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
22705–22728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2019
SwimCount Sperm Quality Test
K183602 · POV
Motilitycount Aps
Hematology · 183d
Cleared Jun 27, 2019
LiverMultiScan (LMSv3)
K190017 · LNH
Perspectum Diagnostics, Ltd.
Radiology · 175d
Cleared Jun 27, 2019
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs...
K190080 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 162d
Cleared Jun 27, 2019
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition...
K190578 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Jun 27, 2019
DynaFlex
K190583 · NXC
Dyna Flex
Dental · 113d
Cleared Jun 27, 2019
FlexGard Cut-Resistant Glove Liners
K190782 · KGO
Ldi Corporation
General Hospital · 92d
Cleared Jun 27, 2019
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
K191175 · OBJ
Acist Medical Systems, Inc.
Cardiovascular · 57d
Cleared Jun 27, 2019
ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
K191438 · OCX
Erbe USA, Inc.
Gastroenterology & Urology · 28d
Cleared Jun 27, 2019
Human IgM Kit for use on SPAPlus
K191465 · CFN
The Binding Site Group , Ltd.
Immunology · 24d
Cleared Jun 26, 2019
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
K182832 · KGC
Cook Incorporated
Gastroenterology & Urology · 260d
Cleared Jun 26, 2019
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with...
K182851 · LZA
O&M Halyard, Inc.
General Hospital · 259d
Cleared Jun 26, 2019
R2GATE
K190096 · LLZ
Megagen Implant Co., Ltd.
Radiology · 155d
Cleared Jun 26, 2019
Straumann CARES Screw-Retained Bridges and Bars
K190097 · NHA
Institut Straumann AG
Dental · 155d
Cleared Jun 26, 2019
Elos Accurate® Customized Abutment
K190299 · NHA
Elos Medtech Pinol A/S
Dental · 135d
Cleared Jun 26, 2019
Phototherapy System
K190938 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 77d
Cleared Jun 26, 2019
Vantage Titan 3T, MRT-3010, V2.5
K191128 · LNH
Canon Medical Systems Corporation
Radiology · 58d
Cleared Jun 26, 2019
DigniCap Delta
K191166 · PMC
Dignitana, Inc.
General & Plastic Surgery · 56d
Cleared Jun 26, 2019
Deflectable Brush Biopsy Set
K191485 · FDX
Cook Incorporated
Gastroenterology & Urology · 22d
Cleared Jun 25, 2019
WishBone Guided Growth System
K182704 · OBT
Wishbone Medical
Orthopedic · 271d
Cleared Jun 25, 2019
Radio Frequency Ablation System
K190052 · GEI
Surgnova Healthcare Technologies...
General & Plastic Surgery · 165d
Cleared Jun 25, 2019
Venus Bliss
K190743 · PBX
Venus Concept USA, Inc.
General & Plastic Surgery · 95d
Cleared Jun 25, 2019
Trevo XP ProVue Retriever
K190779 · POL
Stryker
Neurology · 90d
Cleared Jun 25, 2019
BUHLMANN fCAL turbo
K190784 · NXO
Buhlmann Laboratories AG
Immunology · 90d
Cleared Jun 25, 2019
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
K190785 · NLG
Innovative Health, LLC
Cardiovascular · 90d