K230444 · MVA
Invent Medical USA, LLC
Neurology · 121d
Cleared Jun 22, 2023
SelectFlex Neurovascular Access System Family
K230322 · QJP
Q'Apel Medical, Inc.
Neurology · 136d
Cleared Jun 22, 2023
Miria Skin Treatment System
K223871 · ONG
Avava, Inc.
General & Plastic Surgery · 181d
Cleared Jun 22, 2023
Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use...
K223741 · FBN
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 190d
Cleared Jun 22, 2023
CUVIS-spine
K223558 · OLO
Curexo, Inc.
Orthopedic · 206d