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
8641–8664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2023
IPL Cooling Hair Removal Device
K232845 · OHT
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 61d
Cleared Nov 14, 2023
BLU TOTALE (Model: ENEOB852)
K232656 · OLP
Premier North America, Inc.
General & Plastic Surgery · 75d
Cleared Nov 14, 2023
MAGNETOM Avanto fit
K232494 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 14, 2023
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for...
K232461 · LZA
Kossan International Sdn Bhd
General Hospital · 91d
Cleared Nov 14, 2023
Great Basin Toxigenic C. difficile Direct Test (CDF2)
K232092 · OZN
Vela Operations USA
Microbiology · 124d
Cleared Nov 14, 2023
saremco print BRIDGETEC
K232050 · EBF
Saremco Dental AG
Dental · 127d
Cleared Nov 14, 2023
VitroPRO
K231783 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 151d
Cleared Nov 14, 2023
UniPearls® Embolic Microspheres
K231554 · KRD
Suzhou Haowei Medical Technology Co.,...
Gastroenterology & Urology · 168d
Cleared Nov 14, 2023
Broncho Videoscope System
K231521 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 172d
Cleared Nov 14, 2023
Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow,...
K231097 · NHA
Prismatik Dentalcraft, Inc.
Dental · 210d
Cleared Nov 14, 2023
QScout Lab
K230878 · GKZ
Ad Astra Diagnostics, Inc.
Hematology · 229d
Cleared Nov 14, 2023
BrainSpec Core™ Software
K230856 · LLZ
Brainspec, Inc.
Radiology · 230d
Cleared Nov 13, 2023
Accu-Chek Safe-T-Pro Uno Lancing Device
K232509 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 87d
Cleared Nov 13, 2023
Accu-Chek Safe-T-Pro Plus Lancing Device
K232488 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 88d
Cleared Nov 13, 2023
Clarius Bladder AI
K232257 · QIH
Clarius Mobile Health Corp.
Radiology · 108d
Cleared Nov 13, 2023
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815,...
K232241 · NEY
Betters(Suzhou) Medical Co., Ltd.
General & Plastic Surgery · 108d
Cleared Nov 13, 2023
Microwave Ablation System (BD-GT)
K232240 · NEY
Betters(Suzhou) Medical Co., Ltd.
General & Plastic Surgery · 108d
Cleared Nov 13, 2023
BriefCase-Quantification
K232083 · QIH
Aidoc Medical , Ltd.
Radiology · 123d
Cleared Nov 13, 2023
Foundation Dermal Regeneration Scaffold (DRS) Solo
K231937 · KGN
Bionova Medical, Inc.
General & Plastic Surgery · 136d
Cleared Nov 13, 2023
Cystoscope System
K231118 · FAJ
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 207d
Cleared Nov 13, 2023
ELLAVI UBT
K230849 · OQY
Sinapi Biomedical (Pty) , Ltd.
Obstetrics & Gynecology · 230d
Cleared Nov 13, 2023
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
K230831 · MBF
Depuy Ireland UC
Orthopedic · 231d
Cleared Nov 10, 2023
Skin and Wound Cleanser
K231564 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 163d
Cleared Nov 09, 2023
VarseoSmile TriniQ
K233596 · EBF
Bego Bremer Goldschl?gerei Wilh....
Dental · 1d