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
24961–24984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2018
TENS device-HeadaTerm, eEspress
K172450 · PCC
Wat Medical Technology (Ningbo) Co.,...
Neurology · 395d
Cleared Sep 13, 2018
Sorrento Bioglass Bone Graft Substitute
K173933 · MQV
Xenco Medical, LLC
Orthopedic · 261d
Cleared Sep 13, 2018
Sof-Flex Ureteral Stent Set
K180053 · FAD
Cook Incorporated
Gastroenterology & Urology · 248d
Cleared Sep 13, 2018
DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
K180215 · OVD
Life Spine, Inc.
Orthopedic · 231d
Cleared Sep 13, 2018
SelectFlex 072 Neurovascular Access System
K181000 · DQY
Q'Apel
Neurology · 150d
Cleared Sep 13, 2018
HySil Impression Materials
K181236 · ELW
Osstem Implant Co., Ltd.
Dental · 126d
Cleared Sep 13, 2018
KLS Martin Individual Patient Solutions (IPS) Planning System
K181241 · DZJ
KLS-Martin L.P.
Dental · 126d
Cleared Sep 13, 2018
Planmeca Viso
K181576 · OAS
Planmeca Oy
Radiology · 90d
Cleared CT Sep 13, 2018
Spectralis HRA+OCT and variants with OCT Angiography Module
K181594 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 87d
Cleared Sep 13, 2018
MOSS VRS Spinal System
K181821 · NKB
Biedermann Motech GmbH & Co. KG
Orthopedic · 66d
Cleared Sep 13, 2018
MTS Penicillin 0.002- 32 µg/mL
K181889 · JWY
Liofilchem S. R. L.
Microbiology · 62d
Cleared Sep 13, 2018
RiX70 DC
K182206 · EHD
Trident S.R.L
Radiology · 29d
Cleared Sep 13, 2018
Seal Single Use Biopsy Valve
K182275 · OCX
Boston Scientific Corporation
Gastroenterology & Urology · 22d
Cleared Sep 12, 2018
BioSphere Flex
K173424 · MQV
Synergy Biomedical
Orthopedic · 315d
Cleared Sep 12, 2018
PRODENSE Bone Graft Substitute
K181255 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 124d
Cleared Sep 12, 2018
Magnesium
K181748 · JGJ
Abbott Laboratories
Chemistry · 72d
Cleared Sep 11, 2018
TruBase S
K171532 · NHA
Truabutment, Inc.
Dental · 474d
Cleared Sep 11, 2018
Anchor Tissue Retrieval System by CONMED
K173822 · GCJ
Conmed Corporation
Obstetrics & Gynecology · 267d
Cleared Sep 11, 2018
LnK Lumbar Interbody Fusion Cage System
K181380 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 110d
Cleared Sep 11, 2018
Stryker Pediatric Mandibular Distractor 2
K181504 · MQN
Stryker
Dental · 96d
Cleared Sep 11, 2018
IPL Salon Hair Reduction System
K181568 · OHT
Medical Device Branch of Zhangzhou...
General & Plastic Surgery · 89d
Cleared Sep 11, 2018
Renovis S180 Lateral Lumbar Interbody Fusion System
K181655 · MAX
Renovis Surgical Technologies
Orthopedic · 81d
Cleared Sep 11, 2018
Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope...
K182196 · DQD
Imediplus, Inc.
Cardiovascular · 28d
Cleared Sep 11, 2018
AirStrip RPM InvisionHeart Adapter
K182226 · MWI
Airstrip Technologies, Inc.
Cardiovascular · 26d