FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13633–13656 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2022
ClearRead Xray Pneumothorax
K213566 · QFM
Riverain Technologies, Inc.
Radiology · 121d
Cleared Mar 10, 2022
NextAR™ TKA Platform My Knee PPS
K213751 · SBF
Medacta International S.A.
Orthopedic · 100d
Cleared Mar 10, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use with...
K213910 · LZC
Changzhou Universal Medical Equipment...
General Hospital · 85d
Cleared Mar 10, 2022
Hexa-Temp
K214071 · EBG
Spident Co., Ltd.
Dental · 73d
Cleared Mar 10, 2022
Sterilization Wraps
K220133 · FRG
Weihai Hongyu Nonwoven Fabric...
General Hospital · 51d
Cleared Mar 10, 2022
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K220361 · NZA
STERIS Corporation
General Hospital · 30d
Cleared Mar 09, 2022
Auto CPAP System
K211155 · BZD
BMC Medical Co., Ltd.
Anesthesiology · 324d
Cleared Mar 09, 2022
ZEN-2090 Turbo
K211780 · OWB
Genoray Co., Ltd.
Radiology · 273d
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