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
16801–16824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 2021
Bencox THR System
K211866 · LPH
Corentec Co., Ltd.
Orthopedic · 28d
Cleared Jul 13, 2021
Electric Wheelchair [Models: JRWD6010/JRWD6012]
K192739 · ITI
Jerry Medical Instrument (Shanghai)...
Physical Medicine · 652d
Cleared Jul 13, 2021
ADVIA Centaur® Total hCG assay
K200210 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 532d
Cleared Jul 13, 2021
Finetest Lite Blood Glucose Monitoring System
K203562 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 218d
Cleared Jul 13, 2021
UltraTemp Rez II
K211237 · EMA
Ultradent Products, Inc.
Dental · 78d
Cleared Jul 13, 2021
Physica LMC Knee System
K211938 · JWH
Limacorporate
Orthopedic · 20d
Cleared Jul 12, 2021
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
K203556 · DSA
Medtronic, Inc.
Cardiovascular · 217d
Cleared Jul 12, 2021
Disposable Medical Face Mask
K210244 · FXX
Suzhou Bolisi Medical Technology Co.,...
General Hospital · 164d
Cleared Jul 12, 2021
Magneto Nasal Mask
K210386 · BZD
Respironics, Inc.
Anesthesiology · 153d
Cleared Jul 12, 2021
InMode RF Pro System
K210492 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 143d
Cleared Jul 12, 2021
Bone Screws dia. 5,0 mm
K210717 · PHX
Lima Corporate S.P.A.
Orthopedic · 124d
Cleared Jul 12, 2021
Nitrile Patient Examination Glove
K210723 · LZA
Jiangxi Zhonghong Pulin Medical...
General Hospital · 124d
Cleared Jul 12, 2021
Nitrile Examination Gloves
K210776 · LZA
5r Med Instruments (Chengdu) Co., Ltd.
General Hospital · 119d
Cleared Jul 12, 2021
Zavation Spinal System
K211113 · NKB
Zavation Medical Products, LLC
Orthopedic · 89d
Cleared Jul 12, 2021
RadiForce RX370
K211491 · PGY
Eizo Corporation
Radiology · 60d
Cleared Jul 12, 2021
EOS PMP
K211495 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 60d
Cleared Jul 12, 2021
PowerLook Density Assessment V4.0
K211506 · QIH
Icad, Inc.
Radiology · 59d
Cleared Jul 10, 2021
Medical Nitrile Examination Gloves (Power free, Blue)
K210578 · LZA
Jiangxi Hongda Medical Equipment...
General Hospital · 134d
Cleared Jul 09, 2021
TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
K200575 · HRS
Truemed Group, LLC
Orthopedic · 491d
Cleared Jul 09, 2021
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with...
K200915 · KGO
Gx Corporation Sdn Bhd
General Hospital · 459d
Cleared Jul 09, 2021
Microwave Therapeutic System
K201262 · NEY
Nanjing Eco Microwave System Co., Ltd.
General & Plastic Surgery · 424d
Cleared Jul 09, 2021
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
K201675 · LON
bioMerieux, Inc.
Microbiology · 385d
Cleared Jul 09, 2021
Cytrellis Dermal Micro-Coring System
K202517 · QAI
Cytrellis Biosystems, Inc.
General & Plastic Surgery · 311d
Cleared Jul 09, 2021
Tamarin Blue PTCA RX Dilatation Catheter
K210012 · LOX
Natec Medical , Ltd.
Cardiovascular · 186d