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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12073–12096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2022
OFNat Lubricant (L15)
K221243 · NUC
Suretex Limited
Obstetrics & Gynecology · 151d
Cleared Sep 30, 2022
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
K221378 · LZA
Tec Gloves Industry (M) Sdn.Bhd.
General Hospital · 141d
Cleared Sep 30, 2022
Unscented Menstrual Tampon
K222046 · HEB
Suzhou Borage Medical Technology Co.,...
Obstetrics & Gynecology · 81d
Cleared Sep 30, 2022
Safety Lancet
K222090 · FMK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 77d
Cleared Sep 30, 2022
Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
K222206 · IRP
Shenzhen Dongjilian Medical Tech Co.,...
Physical Medicine · 67d
Cleared Sep 30, 2022
Arthrex 3.5 mm Locking Compression Plates
K222244 · HRS
Arthrex, Inc.
Orthopedic · 66d
Cleared Sep 30, 2022
uDR 380i Pro
K222339 · IZL
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Sep 30, 2022
Shield System
K222625 · OWB
Radiaction , Ltd.
Radiology · 30d
Cleared Sep 30, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization...
K222849 · NVE
Steris
General Hospital · 9d
Cleared Sep 29, 2022
SpineAR SNAP
K213034 · SBF
Surgical Theater, Inc.
Orthopedic · 373d
Cleared Sep 29, 2022
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad,...
K213126 · JDO
Smith & Nephew, Inc.
Orthopedic · 367d
Cleared Sep 29, 2022
Ghost Spacer System
K213417 · MAX
Life Spine, Inc.
Orthopedic · 344d
Cleared Sep 29, 2022
InnovaBurn
K213716 · KGN
Triad Life Sciences, Inc.
General & Plastic Surgery · 309d
Cleared Sep 29, 2022
CogNet QmTRIAGE
K220080 · QFM
Medcognetics, Inc.
Radiology · 262d
Cleared Sep 29, 2022
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S,...
K221300 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 147d
Cleared Sep 29, 2022
CureSight-CS100
K221375 · QQU
Novasight , Ltd.
Ophthalmic · 140d
Cleared Sep 29, 2022
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S,...
K221496 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 129d
Cleared Sep 29, 2022
Surgical Gown (Sterile)
K221637 · FYA
Allmed Medical (Hubei) Protective...
General Hospital · 115d
Cleared Sep 29, 2022
ReFlow System Mini
K221918 · JXG
Anuncia Medical, Inc.
Neurology · 90d
Cleared Sep 29, 2022
S.I.N. Instrument Kits
K222005 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 84d
Cleared Sep 29, 2022
GM85
K222353 · IZL
Samsung Electronics Co., Ltd.
Radiology · 56d
Cleared Sep 29, 2022
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX...
K222383 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 55d
Cleared Sep 29, 2022
iFuse TORQ® Implant System
K222605 · OUR
SI-BONE, Inc.
Orthopedic · 31d
Cleared Sep 29, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
K222687 · MQB
Canon, Inc.
Radiology · 23d