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
10537–10560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2023
SAVE GBR
K222367 · DZL
Dentis Co., Ltd.
Dental · 230d
Cleared Mar 23, 2023
Fixone All Suture Anchor
K222423 · MBI
Aju Pharm Co., Ltd.
Orthopedic · 224d
Cleared Mar 23, 2023
Sterilized Latex Surgical Gloves
K222620 · KGO
Suzhou Colour-Way New Material Co., Ltd.
General Hospital · 205d
Cleared Mar 23, 2023
3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and...
K222859 · OMP
3M
General & Plastic Surgery · 182d
Cleared Mar 23, 2023
Triever16 Curve
K223419 · QEW
Inari Medical
Cardiovascular · 133d
Cleared Mar 23, 2023
SpaceFlex Acetabular Cup
K223441 · KWY
G21, S.R.L.
Orthopedic · 129d
Cleared Mar 23, 2023
ClosureFast™ Endovenous Radiofrequency Ablation Catheter
K223488 · GEI
Medtronic, Inc.
General & Plastic Surgery · 122d
Cleared Mar 23, 2023
ATEC Lateral Navigation Instruments
K223765 · OLO
Alphatec Spine, Inc.
Orthopedic · 98d
Cleared Mar 23, 2023
Disposable Medical Nitrile Examination Gloves
K223895 · LZA
Hebei Titans Hongsen Medical...
General Hospital · 85d
Cleared Mar 23, 2023
Swedge™ Pedicle Screw Fixation System
K230482 · NKB
Spinal Resources, Inc.
Orthopedic · 29d
Cleared Mar 22, 2023
BioFire Global Fever Special Pathogens Panel
K213362 · QVR
Biofire Defense, LLC
Microbiology · 526d
Cleared Mar 22, 2023
Tigon Medical Gryphon Anchor Line
K220464 · MBI
Tigon Medical
Orthopedic · 398d
Cleared Mar 22, 2023
CEREC Tessera Abutment Block, CEREC Tessera Abutment System
K221402 · NHA
Dentsply Sirona, Inc.
Dental · 310d
Cleared Mar 22, 2023
MPXA-2000
K222036 · QIH
Medipixel, Inc.
Radiology · 254d
Cleared Mar 22, 2023
CardioSTAT® ECG Test Solution
K223049 · DSH
Icentia, Inc.
Cardiovascular · 174d
Cleared Mar 22, 2023
Ceribell Instant EEG Headcap
K223086 · GXY
Ceribell, Inc.
Neurology · 173d
Cleared Mar 22, 2023
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
K223593 · GCJ
Taiwan Surgical Corporation
General & Plastic Surgery · 111d
Cleared Mar 22, 2023
POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular...
K223824 · DRA
Boston Scientific Corporation
Cardiovascular · 91d
Cleared Mar 22, 2023
SPIRA®-C Integrated Fixation System
K223837 · OVE
Camber Spine Technologies
Orthopedic · 90d
Cleared Mar 22, 2023
Stativ® Knotted UHMWPE Suture Anchor
K223889 · MBI
Healthium Medtech Limited
Orthopedic · 85d
Cleared Mar 22, 2023
Epi-Stop Nasal Gel/epistaxis pack
K230142 · LYA
Biomed Ent, Inc.
Ear, Nose, Throat · 63d
Cleared Mar 22, 2023
Arise™ UHP Dilatation Catheter
K230191 · LIT
Creagh Medical, Ltd.
Cardiovascular · 57d
Cleared Mar 22, 2023
HF Surgery Generator 400KHZ
K230194 · GEI
Richard Wolf Medical Instruments...
General & Plastic Surgery · 57d
Cleared Mar 22, 2023
Motive™ Electrode
K230533 · GXY
Cymedica Orthopedics, Inc.
Neurology · 23d