FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
13153–13176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 26, 2022
Laser Hair Growth Comb
K213027 · OAP
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 247d
Cleared May 26, 2022
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta...
K213171 · HIH
Meditrina, Inc.
Obstetrics & Gynecology · 240d
Cleared May 26, 2022
AMADEO, M-UK1015 (incl. attachments and accessories)
K213221 · ERL
W&H Dentalwerk Buermoss GmbH
Dental · 239d
Cleared May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K213996 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 157d
Cleared May 26, 2022
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
K214074 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 150d
Cleared May 26, 2022
iFuse Bedrock Granite™ Implant System
K220195 · OUR
SI-BONE, Inc.
Orthopedic · 122d
Cleared May 26, 2022
Sterile Nitrile Powder Free Examination Gloves Tested For Use With...
K220249 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 115d
Cleared May 26, 2022
Astroglide Ultra Gentle Gel
K220355 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 107d
Cleared May 26, 2022
Powder Free Nitrile Examination Gloves, Blue, Tested for use with...
K220545 · LZC
Hl Rubber Industries Sdn Bhd
General Hospital · 90d
Cleared May 26, 2022
Wearable Breast Pump (Model S9)
K220596 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 86d
Cleared May 26, 2022
Disposable Surgical Face Mask (FM-34EE,FM-44EE)
K220597 · FXX
Qingdao Bestex Rubber & Plastic...
General Hospital · 86d