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
28225–28248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 2017
1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy...
K172386 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 16d
Cleared Aug 23, 2017
Passport Series Patient Monitors(Passport 12m, Passport 17m)
K170876 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 152d
Cleared Aug 23, 2017
LG BEAUTY LED MASK
K170984 · OHS
Lg Electronics
General & Plastic Surgery · 142d
Cleared Aug 23, 2017
Physiotrace
K171244 · DRX
Nimbleheart, Inc.
Cardiovascular · 117d
Cleared Aug 23, 2017
Ozark(tm) Cervical Plate System
K172104 · KWQ
K2m, Inc.
Orthopedic · 42d
Cleared Aug 23, 2017
Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
K172214 · NDN
G-21 S.R.L.
Orthopedic · 30d
Cleared Aug 23, 2017
Endoscopic Injection Needle
K172227 · FBK
Carbon Medical Technologies, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 23, 2017
EVOS Small Fragment Plating System
K172262 · HRS
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 22, 2017
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r)...
K162540 · KFF
Siemens Healthcare Diagnostics...
Hematology · 344d
Cleared Aug 22, 2017
i-STAT Hematocrit test with i-STAT Alinity System
K163342 · JPI
Abbott Laboratories
Hematology · 266d
Cleared Aug 22, 2017
Borrelia B31 ViraChip IgM Test Kit
K163695 · LSR
Viramed Biotech AG
Microbiology · 237d
Cleared Aug 22, 2017
GRAVITY™ Soft Tissue Repair System
K170642 · GAT
Wrightmedicaltechnologyinc
General & Plastic Surgery · 173d
Cleared Aug 22, 2017
NEOCERA Advanced Barrier Cream
K170911 · FRO
Exeltis USA Dermatology, LLC
General & Plastic Surgery · 147d
Cleared Aug 22, 2017
SilverSeal
K171041 · FRO
Alliqua Biomedical, Inc.
General & Plastic Surgery · 137d
Cleared Aug 22, 2017
Matrixx System
K171140 · ODP
Nexxt Spine, LLC
Orthopedic · 126d
Cleared Aug 22, 2017
VERIFY Assert VH2O2 Self-Contained Biological Indicator
K171504 · FRC
STERIS Corporation
General Hospital · 91d
Cleared Aug 22, 2017
Monopolar Single Use Laparoscopic Instrument
K171523 · GEI
Getsch+Hiller Medizintechnik GmbH
General & Plastic Surgery · 89d
Cleared Aug 22, 2017
VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
K171587 · FRC
STERIS Corporation
General Hospital · 83d
Cleared Aug 22, 2017
OKI Surgical Planning Software
K171617 · LLZ
Ortho Kinematics, Inc.
Radiology · 82d
Cleared Aug 22, 2017
Grivamax Hair Growth System
K171895 · OAP
Leana Orders, Inc.
General & Plastic Surgery · 57d
Cleared Aug 22, 2017
EzDent-i / E2 / Prora View
K172364 · LLZ
Ewoosoft Co., Ltd.
Radiology · 18d
Cleared Aug 22, 2017
Stryker Integrated Bipolar Cord and Tubing Sets
K172367 · GEI
Stryker Instruments
General & Plastic Surgery · 18d
Cleared Aug 21, 2017
INFINITY™ OCT System
K163375 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 263d
Cleared Aug 21, 2017
ShockPulse-SE Lithotripsy System
K171024 · FEO
Cybersonics, Inc.
Gastroenterology & Urology · 138d