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
11929–11952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2022
PosiSep X BAM Hemostat Dressing/Intranasal Splint
K220326 · EMX
Hemostasis, LLC
Ear, Nose, Throat · 283d
Cleared Nov 14, 2022
Hexanium ACIF
K221578 · OVE
Spinevision, S.A.S.
Orthopedic · 166d
Cleared Nov 14, 2022
Multiflex Steerable Sheath
K221655 · DYB
Vizaramed, Inc.
Cardiovascular · 160d
Cleared Nov 14, 2022
Syngo Dynamics (Version VA40F)
K222428 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 95d
Cleared Nov 14, 2022
Standard Surgical Gown (AAMI Level 2)
K222480 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 89d
Cleared Nov 14, 2022
HBL Blade Assembly
K222490 · HRX
Hand Biomechanics Lab, Inc.
Orthopedic · 89d
Cleared Nov 14, 2022
Zirconia Block
K222520 · EIH
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 87d
Cleared Nov 14, 2022
Surgical Face Mask
K222529 · FXX
Xiantao Rayxin Medical Products Co.,...
General Hospital · 84d
Cleared Nov 14, 2022
uPMR 790
K222540 · OUO
Shanghai United Imaging Healthcare...
Radiology · 84d
Cleared Nov 14, 2022
High Fluid-Resistant Surgical and Procedure Mask
K222749 · FXX
America?S Supply Chains
General Hospital · 63d
Cleared Nov 12, 2022
Nitrile Examination Gloves
K213981 · LZA
Emerald Glove Manufacturing Sdn Bhd
General Hospital · 327d
Cleared Nov 11, 2022
Mapping Suction Probe
K212164 · ETN
Inomed Medizintechnik GmbH
Neurology · 487d
Cleared Nov 11, 2022
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
K220983 · IYN
Imsonic Medical China, Inc.
Radiology · 221d
Cleared Nov 11, 2022
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K222225 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 109d
Cleared Nov 10, 2022
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima...
K211934 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 506d
Cleared Nov 10, 2022
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid,...
K211954 · GYC
Spes Medica Srl
Neurology · 505d
Cleared Nov 10, 2022
Dermal Cooling System
K213294 · QPZ
R2 Technologies, Inc.
General & Plastic Surgery · 405d
Cleared Nov 10, 2022
AMSure Enteral Feeding Pump
K220230 · LZH
Amsino International, Inc.
General Hospital · 287d
Cleared Nov 10, 2022
Tandry CMF Plate System
K220360 · JEY
Microware Precision Co., Ltd.
Dental · 275d
Cleared Nov 10, 2022
AVIEW RT ACS
K220408 · QKB
Coreline Soft Co., Ltd.
Radiology · 269d
Cleared Nov 10, 2022
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
K220562 · NHA
Megagen Implant Co., Ltd.
Dental · 255d
Cleared Nov 10, 2022
10PL
K220794 · ONF
Tentech Co. , Ltd.
General & Plastic Surgery · 237d
Cleared Nov 10, 2022
FUJIFILM Endoscope Model EB-710P
K220957 · EOQ
Fujifilm Corporaton
Ear, Nose, Throat · 223d
Cleared Nov 10, 2022
Bodygard SFS Surgical Gown Level 4
K221139 · FYA
Feliks Plastik Laminasyon VE Ambalaj...
General Hospital · 205d