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
13513–13536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2022
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
K213174 · PIF
Cardinalhealth
Gastroenterology & Urology · 233d
Cleared May 19, 2022
Artiglass NRFitTM Tip L.O.R. Glass Syringes
K213800 · QEH
Artiglass Srl
Anesthesiology · 164d
Cleared May 19, 2022
PINE Pedicle Screw System
K220285 · NKB
Tdm Co., Ltd.
Orthopedic · 107d
Cleared May 19, 2022
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
K220370 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 99d
Cleared May 19, 2022
PAPAYA 3D & PAPAYA 3D Plus
K220392 · OAS
Genoray Co., Ltd.
Radiology · 97d
Cleared May 19, 2022
PAPAYA & PAPAYA Plus
K220423 · MUH
Genoray Co., Ltd.
Radiology · 94d
Cleared May 19, 2022
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand...
K220485 · HBC
The Anspach Effort, Inc.
Neurology · 91d
Cleared May 19, 2022
SMR Reverse Liner
K220792 · MBF
Lima Corporate S.P.A.
Orthopedic · 62d
Cleared May 19, 2022
Medical Surgical Mask (Planar type)
K220824 · FXX
Hunan Chopard Medical Devices Co., Ltd.
General Hospital · 59d
Cleared May 19, 2022
Accu-Chek Safe-T-Pro Plus Lancing Device
K220849 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 57d
Cleared May 19, 2022
Procedure Mask with Ear Loops and Surgical Mask with Ties
K221134 · FXX
Safesource Direct, LLC
General Hospital · 30d
Cleared May 19, 2022
X-Twist PEEK Suture Anchor
K221135 · MBI
Parcus Medical, LLC
Orthopedic · 30d
Cleared May 19, 2022
Univers Revers Humeral Cup Implant
K221232 · HSD
Arthrex, Inc.
Orthopedic · 20d
Cleared May 18, 2022
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy...
K212408 · LZA
Pt. Maja Agung Latexindo
General Hospital · 288d
Cleared May 18, 2022
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood...
K212416 · DXQ
Wenzhou Xikang Medical Instruments...
Cardiovascular · 288d
Cleared May 18, 2022
MolecuLight I:X
K213840 · QJF
Moleculight, Inc.
General & Plastic Surgery · 160d
Cleared May 18, 2022
GSS610N21 Series Steam Sterilizer
K214120 · FLE
Maquet GmbH
General Hospital · 139d
Cleared May 18, 2022
Nitrile Powder Free Examination Gloves
K220211 · LZA
Hebei Kangxida Medical Technology...
General Hospital · 112d
Cleared May 18, 2022
Siren SGT
K220218 · KNT
Tools For Surgery, LLC
Gastroenterology & Urology · 112d
Cleared May 18, 2022
Medline Orbis LVL 3 Surgical Gown
K220333 · FYA
Medline Industries, LP
General Hospital · 103d
Cleared May 18, 2022
Osteotomy Truss System (OTS)
K220463 · HRS
4Web Medical, Inc.
Orthopedic · 90d
Cleared May 18, 2022
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices...
K220467 · GEX
Lumenis Be, Ltd.
General & Plastic Surgery · 90d
Cleared May 18, 2022
BENCOX Mirabo Cup System
K220468 · LPH
Corentec Co., Ltd.
Orthopedic · 90d
Cleared May 18, 2022
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel...
K220917 · FMK
Gri-Alleset, Inc.
General & Plastic Surgery · 49d