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
12769–12792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2022
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS...
K213899 · LON
bioMerieux, Inc.
Microbiology · 210d
Cleared Jul 12, 2022
Protrieve Sheath
K220415 · QEW
Inari Medical, Inc.
Cardiovascular · 148d
Cleared Jul 12, 2022
NAEOTOM Alpha, Scan&GO Software
K220814 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Jul 12, 2022
Smartlux Mini
K221083 · GEX
Medmix Co., Ltd.
General & Plastic Surgery · 90d
Cleared Jul 12, 2022
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software,...
K221098 · PGW
Stryker Corporation
Ear, Nose, Throat · 89d
Cleared Jul 12, 2022
Nitrile Medical Examination Gloves
K221108 · LZA
Anhui Fulewei Electronic Technology...
General Hospital · 88d
Cleared Jul 12, 2022
Disposable Medical Nitrile Examination Gloves - Non Sterile
K221454 · LZA
Guangzhou Kangling Biotechnology Co.,...
General Hospital · 54d
Cleared Jul 11, 2022
ANNE Sleep
K220095 · MNR
Sibel, Inc.
Anesthesiology · 180d
Cleared Jul 11, 2022
Revogene
K220480 · OOI
Meridian Bioscience, Inc.
Microbiology · 143d
Cleared Jul 11, 2022
DolorClast Radial
K220538 · ISA
E.M.S Electro Medical Systems S.A
Physical Medicine · 136d
Cleared Jul 11, 2022
Mitek TIGHT-N Anchor
K221364 · MBI
Medos International SARL
Orthopedic · 61d
Cleared Jul 11, 2022
Artix Ballon Guiding Sheath
K221846 · DQY
Inari Medical
Cardiovascular · 17d
Cleared Jul 10, 2022
MINE ALNU (Model: Mine 2.1)
K213405 · IZL
Hdt Co., Ltd.
Radiology · 264d
Cleared Jul 09, 2022
Noodle
K220573 · NUH
Pourang Bral, Dds, LLC
Neurology · 131d
Cleared Jul 08, 2022
ROTEM sigma Thromboelastometry System
K201440 · JPA
Tem Innovations GmbH
Hematology · 767d
Cleared Jul 08, 2022
KLS Martin IPS Preprosthetic
K210228 · ELE
KLS-Martin L.P.
Dental · 526d
Cleared Jul 08, 2022
VIDAS NEPHROCHECK
K210793 · PIG
Biom?rieux SA
Chemistry · 479d
Cleared Jul 08, 2022
Adin Short Implants
K212775 · DZE
Adin Dental Implants Systems , Ltd.
Dental · 310d
Cleared Jul 08, 2022
ProstatID
K212783 · QDQ
Scanmed, LLC
Radiology · 310d
Cleared Jul 08, 2022
Transcranial Doppler Ultrasound System
K213009 · IYN
Shenzhen Delica Medical Equipment...
Radiology · 291d
Cleared Jul 08, 2022
Single-Use Video Bronchoscopes, Digital Controller
K213782 · EOQ
Micro-Tech (Nanjing) Co., Lts
Ear, Nose, Throat · 217d
Cleared Jul 08, 2022
Powder Free Nitrile Examination Gloves (Blue)
K220284 · LZA
Kgm Gloves Sdn. Bhd.
General Hospital · 157d
Cleared Jul 08, 2022
Through the Scope Tracheal Stent System
K220424 · JCT
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology · 144d
Cleared Jul 08, 2022
DropSafe Acti-Lance Safety Lancets
K220643 · FMK
Htl-Strefa S.A
General & Plastic Surgery · 126d