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
10801–10824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2023
EVA5 Insufflator
K230474 · FCX
Palliare , Ltd.
Gastroenterology & Urology · 30d
Cleared Mar 24, 2023
SmartMTA Capsule
K230797 · KIF
Sprig Oral Health Technologies, Inc.
Dental · 2d
Cleared Mar 23, 2023
VHT-200 Wound Treatment System
K212121 · KPJ
Vaporox, Inc.
General & Plastic Surgery · 624d
Cleared Mar 23, 2023
Sterile Hypodermic Syringe for Single Use
K212207 · FMF
Shandong Weigao Group Medical Polymer...
General Hospital · 616d
Cleared Mar 23, 2023
Implant-One Multi-Unit Abutment
K212394 · NHA
Implant Logistics, Inc.
Dental · 598d
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
AccurSound Electronic Stethoscope AS-101
K221805 · DQD
Heroic Faith International , Ltd.
Cardiovascular · 274d
Cleared Mar 23, 2023
Endo Ultrasonic Activator
K222096 · ELC
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 248d
Cleared Mar 23, 2023
RESPONSE 5.5/6.0 Cannulated Screw System
K222105 · NKB
OrthoPediatrics Corp.
Orthopedic · 248d
Cleared Mar 23, 2023
Sterilization Wrap
K222151 · FRG
Kenpax International Limited
General Hospital · 246d
Cleared Mar 23, 2023
MeMed BV
K222332 · QPS
MeMed Diagnostics, Ltd.
Microbiology · 233d
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