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
27721–27744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2017
Panther Fusion Paraflu Assay
K172282 · OOU
Hologic, Inc.
Microbiology · 87d
Cleared Oct 23, 2017
Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
K172343 · MAX
Rti Surgical, Inc.
Orthopedic · 82d
Cleared Oct 23, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.
K172542 · JWY
Liofilchem S. R. L.
Microbiology · 61d
Cleared Oct 23, 2017
AnyPlus® Spinal Fixation System
K172546 · NKB
GS Medical Co., Ltd.
Orthopedic · 61d
Cleared Oct 23, 2017
Liberty Anterior Cervical Plate
K172585 · KWQ
Valorus Spine
Orthopedic · 56d
Cleared Oct 23, 2017
gi-4000 Electrosurgical Generator
K172805 · GEI
United States Endoscopy Group, Inc.
General & Plastic Surgery · 35d
Cleared Oct 23, 2017
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
K173063 · OBJ
Acist Medical Systems, Inc.
Cardiovascular · 24d
Cleared Oct 20, 2017
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D
K160405 · IYE
Ptw-Freiburg...
Radiology · 612d
Cleared Oct 20, 2017
GingiDent Gingival Retraction Paste
K162662 · MVL
Pac-Dent International, Inc.
Dental · 389d
Cleared Oct 20, 2017
Quantra
K163623 · LLZ
Hologic, Inc.
Radiology · 302d
Cleared Oct 20, 2017
Sofia Lyme FIA, Sofia Lyme Control Set
K163713 · LSR
Quidel Corporation
Microbiology · 294d
Cleared Oct 20, 2017
MyKnee PPS-Pin Positioners
K170106 · JWH
Medacta International S.A.
Orthopedic · 281d
Cleared Oct 20, 2017
Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000...
K170150 · KDL
S.A.L.F. Spa
Gastroenterology & Urology · 276d
Cleared Oct 20, 2017
DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit...
K170371 · PNR
Intervene Group Limited
Gastroenterology & Urology · 256d
Cleared Oct 20, 2017
SafeSept Transseptal Guidewire
K170671 · DRC
Pressure Products Medical Device...
Cardiovascular · 228d
Cleared Oct 20, 2017
Ultimate Contour, Ultimate Contour Mini
K171052 · PBX
CAO Group, Inc.
General & Plastic Surgery · 193d
Cleared Oct 20, 2017
D'Vill Introducer
K171206 · DYB
NuMED, Inc.
Cardiovascular · 178d
Cleared Oct 20, 2017
ClearPoint System
K171257 · ORR
Mri Interventions, Inc.
Neurology · 175d
Cleared Oct 20, 2017
Accuro
K171594 · IYO
Rivanna Medical, LLC
Radiology · 142d
Cleared Oct 20, 2017
BR-FHUS Viewer 1.0
K171709 · LLZ
Taihao Medical, Inc.
Radiology · 134d
Cleared Oct 20, 2017
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
K171987 · KGO
Lucenxia Prescience AG
General Hospital · 109d
Cleared Oct 20, 2017
Adani MammoScan
K172027 · MUE
Adani
Radiology · 107d
Cleared Oct 20, 2017
GuideLiner V3 Catheter
K172090 · DQY
Vascular Solutions, Inc.
Cardiovascular · 101d
Cleared Oct 20, 2017
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non...
K172149 · GAP
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 95d