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
11401–11424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2023
Fixone All Suture Anchor
K222423 · MBI
Aju Pharm Co., Ltd.
Orthopedic · 224d
Cleared Mar 23, 2023
SAVE GBR
K222367 · DZL
Dentis Co., Ltd.
Dental · 230d
Cleared Mar 23, 2023
MeMed BV
K222332 · QPS
MeMed Diagnostics, Ltd.
Microbiology · 233d
Cleared Mar 23, 2023
Sterilization Wrap
K222151 · FRG
Kenpax International Limited
General Hospital · 246d
Cleared Mar 23, 2023
RESPONSE 5.5/6.0 Cannulated Screw System
K222105 · NKB
OrthoPediatrics Corp.
Orthopedic · 248d
Cleared Mar 23, 2023
Endo Ultrasonic Activator
K222096 · ELC
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 248d
Cleared Mar 23, 2023
AccurSound Electronic Stethoscope AS-101
K221805 · DQD
Heroic Faith International , Ltd.
Cardiovascular · 274d
Cleared Mar 23, 2023
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice...
K221585 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 295d
Cleared Mar 23, 2023
Implant-One Multi-Unit Abutment
K212394 · NHA
Implant Logistics, Inc.
Dental · 598d
Cleared Mar 23, 2023
Sterile Hypodermic Syringe for Single Use
K212207 · FMF
Shandong Weigao Group Medical Polymer...
General Hospital · 616d
Cleared Mar 23, 2023
VHT-200 Wound Treatment System
K212121 · KPJ
Vaporox, Inc.
General & Plastic Surgery · 624d
Cleared Mar 22, 2023
Tryptik Ti
K230583 · ODP
Spineart SA
Orthopedic · 20d
Cleared Mar 22, 2023
Motive™ Electrode
K230533 · GXY
Cymedica Orthopedics, Inc.
Neurology · 23d
Cleared Mar 22, 2023
HF Surgery Generator 400KHZ
K230194 · GEI
Richard Wolf Medical Instruments...
General & Plastic Surgery · 57d
Cleared Mar 22, 2023
Arise™ UHP Dilatation Catheter
K230191 · LIT
Creagh Medical, Ltd.
Cardiovascular · 57d
Cleared Mar 22, 2023
Epi-Stop Nasal Gel/epistaxis pack
K230142 · LYA
Biomed Ent, Inc.
Ear, Nose, Throat · 63d
Cleared Mar 22, 2023
Stativ® Knotted UHMWPE Suture Anchor
K223889 · MBI
Healthium Medtech Limited
Orthopedic · 85d
Cleared Mar 22, 2023
SPIRA®-C Integrated Fixation System
K223837 · OVE
Camber Spine Technologies
Orthopedic · 90d
Cleared Mar 22, 2023
POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular...
K223824 · DRA
Boston Scientific Corporation
Cardiovascular · 91d
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
Ceribell Instant EEG Headcap
K223086 · GXY
Ceribell, Inc.
Neurology · 173d
Cleared Mar 22, 2023
CardioSTAT® ECG Test Solution
K223049 · DSH
Icentia, Inc.
Cardiovascular · 174d
Cleared Mar 22, 2023
MPXA-2000
K222036 · QIH
Medipixel, Inc.
Radiology · 254d
Cleared Mar 22, 2023
CEREC Tessera Abutment Block, CEREC Tessera Abutment System
K221402 · NHA
Dentsply Sirona, Inc.
Dental · 310d