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
13297–13320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2022
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
K220411 · NUJ
Stryker Sustainability Solutions
General & Plastic Surgery · 88d
Cleared May 13, 2022
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220429 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 87d
Cleared May 13, 2022
MAGNETOM Skyra Fit
K220589 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared May 13, 2022
Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
K220749 · FXX
Unimax Medical Products Co., Ltd.
General Hospital · 60d
Cleared May 13, 2022
Argo Knotless SP Anchor
K220757 · MBI
Conmed Corporation
Orthopedic · 59d
Cleared May 13, 2022
Pre-Formed Penile Silicone Block
K220760 · MIB
International Medical Devices, Inc.
General & Plastic Surgery · 59d
Cleared May 13, 2022
Arthrex Self-Punching PushLock Suture Anchor
K221099 · MAI
Arthrex, Inc.
Orthopedic · 29d
Cleared May 13, 2022
Quantib Prostate
K221106 · LLZ
Quantib B.V.
Radiology · 28d
Cleared May 13, 2022
Flow-Nail
K221115 · HSB
Flow-Fx, LLC
Orthopedic · 28d
Cleared May 13, 2022
XACT ACE Robotic System
K221116 · JAK
Xact Robotics, Ltd.
Radiology · 28d
Cleared May 13, 2022
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
K221144 · MQB
Radisen Co., Ltd.
Radiology · 23d
Cleared May 13, 2022
Telepack +
K221174 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 18d
Cleared May 12, 2022
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
K210937 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 409d
Cleared May 12, 2022
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K212620 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 267d
Cleared May 12, 2022
Laser hair growth helmet
K213025 · OAP
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 233d
Cleared May 12, 2022
Universal Pilot Guidance Instrument System
K213491 · OLO
Ctl Medical Corporation
Orthopedic · 192d
Cleared May 12, 2022
Sterile Hypodermic Syringes for Single Use
K213811 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 156d
Cleared May 12, 2022
Saige-Dx
K220105 · QDQ
DeepHealth, Inc.
Radiology · 120d
Cleared May 12, 2022
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free...
K220118 · LZA
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 118d
Cleared May 12, 2022
ANSiStim-PP
K220397 · NHI
Dyansys, Inc.
Neurology · 90d
Cleared May 12, 2022
Capsulo
K220430 · HQF
Quantel Medical
Ophthalmic · 86d
Cleared May 12, 2022
Synguard Nitrile Exam Glove
K220442 · LZA
Tianjin Aoshang Outdoor Equipment...
General Hospital · 85d
Cleared May 12, 2022
Hand Trauma Screw System
K220723 · HWC
Skeletal Dynamics, Inc.
Orthopedic · 59d
Cleared May 12, 2022
Motive Knee Wrap
K220738 · IPF
Cymedica Orthopedics, Inc.
Physical Medicine · 59d