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
20209–20232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2020
PGDx elio tissue complete
K192063 · PZM
Personal Genome Diagnostics
Pathology · 267d
Cleared Apr 24, 2020
Custodiol HTK Solution
K192408 · KDL
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 233d
Cleared Apr 24, 2020
MT One
K192856 · GEX
M&T S.R.L.
General & Plastic Surgery · 203d
Cleared Apr 24, 2020
GSI Audera Pro
K193033 · GWJ
Grason Stadler
Neurology · 176d
Cleared Apr 24, 2020
SPIRA-C Integrated Fixation System
K193153 · OVE
Camber Spine Technologies
Orthopedic · 163d
Cleared Apr 24, 2020
SeaSpine Reef TH System
K193636 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 119d
Cleared Apr 24, 2020
O-arm O2 Imaging System
K200074 · OWB
Medtronic, Inc.
Radiology · 101d
Cleared Apr 24, 2020
EXPEDIUM® Spine System
K200245 · NKB
Medos International S?rl
Orthopedic · 84d
Cleared Apr 24, 2020
Single Use Biopsy Forceps FB-456D
K200397 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 66d
Cleared Apr 24, 2020
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
K200826 · JWH
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Apr 23, 2020
U-Aligner
K191308 · NXC
Universal Orthodontic Laboratory, Inc.
Dental · 345d
Cleared Apr 23, 2020
RocaTub Ureteral Catheter
K192183 · EYB
Promepal Sam
Gastroenterology & Urology · 255d
Cleared Apr 23, 2020
MF SAFECATH
K192230 · FOZ
Medifirst Co., Ltd.
General Hospital · 251d
Cleared Apr 23, 2020
Pressure Therapy System PT1003
K192358 · IRP
Xiamen Senyang Co., Ltd.
Physical Medicine · 238d
Cleared Apr 23, 2020
NemoFAB
K192475 · LLZ
Software Nemotec S.L.
Dental · 226d
Cleared Apr 23, 2020
GM501 SpermAir and GM501 SpermActive
K192644 · MQL
Hamilton Thorne Incorporated
Obstetrics & Gynecology · 212d
Cleared Apr 23, 2020
Duo-Flow Side x Side Double Lumen Catheter
K192807 · MPB
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 205d
Cleared Apr 23, 2020
DynaClip Bone Staple
K193305 · JDR
MedShape, Inc.
Orthopedic · 146d
Cleared Apr 23, 2020
ARx Spinal System
K200070 · NKB
Life Spine, Inc.
Orthopedic · 101d
Cleared Apr 23, 2020
QuikClot Control+
K200167 · POD
Z-Medica, LLC
General & Plastic Surgery · 91d
Cleared Apr 23, 2020
Biomonitor III, Biomonitor IIIm
K200444 · MXD
Biotronik, Inc.
Cardiovascular · 59d
Cleared Apr 23, 2020
Stryker Xia 3 Power Adaptor
K200666 · NKB
Stryker Spine
Orthopedic · 41d
Cleared Apr 23, 2020
Nurochek System
K200705 · GWE
Cryptych Pty, Ltd.
Neurology · 36d
Cleared Apr 23, 2020
CoLink Cfx Plating System
K200762 · HRS
In2bones USA, LLC
Orthopedic · 30d