FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
27889–27912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2017
Ablatherm Fusion
K172285 · PLP
Edap Technomed, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 03, 2017
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
K172621 · JTN
Hardy Diagnostics
Microbiology · 33d
Cleared Oct 03, 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684 · LPH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Oct 03, 2017
Arisure Closed Vial Adapter
K172884 · LHI
Yukon Medical
General Hospital · 12d
Cleared Oct 02, 2017
Yooeehouse Breast Pump
K163183 · HGX
Nantong Poly Technology Co., Ltd.
Obstetrics & Gynecology · 322d
Cleared Oct 02, 2017
iSurg
K170054 · GEI
Jaco, LLC Dba Macan Manufacturing and...
General & Plastic Surgery · 269d
Cleared Oct 02, 2017
Nobilplast Denture Resin
K170375 · EBI
Cmp Industries, LLC
Dental · 237d
Cleared Oct 02, 2017
ECG Check - Universal, ECG Check - Universal Plus
K170506 · DXH
Cardiac Designs, Inc.
Cardiovascular · 223d
Cleared Oct 02, 2017
Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque...
K170873 · EBF
Swissmeditec GmbH
Dental · 193d
Cleared Oct 02, 2017
BRIDALVEIL Occipital Cervical Thoracic System
K171250 · NKG
Astura Medical
Orthopedic · 157d
Cleared Oct 02, 2017
Trident® II Acetabular System
K171768 · LPH
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 110d
Cleared Oct 02, 2017
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978 · IPF
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 94d
Cleared Oct 02, 2017
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder...
K172210 · KWS
Stryker Trauma AG
Orthopedic · 70d
Cleared Oct 02, 2017
Large Screws Range
K172596 · HWC
Newclip Technics
Orthopedic · 34d
Cleared Sep 29, 2017
SmartEP
K163326 · GWJ
Intelligent Hearing Systems
Neurology · 305d
Cleared Sep 29, 2017
Confirm Rx Insertable Cardiac Monitor (ICM) System
K163407 · MXC
St. Jude Medical, Inc.
Cardiovascular · 298d
Cleared Sep 29, 2017
Calix Lumbar Spinal Implant System
K170119 · MAX
X-Spine Systems, Inc.
Orthopedic · 259d
Cleared Sep 29, 2017
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast...
K170166 · GAM
Cpt Sutures Co., Ltd.
General & Plastic Surgery · 253d
Cleared Sep 29, 2017
SecurePortIV Catheter Securement Adhesive
K170505 · NZP
Adhezion Biomedical, LLC
General Hospital · 220d
Cleared Sep 29, 2017
BR-FHUS Navigation 1.0
K171309 · IYO
Taihao Medical, Inc.
Radiology · 149d
Cleared CT Sep 29, 2017
Carbon Monoxide Breath Sensor System (COBSS)
K171408 · CCJ
Carrot Sense, Inc.
Toxicology · 140d
Cleared Sep 29, 2017
Berkeley VC-10 Vacuum Curettage System
K171440 · HHI
Gyrus Acmi
Obstetrics & Gynecology · 136d
Cleared Sep 29, 2017
ASPIRE Bellus II
K171463 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 134d
Cleared Sep 29, 2017
Med4 Elite
K171685 · IRP
Cool Systems, Inc. (Dba Game Ready)
Physical Medicine · 114d