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
16225–16248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2021
EliA RNA Pol III
K202541 · NYO
Phadia AB
Immunology · 376d
Cleared Sep 13, 2021
Disposable Medical Mask
K203455 · FXX
Fujian Kang Chen Daily Necessities...
General Hospital · 294d
Cleared Sep 13, 2021
Harmony Referral System
K210396 · NFJ
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 215d
Cleared Sep 13, 2021
CIV-Clear cover
K211270 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 139d
Cleared Sep 13, 2021
HandX
K212214 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 60d
Cleared Sep 13, 2021
IRIS-XP
K212412 · LHQ
Medicore Co., Ltd.
Radiology · 41d
Cleared Sep 13, 2021
KONICAMINOLTA DI-X1
K212685 · LLZ
Konica Minolta, Inc.
Radiology · 20d
Cleared Sep 11, 2021
Surgical face mask
K211296 · FXX
Sunsmed Protective Products , Ltd.
General Hospital · 136d
Cleared Sep 10, 2021
Kinepict Medical Imaging Tool 4.0
K202056 · LLZ
Kinepict Health, Ltd.
Radiology · 413d
Cleared Sep 10, 2021
ClariSIGMAM
K203785 · QIH
Claripi, Inc.
Radiology · 256d
Cleared Sep 10, 2021
AccuFFRangio
K210093 · QHA
ArteryFlow Technology Co., Ltd.
Radiology · 239d
Cleared Sep 10, 2021
AlertWatch:AC
K210160 · MSX
Alertwatch, Inc.
Cardiovascular · 232d
Cleared Sep 10, 2021
Sterile syringe for single use with/without needle
K210227 · FMF
Zhejiang Kangkang Medical-Devices...
General Hospital · 225d
Cleared Sep 10, 2021
s-Clean Pre-Milled Abutment Mini
K210410 · NHA
Dentis Co., Ltd.
Dental · 211d
Cleared Sep 10, 2021
Versana Premier
K210438 · IYN
GE Medical Systems Ultrasound and...
Radiology · 210d
Cleared Sep 10, 2021
JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
K210625 · ODC
Fujifilm Medwork GmbH
Gastroenterology & Urology · 192d
Cleared Sep 10, 2021
EFAI PACS Picture Archiving and Communication System
K211257 · LLZ
Ever Fortune.Ai, Co., Ltd.
Radiology · 137d
Cleared Sep 10, 2021
Iovera System
K211334 · GXH
Pacira Pharmaceuticals, Inc.
Neurology · 130d
Cleared Sep 10, 2021
Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
K211375 · DRF
Boston Scientific Corporation
Cardiovascular · 129d
Cleared Sep 10, 2021
LOGIQ E10
K211488 · IYN
Ge Healthcare
Radiology · 120d
Cleared Sep 10, 2021
Aquilion Exceed LB
K211828 · JAK
Canon Medical Systems Corporation
Radiology · 88d
Cleared Sep 10, 2021
gammaCore Sapphire
K211856 · PKR
Electrocore, Inc.
Neurology · 86d
Cleared Sep 10, 2021
Surgical Mask
K212451 · FXX
Remade USA, LLC
General Hospital · 36d
Cleared Sep 10, 2021
Explorer TO System
K212540 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 29d