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
11593–11616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2022
CODA™ Anterior Cervical Plate System
K222493 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 92d
Cleared Nov 18, 2022
Electromed SmartVest Airway Clearance System
K222496 · BYI
Electromed, Inc.
Anesthesiology · 92d
Cleared Nov 18, 2022
OCS Lung Donor Flush Set
K222535 · MSB
TransMedics, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 18, 2022
Facet Blood Lancets
K222539 · QRL
Facet Technologies, LLC
General & Plastic Surgery · 88d
Cleared Nov 18, 2022
MANTA Laser
K222701 · GEX
Squalus Med , Ltd.
General & Plastic Surgery · 72d
Cleared Nov 18, 2022
Opulent TiNbN Coated Knee
K222816 · JWH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 60d
Cleared Nov 18, 2022
Tailored-H Cervical Stand Alone System
K222903 · OVE
Bespoke Technologies, LLC
Orthopedic · 56d
Cleared Nov 18, 2022
Banded Face Mask
K223003 · FXX
Hubei Medlink Healthcare Co., Ltd.
General Hospital · 50d
Cleared Nov 18, 2022
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
K223124 · MQB
DRTECH Corporation
Radiology · 46d
Cleared Nov 18, 2022
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
K223246 · BZQ
Baxter Healthcare Corproration
Anesthesiology · 29d
Cleared Nov 18, 2022
CONTOUR® NEXT GEN Blood Glucose Monitoring System
K223293 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 23d
Cleared Nov 17, 2022
TFX-LT2000 Therapy Light
K211265 · PDZ
Toefx, Inc.
General & Plastic Surgery · 570d
Cleared Nov 17, 2022
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
K212910 · EFB
Shenzhen Carejoy Technology Co., Ltd.
Dental · 430d
Cleared Nov 17, 2022
Supra Non-Stick Bipolar Forceps
K213042 · GEI
Guenter Bissinger Medizintechnik GmbH
General & Plastic Surgery · 421d
Cleared Nov 17, 2022
C.C. LIFE 21
K213295 · PBX
21 Equipment S.R.L.
General & Plastic Surgery · 412d
Cleared Nov 17, 2022
Dentca Base Premium, Dentca Base Hi-Impact
K220042 · EBI
Dentca, Inc.
Dental · 316d
Cleared Nov 17, 2022
Blood Administration Sets
K220558 · BRZ
Baxter Healthcare Corporation
General Hospital · 262d
Cleared Nov 17, 2022
Disposable Urine Collection Tube
K220739 · JSM
Zhejiang Gongdong Medical Technology...
Microbiology · 248d
Cleared Nov 17, 2022
Parky App
K220820 · GYD
H2o Bilisim Yazilim
Neurology · 241d
Cleared Nov 17, 2022
xvision Spine System
K220905 · SBF
Augmedics, Ltd.
Orthopedic · 234d
Cleared Nov 17, 2022
Disposable Insulin Pen Needle
K221178 · FMI
Ningbo Medsun Medical Co., Ltd.
General Hospital · 206d
Cleared Nov 17, 2022
Multitom Rax
K221281 · OWB
Siemens Medical Solutions
Radiology · 198d
Cleared Nov 17, 2022
Persona Personalized Knee System
K221479 · JWH
Zimmer, Inc.
Orthopedic · 178d
Cleared Nov 17, 2022
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
K221593 · EZD
Convatec, Inc.
Gastroenterology & Urology · 168d