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

Filters: Cleared only ×
175,820 results
14737–14760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2022
BD Insulin Syringe (0.3mL)
K212499 · FMF
Becton, Dickinson and Company
General Hospital · 212d
Cleared Mar 09, 2022
PathLoc Lumbar Interbody Fusion Cage System
K213441 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 135d
Cleared Mar 09, 2022
SafeOp 2: Neural Informatix System
K213849 · GWF
Alphatec Spine, Inc.
Neurology · 89d
Cleared Mar 09, 2022
Disposable Medical Nitrile gloves
K213851 · LZA
Guangdong Xingcan Brothers Medical...
General Hospital · 89d
Cleared Mar 09, 2022
4K UHD LCD Monitor OEV321UH
K220069 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 58d
Cleared Mar 09, 2022
Genesys Spine 3DP Lumbar Interbody System
K220096 · MAX
Genesys Spine
Orthopedic · 56d
Cleared Mar 09, 2022
Amplatzer Steerable Delivery Sheath
K220340 · DQY
Abbott Medical
Cardiovascular · 30d
Cleared Mar 09, 2022
Acetabular Dome Hole Plug
K220376 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 27d
Cleared Mar 08, 2022
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus...
K203637 · EZD
Coloplast
Gastroenterology & Urology · 449d
Cleared Mar 08, 2022
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor...
K211138 · NLF
Stryker Sustainability Solutions
Anesthesiology · 326d
Cleared Mar 08, 2022
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed...
K211140 · DQA
Stryker Sustainability Solutions
Anesthesiology · 326d
Cleared Mar 08, 2022
Oclet TDS 1000
K212049 · LFL
Tendonova Corporation
General & Plastic Surgery · 251d
Cleared Mar 08, 2022
Elation Pulmonary Balloon Dilation Catheter
K213434 · KTI
Merit Medical Systems, Inc.
Ear, Nose, Throat · 137d
Cleared Mar 08, 2022
IPL Hair Removal Device
K213558 · ONF
Ulike Co., Ltd.
General & Plastic Surgery · 120d
Cleared Mar 08, 2022
TENS & EMS DEVICE (Model: FM-B2403A)
K213741 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 99d
Cleared Mar 08, 2022
Medical Face Mask
K214087 · FXX
Hubei Medlink Healthcare Co., Ltd.
General Hospital · 71d
Cleared Mar 08, 2022
EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
K220374 · NKB
Medos International SARL
Orthopedic · 27d
Cleared Mar 07, 2022
BTL-785W
K211639 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 284d
Cleared Mar 07, 2022
syngo.CT Applications
K220450 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 18d
Cleared Mar 07, 2022
SkinPen Precision System
K220506 · QAI
Crown Aesthetics
General & Plastic Surgery · 13d
Cleared Mar 04, 2022
InRoad® Dental Synthetic Bone Graft
K202675 · LYC
Osteogene Tech Corp
Dental · 535d
Cleared Mar 04, 2022
Disposable Automatically Retractable Insulin Safety Syringe
K210216 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 401d
Cleared Mar 04, 2022
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use...
K210330 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 393d
Cleared Mar 04, 2022
Second Opinion
K210365 · MYN
Pearl, Inc.
Radiology · 389d