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
16609–16632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2021
Ear-Friendly Mask
K211105 · FXX
Ray Co., Ltd.
General Hospital · 34d
Cleared May 14, 2021
BoneTrust Mini Implant System
K200573 · DZE
Medical Instinct Deutschland GmbH
Dental · 435d
Cleared May 14, 2021
Cardiac Trigger Monitor
K202138 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 287d
Cleared May 14, 2021
Klarity Bolus
K202747 · IYE
Klarity Medical & Equipment (GZ) Co.,...
Radiology · 235d
Cleared May 14, 2021
Gx-IVF, Gx-TL, Gx-MOPS PLUS
K202862 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 228d
Cleared May 14, 2021
TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O...
K203226 · GCM
Richard Wolf Medical Instruments...
General & Plastic Surgery · 193d
Cleared May 14, 2021
HOLOSCOPE-i
K210072 · LLZ
Real View Imaging , Ltd.
Radiology · 123d
Cleared May 14, 2021
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle....
K210200 · FMF
Set Medikal Sanayi VE Ticaret Anonim...
General Hospital · 109d
Cleared May 14, 2021
Disposable Medical mask
K210302 · FXX
Anhui Jbh Medical Apparatus Co., Ltd.
General Hospital · 100d
Cleared May 14, 2021
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL,...
K210417 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 92d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210774 · LYZ
Shandong Jieshi Medical Products Co.,...
General Hospital · 60d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210780 · LYZ
Shandong Shangwei Medical Products...
General Hospital · 60d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves
K210799 · LYZ
Yunnan Huazhiyuan Medical Technology...
General Hospital · 59d
Cleared May 14, 2021
MicroFrance Monopolar and Bipolar Electrosurgical Instruments
K210942 · GEI
Integra Microfrance
General & Plastic Surgery · 45d
Cleared May 14, 2021
AcQGuide MAX Steerable Sheath
K211100 · DRA
Acutus Medical, Inc.
Cardiovascular · 31d
Cleared May 14, 2021
NPseal
K211130 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 28d
Cleared May 13, 2021
Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron...
K200555 · EMA
Prevest Denpro Limited
Dental · 436d
Cleared May 13, 2021
United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High...
K202697 · FXX
United Sewing Automation, Inc.
General Hospital · 239d
Cleared May 13, 2021
LinkSymphoKnee System
K202924 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 226d
Cleared May 13, 2021
CryoVIVE
K203481 · GEH
Recensmedical, Inc.
General & Plastic Surgery · 167d
Cleared May 13, 2021
Tablet Application
K203566 · ODA
Smith & Nephew
General & Plastic Surgery · 157d
Cleared May 13, 2021
Powder Free Nitrile Examination Glove
K210369 · LZA
Pastel Glove Sdn Bhd
General Hospital · 94d
Cleared May 13, 2021
HS40 Diagnostic Ultrasound System
K210426 · IYN
Samsung Medison Co., Ltd.
Radiology · 91d
Cleared May 13, 2021
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video...
K210485 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 83d