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
5809–5832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2024
Elucid PlaqueIQ
K241524 · LLZ
Elucid Bioimaging, Inc.
Radiology · 106d
Cleared Sep 12, 2024
Glidewell™ 3DP Denture Base Resin
K241493 · EBI
Prismatik Dentalcraft, Inc.
Dental · 107d
Cleared Sep 12, 2024
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8...
K241432 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 114d
Cleared Sep 12, 2024
Constellation (CON-001)
K241280 · QIH
Q Bio, Inc.
Radiology · 128d
Cleared Sep 12, 2024
Orthopantomograph™ OP 3D LX (PAN 3D)
K241249 · OAS
Palodex Group OY
Radiology · 132d
Cleared Sep 12, 2024
CINA-CSpine
K240942 · QAS
Avicenna.Ai
Radiology · 160d
Cleared Sep 12, 2024
VitalFlow Set with Balance Biosurface
K240880 · QJZ
Medtronic, Inc.
Cardiovascular · 164d
Cleared Sep 12, 2024
Surgikor Fixation One, Abutment Blanks and Abutments
K240803 · DZE
Surgikor, LLC
Dental · 171d
Cleared Sep 12, 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791)
K240787 · DQY
Biotronik, Inc.
Cardiovascular · 174d
Cleared Sep 12, 2024
N7-S
K240168 · JFB
Nuga Medical Co., Ltd.
Physical Medicine · 234d
Cleared Sep 12, 2024
CoolSculpting Elite System
K233732 · OOK
Zeltiq Aesthetics, Inc. (Acquired by...
General & Plastic Surgery · 296d
Cleared Sep 12, 2024
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood...
K231982 · DTZ
Qura S.R.L
Cardiovascular · 435d
Cleared Sep 12, 2024
Hipro Glycosylated Hemoglobin (HbA1c) Test System
K220999 · PDJ
Shijiazhuang Hipro Biotechnology Co.,...
Chemistry · 892d
Cleared Sep 11, 2024
SonoBlock
K241954 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 70d
Cleared Sep 11, 2024
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46...
K241745 · LZA
Ksg Medicare Sdn. Bhd.
General Hospital · 85d
Cleared Sep 11, 2024
Signus Tetris™ St
K241438 · MAX
Signus Medizintechnik GmbH
Orthopedic · 113d
Cleared Sep 11, 2024
FETOLY-HEART
K241380 · IYN
Diagnoly
Radiology · 119d
Cleared Sep 11, 2024
Pounce XL Thrombectomy System (PTS-1011-7F135)
K241362 · QEW
Surmodics,Inc.
Cardiovascular · 120d
Cleared Sep 11, 2024
Ultrasound Imaging System (LK128L)
K241161 · IYN
Leltek, Inc.
Radiology · 138d
Cleared Sep 11, 2024
HEALIX ADVANCE Knotless anchors
K241010 · MAI
Depuy Mitek
Orthopedic · 152d
Cleared Sep 11, 2024
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3,...
K241004 · HGX
Huizhou Lvb Maternal and Infant...
Obstetrics & Gynecology · 152d
Cleared Sep 11, 2024
Rx Knee System
K240683 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 183d
Cleared Sep 11, 2024
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K240271 · BZQ
Linshom Medical, Inc.
Anesthesiology · 224d
Cleared Sep 11, 2024
C&B NFH Hybrid
K232559 · EBF
Arum Dentistry Co., Ltd.
Dental · 385d