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
15625–15648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2021
ANNE One
K211305 · DRG
Sibel, Inc.
Cardiovascular · 138d
Cleared Sep 14, 2021
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0,...
K211389 · OBP
Magstim Company, Ltd.
Neurology · 132d
Cleared Sep 14, 2021
Nitta M&T Safety Box
K211464 · MMK
Nitta M&T (Thailand) Co., Ltd.
General Hospital · 126d
Cleared Sep 14, 2021
Kleiner KG2 System
K211474 · MAX
BAAT Medical Products B.V.
Orthopedic · 125d
Cleared Sep 14, 2021
Polaris X Unidirectional Steerable Diagnostic Catheter
K211494 · DRF
Boston Scientific Corporation
Cardiovascular · 124d
Cleared Sep 14, 2021
Rotarex Atherectomy System
K211738 · MCW
C.R. Bard, Inc.
Cardiovascular · 99d
Cleared Sep 14, 2021
PHOENIX
K212291 · IZL
Sedecal., Sa.
Radiology · 54d
Cleared Sep 14, 2021
Viveve System, Viveve 2.0 System
K212678 · GEI
Viveve Medical, Inc.
General & Plastic Surgery · 21d
Cleared Sep 13, 2021
EDEN Peek Cage
K201793 · ODP
Jmt Co., Ltd.
Orthopedic · 440d
Cleared Sep 13, 2021
EliA Rib-P
K202540 · MQA
Phadia AB
Immunology · 376d
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