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
28993–29016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 2017
AcceleDent Optima
K170093 · OYH
Orthoaccel Technology, Inc.
Dental · 135d
Cleared May 26, 2017
FFR V2.5
K170133 · IYO
Philips Volcano
Radiology · 129d
Cleared May 26, 2017
Ultravision Visual Field Clearing System
K170178 · PQM
Alesi Surgical, Ltd.
General Hospital · 127d
Cleared May 26, 2017
Flexitouch System
K170216 · JOW
Tactile Systems Technology, Inc. (Dba...
Cardiovascular · 122d
Cleared May 26, 2017
IQ Technologies
K170659 · NUH
Iq Technologies, Inc.
Neurology · 84d
Cleared May 26, 2017
Respire Pink Series with DentiTrac
K170692 · LRK
Respire Medical Holding
Dental · 80d
Cleared May 26, 2017
RAPID Web
K170839 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 66d
Cleared May 26, 2017
Nova StatSensor Creatinine Hospital Meter System
K171059 · CGL
Nova Biomedical Corporation
Chemistry · 46d
Cleared May 26, 2017
DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
K171217 · DXT
Osprey Medical, Inc.
Cardiovascular · 30d
Cleared May 26, 2017
DELL UP3017 with QUBYX PerfectLum bundle
K171229 · PGY
Qubyx Software Technologies, Inc.
Radiology · 29d
Cleared May 26, 2017
My Dose Coach
K171230 · NDC
Sanofi
General Hospital · 29d
Cleared May 26, 2017
Mistral-Air Warming Unit
K171234 · DWJ
The Surgical Company International BV...
Cardiovascular · 29d
Cleared May 26, 2017
da Vinci X Surgical System
K171294 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 24d
Cleared May 26, 2017
SutureTape
K171296 · GAT
Arthrex, Inc.
General & Plastic Surgery · 24d
Cleared May 25, 2017
MultiGen™ 2 RF Generator System
K170242 · GXD
Stryker Corporation
Neurology · 119d
Cleared May 25, 2017
TruAbutment DS
K170259 · NHA
Truabutment
Dental · 118d
Cleared May 25, 2017
CATHTONG II PICC Catheter
K170486 · LJS
L&Z Us, Inc.
General Hospital · 101d
Cleared May 25, 2017
GenePOC GBS LB
K170557 · NJR
Genepoc, Inc.
Microbiology · 90d
Cleared May 25, 2017
revogene
K170558 · OOI
Genepoc, Inc.
Microbiology · 90d
Cleared May 25, 2017
PicoWay Laser System
K170597 · GEX
Syneron Candela Corporation
General & Plastic Surgery · 86d
Cleared May 25, 2017
SETx Pedicle Screw System
K170611 · NKB
Xenco Medical, LLC
Orthopedic · 85d
Cleared May 25, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
K170892 · JWY
Liofilchem S. R. L.
Microbiology · 59d
Cleared May 25, 2017
LCD Monitor (MD310C, MD310G, MD210G)
K170944 · PGY
Benq Corporation
Radiology · 56d
Cleared May 25, 2017
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional...
K171170 · NKB
Medacta International S.A.
Orthopedic · 34d