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
6961–6984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2024
Perforated Baskets
K231291 · KCT
Richard Wolf Medical Instruments...
General Hospital · 396d
Cleared May 31, 2024
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
K241248 · DWF
Spectrum Medical S.R.L.
Cardiovascular · 28d
Cleared May 31, 2024
Fixtemp® C&B 4:1
K241226 · EBG
Dreve Denatmid GmbH
Dental · 29d
Cleared May 31, 2024
Tyber Medical Anatomical Plating System
K241218 · HRS
Tyber Medical, LLC
Orthopedic · 30d
Cleared May 31, 2024
Electro Lube NXT
K241055 · GEI
Steris
General & Plastic Surgery · 44d
Cleared May 31, 2024
IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
K240969 · OHT
Shenzhen Semlamp Intelligent...
General & Plastic Surgery · 52d
Cleared May 31, 2024
Electric Wheelchair (HBLD3-B)
K240913 · ITI
Shanghai Hubang Intelligent...
Physical Medicine · 58d
Cleared May 31, 2024
Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
K240912 · EIH
Anhui Miisen Intelligence Technology...
Dental · 58d
Cleared May 31, 2024
CINA-VCF
K240612 · QFM
Avicenna.Ai
Radiology · 87d
Cleared May 31, 2024
multiFlux 1000 (F00012408)
K240394 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 113d
Cleared May 31, 2024
Bone Suppression Software
K240281 · LLZ
Konica Minolta, Inc.
Radiology · 120d
Cleared May 31, 2024
Blood Pressure Monitor (TMB-2296-BT)
K240254 · DXN
Guangdong Transtek Medical...
Cardiovascular · 121d
Cleared May 31, 2024
iHealth COVID-19 Antigen Rapid Test
K233842 · QYT
Ihealth Labs, Inc.
Microbiology · 179d
Cleared May 31, 2024
Ringer perfusion balloon catheter, 2.00 x 20mm (5881)
K233729 · LOX
Vascular Solutions, LLC
Cardiovascular · 192d
Cleared May 31, 2024
Stylus
K233591 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 205d
Cleared May 31, 2024
LFR-260
K233295 · SBI
Evolution Optiks Limited
Ophthalmic · 245d
Cleared May 31, 2024
Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
K232943 · QNQ
Smiths Medical Asd, Inc.
General Hospital · 254d
Cleared May 31, 2024
S.I.N. Dental Implant System
K232821 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 261d
Cleared May 31, 2024
BeamDose software (S080053)
K232738 · IYE
Ptw-Freiburg...
Radiology · 267d
Cleared May 31, 2024
Distinct® Digital Pregnancy Test
K232715 · LCX
ACON Laboratories, Inc.
Chemistry · 269d
Cleared May 31, 2024
BroncTru™ Transbronchial Access Tool
K232601 · EOQ
Broncus Medical, Inc.
Anesthesiology · 277d
Cleared May 31, 2024
Anti-bacterial bandage
K232333 · FRO
Jinhua Jingdi Medical Supplies Co., Ltd.
General & Plastic Surgery · 301d
Cleared May 31, 2024
°M Warmer System
K232107 · LGZ
Mequ A/S
General Hospital · 322d
Cleared May 31, 2024
Puracyn® Plus Antimicrobial Irrigation Solution
K232080 · FRO
Innovacyn, Inc.
General & Plastic Surgery · 323d