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
12121–12144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2022
Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with...
K222058 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 102d
Cleared Oct 21, 2022
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU...
K210414 · FYC
Medtecs (Taiwan) Corp.
General Hospital · 617d
Cleared Oct 21, 2022
MCI-Neuro Fixation System
K212391 · GWO
Mci Medical Concept Innovation, Inc.
Neurology · 445d
Cleared Oct 21, 2022
IntraOp VSP Software Device
K213128 · LLZ
Xironetic, LLC
Radiology · 389d
Cleared Oct 21, 2022
Enteral Transition Adaptor
K220165 · PIO
GBUK Group, Ltd.
Gastroenterology & Urology · 274d
Cleared Oct 21, 2022
Onetouch Non-paraben Lubricant Gel
K220273 · NUC
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 263d
Cleared Oct 21, 2022
NextDent Ortho Flex
K221022 · MQC
Vertex-Dental B.V.
Dental · 198d
Cleared Oct 21, 2022
PureLift Pro Plus
K221443 · NFO
Xtreem Pulse, LLC
Neurology · 156d
Cleared Oct 21, 2022
DePuy Reclaim Monobloc Revision Femoral Stem
K221462 · LZO
Depuy Ireland UC
Orthopedic · 155d
Cleared Oct 21, 2022
Hair Removal Device (Model: IPL-D26, IPL-D19)
K221643 · OHT
Shenzhen Desida Technology Co., Ltd.
General & Plastic Surgery · 137d
Cleared Oct 21, 2022
NuVasive Cohere ALIF System Intervertebral Body Fusion Device
K221751 · OVD
Nu Vasive, Incorporated
Orthopedic · 127d
Cleared Oct 21, 2022
Flex-MI
K221958 · IPF
Emsi, Inc.
Physical Medicine · 108d
Cleared Oct 21, 2022
Electronic Pulse Stimulator
K221992 · NUH
Beijing Choice Electronic Technology...
Neurology · 107d
Cleared Oct 21, 2022
Safety Blood Collection Needle (Without Needle Holder)
K222141 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 93d
Cleared Oct 21, 2022
Collagen P.I.N. (Percutaneous Induction Needling)
K222199 · QAI
Induction Therapies, LLC
General & Plastic Surgery · 91d
Cleared Oct 21, 2022
Biological Feedback and Stimulation System
K222201 · IPF
Medlander Medical Technology, Inc.
Physical Medicine · 88d
Cleared Oct 21, 2022
IPD Dental Implant Abutments
K222215 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 88d
Cleared Oct 21, 2022
HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer,...
K222270 · ODP
Globus Medical, Inc.
Orthopedic · 84d
Cleared Oct 21, 2022
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
K222349 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 79d
Cleared Oct 21, 2022
UHR Bipolar Implants, Restoration GAP II Implants
K222632 · KWL
Howmedica Osteonics Corp., Dba...
Orthopedic · 51d
Cleared Oct 21, 2022
Viz LVO ContaCT
K223042 · QAS
Viz. Ai, Inc.
Radiology · 22d
Cleared Oct 20, 2022
BTI Interna Dental Implant System UnicCa - Prosthetic Components
K213106 · NHA
B.T.I. Biotechnology Institute, Sl.
Dental · 391d
Cleared Oct 20, 2022
AccuSert Needle Inserter
K213429 · KZH
Emed Technologies Corporation
General Hospital · 364d
Cleared Oct 20, 2022
Houdini Cross Support Catheter
K213466 · DQY
Cruzar Medsystems, Inc.
Cardiovascular · 357d