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
27217–27240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2017
Prodigio Stain Powder
K171167 · EIH
Operart, LLC
Dental · 236d
Cleared Dec 13, 2017
Adhesive Electrodes
K171381 · GXY
Shenzhen Quality Medical Technology...
Neurology · 216d
Cleared Dec 13, 2017
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose...
K171480 · NBW
I-Sens, Inc.
Chemistry · 208d
Cleared Dec 13, 2017
Fixtemp C&B
K171729 · EBG
Dreve Dentamid GmbH
Dental · 184d
Cleared Dec 13, 2017
eVox System
K171781 · GWQ
Evoke Neuroscience, Inc.
Neurology · 181d
Cleared Dec 13, 2017
Arthrex DynaNite Nitinol Staple
K172052 · JDR
Arthrex, Inc.
Orthopedic · 160d
Cleared Dec 13, 2017
InnoSight Diagnostic Ultrasound System
K172056 · IYO
Qisda Corporation
Radiology · 160d
Cleared Dec 13, 2017
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral...
K172217 · FED
Cook Incorporated
Gastroenterology & Urology · 142d
Cleared Dec 13, 2017
FMP Extended Liners
K172651 · OQG
Encore Medical, L.P.
Orthopedic · 99d
Cleared Dec 13, 2017
Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic)...
K172692 · LPL
Tangible Science, LLC
Ophthalmic · 98d
Cleared Dec 13, 2017
True Flow Valvuloplasty Perfusion Catheter
K172932 · OZT
C.R. Bard, Inc.
Cardiovascular · 78d
Cleared Dec 13, 2017
2940 nm Er:Yag Laser Handpiece
K173002 · GEX
Quanta System Spa
General & Plastic Surgery · 77d
Cleared Dec 13, 2017
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
K173369 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 47d
Cleared Dec 13, 2017
TSV BellaTek Encode Healing Abutments
K173374 · NHA
Biomet 3i
Dental · 47d
Cleared Dec 13, 2017
Neurosoft TMS (also CloudTMS)
K173441 · OBP
Teleemg, LLC
Neurology · 37d
Cleared Dec 13, 2017
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza...
K173502 · PSZ
Alere Scarborough, Inc.
Microbiology · 30d
Cleared Dec 13, 2017
ANAX 5.5™ Spinal System
K173524 · NKB
U&I Corporation
Orthopedic · 29d
Cleared Dec 13, 2017
Advocate PTA Catheter
K173621 · LIT
Merit Medical Systems, Inc.
Cardiovascular · 21d
Cleared Dec 12, 2017
Disposable High Pressure Syringe
K170279 · DXT
Union Medical Shenzhen Co., Ltd.
Cardiovascular · 316d
Cleared Dec 12, 2017
Wittich Nitinol Stone Basket
K170898 · LQR
Cook Incorporated
Gastroenterology & Urology · 260d
Cleared Dec 12, 2017
DropSafe Safety Pen Needle
K170988 · FMI
Htl-Strefa S.A
General Hospital · 253d
Cleared Dec 12, 2017
Sterile Endoscope Biopsy Sampling Needle
K171956 · FCG
Changzhou Detain Medical Devices Co.,...
Gastroenterology & Urology · 166d
Cleared Dec 12, 2017
Xario 200 Diagnostic Ultrasound System V6.0
K172276 · IYN
Toshibamedical Systems Corporation
Radiology · 137d
Cleared Dec 12, 2017
SporView Rapid Read Biological Indicator
K172432 · FRC
Crosstex/Spsmedical, A Division of...
General Hospital · 123d