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
23017–23040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2019
iRestore Professional 282
K183417 · OAP
Freedom Laser Therapy, Inc.
General & Plastic Surgery · 158d
Cleared May 17, 2019
KY Banksy Moisture
K183505 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 150d
Cleared May 17, 2019
Revolution Radial Head
K183618 · KWI
Ignite Orthopedics, Inc.
Orthopedic · 142d
Cleared May 17, 2019
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
K190675 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 63d
Cleared May 17, 2019
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer...
K191015 · MQF
Cook Incorporated
Obstetrics & Gynecology · 30d
Cleared May 17, 2019
DRX-Revolution Mobile X-ray System
K191025 · IZL
Carestream Health, Inc.
Radiology · 29d
Cleared May 17, 2019
Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator...
K191029 · DTZ
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 16, 2019
Tel-O-Graph
K173895 · DXN
I.E.M. Industrielle Entwicklung and...
Cardiovascular · 511d
Cleared May 16, 2019
EVOLUTION NitrX Medial-Pivot Knee
K182251 · JWH
Mircoport Orthopedics, Inc.
Orthopedic · 269d
Cleared May 16, 2019
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily...
K182734 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 230d
Cleared May 16, 2019
Fully Automatic Electronic Blood Pressure Monitor
K183534 · DXN
Andon Health Co, Ltd.
Cardiovascular · 148d
Cleared May 16, 2019
VPC
K190345 · CAZ
PAJUNK GmbH Medizintechnologie
Anesthesiology · 91d
Cleared May 16, 2019
Precision Casting Solutions Total Knee System
K190355 · JWH
Precision Casting Solutions, Inc.
Orthopedic · 90d
Cleared May 16, 2019
Aveta System
K190372 · HIH
Meditrina, Inc.
Obstetrics & Gynecology · 90d
Cleared May 16, 2019
Aptima CV/TV Assay
K190472 · PQA
Hologic, Inc.
Microbiology · 79d
Cleared May 16, 2019
Carnation Ambulatory Monitor
K191000 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared May 16, 2019
Dolphin/IQ, Dolphin/4D and Dolphin/MAX
K191023 · IYN
Viasonix , Ltd.
Radiology · 29d
Cleared May 16, 2019
syngo.via (Version VB40A)
K191040 · LLZ
Siemens Healthcare GmbH
Radiology · 27d
Cleared May 16, 2019
ARGOS
K191051 · MXK
Santec Corporation
Ophthalmic · 27d
Cleared May 15, 2019
VeriClear Digital Early Result Pregnancy Test
K182328 · LCX
True Diagnostics, Inc.
Chemistry · 261d
Cleared May 15, 2019
Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife...
K182408 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 253d
Cleared May 15, 2019
Flexible Overtube
K182520 · FED
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology · 244d
Cleared May 15, 2019
Liba3 System
K182532 · DSI
National Cardiac, Inc.
Cardiovascular · 243d
Cleared May 15, 2019
SOFIA EX Intracranial Support Catheter
K182602 · DQY
MicroVention, Inc.
Neurology · 236d