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
23881–23904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2019
Pre-Formed Penile Silicone Block
K181387 · MIB
International Medical Devices, Inc.
General & Plastic Surgery · 243d
Cleared Jan 23, 2019
Masimo MightySat Rx Fingertip Pulse Oximeter
K181956 · DQA
Masimo Corporation
Anesthesiology · 184d
Cleared Jan 23, 2019
SPY Elite Intraoperative Perfusion Assessment System
K182907 · IZI
Novadaq Technologies Ulc. (Now A Part...
General & Plastic Surgery · 98d
Cleared Jan 23, 2019
Optilite IgA CSF Kit
K183151 · CFN
The Binding Site Group , Ltd.
Immunology · 70d
Cleared Jan 22, 2019
FEMON Banana Thermometer
K180767 · FLL
Life Science Technology, Inc.
General Hospital · 305d
Cleared Jan 22, 2019
AMD Anti-Fog Solution
K181887 · OCT
Advanced Medical Design Co., Ltd.
Gastroenterology & Urology · 193d
Cleared Jan 22, 2019
S-Line
K182193 · NJM
Biocetec Co., Ltd.
Dental · 161d
Cleared Jan 22, 2019
Freedom Ultra-Congruent CR Tibial Liner
K182574 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 126d
Cleared Jan 22, 2019
M.U.S.T. Mini Extension
K182837 · NKG
Medacta International S.A.
Orthopedic · 105d
Cleared Jan 22, 2019
HM70A Diagnostic Ultrasound System
K182894 · IYN
Samsung Medison Co., Ltd.
Radiology · 99d
Cleared Jan 22, 2019
EZStart Interference Screw
K182955 · HWC
Conmed Corporation
Orthopedic · 90d
Cleared Jan 22, 2019
EUROPA™ Pedicle Screw System
K182970 · NKB
MiRus, LLC
Orthopedic · 88d
Cleared Jan 22, 2019
Compress and Mini Compress Anti-Rotation Spindles
K183553 · MBF
Biomet, Inc.
Orthopedic · 33d
Cleared Jan 22, 2019
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery...
K183636 · FBN
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Jan 22, 2019
LG PRA.L DERMA LED MASK
K183671 · OHS
Lg Electronics.Inc
General & Plastic Surgery · 26d
Cleared Jan 22, 2019
O-Scan
K183685 · LNH
Esaote, S.P.A.
Radiology · 25d
Cleared Jan 21, 2019
Tigon Medical Tissue Anchors
K182507 · MBI
Tigon Medical
Orthopedic · 131d
Cleared Jan 21, 2019
XableCath Crossing Catheter
K183357 · PDU
Xablecath, Inc.
Cardiovascular · 48d
Cleared Jan 20, 2019
Codman Disposable Perforators
K183581 · HBF
Integra Lifesciences Corp.
Neurology · 30d
Cleared Jan 19, 2019
ELAN 4 Tools
K182527 · HBE
Aesculap, Inc.
Neurology · 127d
Cleared Jan 18, 2019
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
K180236 · FPD
Vr Medical Technology Co., Ltd.
Gastroenterology & Urology · 354d
Cleared Jan 18, 2019
Responsive Arthroscopy Wedge Push-In Suture Anchors
K181076 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 269d
Cleared Jan 18, 2019
PENTAX Video Colonoscopes (EC Family)
K181084 · FDF
Pentax of America, Inc.
Gastroenterology & Urology · 269d
Cleared Jan 18, 2019
Cook Cystostomy Catheter Set
K181097 · KOB
Cook Incorporated
Gastroenterology & Urology · 267d