FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13417–13440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2022
Rapid LVO
K221248 · QAS
Ischemaview, Inc.
Radiology · 29d
Cleared May 31, 2022
EchoNavigator R4.0
K221270 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared May 31, 2022
Liverty™ TIPS Access Set
K221440 · DYB
Bard Peripheral Vascular, Inc.
Cardiovascular · 14d
Cleared May 28, 2022
Blue Nitrile Examination Gloves Powder Free
K212584 · LZA
Amazing Rubber Products Pvt, Ltd.
General Hospital · 285d
Cleared May 28, 2022
Amazing+ Latex Examination Powder Free Gloves
K212597 · LYY
Amazing Rubber Products Pvt, Ltd.
General Hospital · 285d
Cleared May 28, 2022
Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors,...
K213141 · LZA
Shen Wei (Usa), Inc.
General Hospital · 243d
Cleared May 27, 2022
FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
K212268 · DQX
FMD Co., Ltd.
Cardiovascular · 311d
Cleared May 27, 2022
Single Use Hemoclip
K212669 · PKL
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 277d
Cleared May 27, 2022
Benchmark Intracranial Access System
K212838 · QJP
Penumbra, Inc.
Neurology · 262d
Cleared May 27, 2022
Aspire Cristalle
K212873 · MUE
Fujifilm Corporation
Radiology · 260d
Cleared May 27, 2022
CoLink PCR Plating System
K213698 · HRS
In2bones USA, LLC
Orthopedic · 185d
Cleared May 27, 2022
VisAR
K220146 · OLO
Novarad Corporation
Orthopedic · 128d
Cleared May 27, 2022
MoistureMeterD Compact, LymphScanner
K220557 · OBH
Delfin Technologies, Ltd.
Gastroenterology & Urology · 88d
Cleared May 27, 2022
Spine Guidance Software, Stryker Q Guidance System
K220593 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 87d
Cleared May 27, 2022
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs...
K220609 · LZA
Encompass Industries Sdn. Bhd.
General Hospital · 86d
Cleared May 27, 2022
SOLO-L
K220610 · OVD
Aurora Spine, Inc.
Orthopedic · 85d
Cleared May 27, 2022
Senhance Surgical System
K220889 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 60d
Cleared May 27, 2022
Navagio Lumbar Cage
K220902 · MAX
Kalitec Medical, LLC
Orthopedic · 60d
Cleared May 26, 2022
Amylase2
K210633 · JFJ
Abbott Ireland Diagnostics Division
Chemistry · 449d
Cleared May 26, 2022
ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital...
K211779 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 351d
Cleared May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K212132 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 322d
Cleared May 26, 2022
I-Motion
K212413 · NGX
I-Motion Group Global Iberica S.L.
Physical Medicine · 296d
Cleared May 26, 2022
PP Care Nitrile Examination Gloves
K212629 · LZA
Eg Group Product and Services Co., Ltd.
General Hospital · 280d
Cleared May 26, 2022
Aura Storm
K212644 · FRA
Invictus Lighting
General Hospital · 279d