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
7057–7080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2024
Zenition 90
K240224 · OWB
Philips Medical Systems Nederlands B.V.
Radiology · 117d
Cleared May 22, 2024
IntraOp Alignment System
K240199 · OWB
Alphatec Spine, Inc.
Radiology · 118d
Cleared May 22, 2024
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
K240097 · QSY
Ushare Medical, Inc.
General & Plastic Surgery · 131d
Cleared May 22, 2024
INUMI™ Flex Needle
K233884 · OAB
Galvanize Therapeutics, Inc.
General & Plastic Surgery · 166d
Cleared May 22, 2024
Fogarty Arterial Embolectomy Catheter with Gate Valve
K233820 · DXE
Edwards Lifesciences
Cardiovascular · 173d
Cleared May 22, 2024
Fogarty Venous Thrombectomy Catheters
K233819 · DXE
Edwards Lifesciences, LLC
Cardiovascular · 173d
Cleared May 22, 2024
Impress Angiographic Catheter
K233268 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 236d
Cleared May 22, 2024
Gladiator
K233099 · GEI
Rohrer Aesthetics, LLC
General & Plastic Surgery · 239d
Cleared May 22, 2024
Paltop Short Implants
K232740 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 258d
Cleared May 22, 2024
Bonvadis®
K232655 · FRO
Stemcyte, Inc.
General & Plastic Surgery · 265d
Cleared May 21, 2024
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A...
K241110 · OZE
Centers For Disease Control and...
Microbiology · 29d
Cleared May 21, 2024
Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
K240806 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared May 21, 2024
ProSeal™ Injection Site Extended Male Luer Lock (422140)
K240433 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 97d
Cleared May 21, 2024
YSIO X.pree
K233543 · KPR
Siemens Medical Solutions
Radiology · 200d
Cleared May 21, 2024
troCarWash™ System
K233442 · OCX
Biotex, Inc.
General & Plastic Surgery · 216d
Cleared May 21, 2024
21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
K233336 · PGY
Acula Technology Corp.
Radiology · 235d
Cleared May 21, 2024
Yumizen H2500
K232946 · GKZ
HORIBA ABX SAS
Hematology · 244d
Cleared May 21, 2024
Viewer (5.4)
K232759 · LLZ
Brainlab AG
Radiology · 256d
Cleared May 21, 2024
Reia pessary
K232677 · HHW
Reia, LLC
Obstetrics & Gynecology · 263d
Cleared May 20, 2024
Vector™ Pedicle Screw System
K241276 · NKB
Innovasis, Inc.
Orthopedic · 14d
Cleared May 20, 2024
Disposable Vinyl Examination Gloves
K241252 · LYZ
Anqing Pukang Medical Technology Co.,...
General Hospital · 17d
Cleared May 20, 2024
Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML,...
K240772 · EIH
Hunan Ceramaster Material Technology...
Dental · 60d
Cleared May 20, 2024
Diode Laser Hair Removal System (SH-VD910)
K240520 · GEX
Beijing Sea Heart International...
General & Plastic Surgery · 87d
Cleared May 20, 2024
Dentis s-Clean SQ-SL Fixture
K240511 · DZE
Dentis Co., Ltd.
Dental · 88d