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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13369–13392 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 2022
Non-sterile, Powder-Free Latex Examination Glove
K212309 · LYY
Sri Trang Gloves (Thailand) Public...
General Hospital · 259d
Cleared Apr 08, 2022
Fitbit Irregular Rhythm Notifications
K212372 · QDB
Fitbit, Inc.
Cardiovascular · 252d
Cleared Apr 08, 2022
SCOUT BX Delivery System
K212882 · NEU
Merit Medical Systems, Inc.
General & Plastic Surgery · 210d
Cleared Apr 08, 2022
DORA Disposable A.V. Fistula Needle Sets
K213015 · FIE
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 200d
Cleared Apr 08, 2022
TLX SRAs and TLX Gold Abutments
K213063 · NHA
Institut Straumann AG
Dental · 197d
Cleared Apr 08, 2022
Latex Examination Gloves, Powder Free
K213509 · LYY
Shandong Intco Medical Products Co, Ltd.
General Hospital · 157d
Cleared Apr 08, 2022
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
K213633 · GAG
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 142d
Cleared Apr 08, 2022
Bioabsorbable Anchor
K213958 · MAI
Embody, Inc.
Orthopedic · 112d
Cleared Apr 08, 2022
Breast BI Coil Set 0.55T
K220144 · MOS
Noras Mri Products GmbH
Radiology · 79d
Cleared Apr 08, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K220192 · LNH
Canon Medical Systems Corporation
Radiology · 74d
Cleared Apr 08, 2022
ImaCor Zura Handheld ZHH-010
K220490 · IYN
Imacor, Inc.
Radiology · 45d
Cleared Apr 08, 2022
Prestige Coil System
K220699 · KRD
Bait USA, LLC
Cardiovascular · 29d
Cleared Apr 08, 2022
CD Horizon™ Spinal System and PASS LP™ Spinal System
K220724 · NKB
Medicrea International
Orthopedic · 25d
Cleared Apr 08, 2022
Drive Rail System
K220809 · KTT
OrthoPediatrics Corp.
Orthopedic · 18d
Cleared Apr 07, 2022
Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
K210860 · FXX
Gri-Alleset, Inc.
General Hospital · 380d
Cleared Apr 07, 2022
Green OR Reprocessed Aquamantys Bipolar Sealer
K211203 · NUJ
Green Or, LLC
General & Plastic Surgery · 350d
Cleared Apr 07, 2022
Corin MetaFix™ Hip Stem
K212069 · LZO
Corin U.S.A. Limited
Orthopedic · 279d
Cleared Apr 07, 2022
Dong Hai Xiang Surgical Mask
K212203 · FXX
Taizhou Donghaixiang Protective...
General Hospital · 267d
Cleared Apr 07, 2022
Electrocardiograph
K212278 · DPS
Edan Instruments, Inc.
Cardiovascular · 261d
Cleared Apr 07, 2022
Invisalign System
K220287 · NXC
Align Technology, Inc.
Dental · 65d
Cleared Apr 06, 2022
Plasmage System
K202106 · GEI
Brera Medical, Inc.
General & Plastic Surgery · 616d
Cleared Apr 06, 2022
MTM301 Blood Glucose and Ketone Monitoring System
K202534 · NBW
Apex BioTechnology Corp.
Chemistry · 582d
Cleared Apr 06, 2022
ClariPulmo
K203783 · LLZ
Claripi, Inc.
Radiology · 464d
Cleared Apr 06, 2022
Onera Sleep Test System (Onera STS)
K210593 · MNR
Onera B.V.
Neurology · 401d