FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
23833–23856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2019
Neo Cage System TM
K181048 · MAX
Neo Medical SA
Orthopedic · 285d
Cleared Jan 29, 2019
Cortex CAD/CAM Abutments
K181580 · NHA
Cortex Dental Implants Industries , Ltd.
Dental · 228d
Cleared Jan 29, 2019
T-PLUS
K181893 · PBX
Wintecare SA
General & Plastic Surgery · 200d
Cleared Jan 29, 2019
AQrate Robotic Assistance System
K182000 · HAW
Globus Medical, Inc.
Orthopedic · 187d
Cleared Jan 29, 2019
FastPack IP Sex Hormone Binding Globulin Immunoassay
K182521 · CDZ
Qualigen, Inc.
Chemistry · 138d
Cleared Jan 29, 2019
X5 Series Digital Color Doppler Ultrasound System
K182648 · IYN
Sonoscape Medical Corp.
Radiology · 127d
Cleared Jan 29, 2019
Solitaire 4 Revascularization Device
K183022 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 89d
Cleared Jan 29, 2019
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
K183070 · MOF
Asahi Intecc Co., Ltd.
Neurology · 85d
Cleared Jan 28, 2019
Greenmedi Safety Filter Syringe
K173743 · MEG
Sang-A Frontec Co., Ltd.
General Hospital · 417d
Cleared Jan 28, 2019
VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
K180822 · MAX
Wenzel Spine, Inc.
Orthopedic · 304d
Cleared Jan 28, 2019
Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
K181307 · JDC
Zimmer, Inc.
Orthopedic · 256d
Cleared Jan 28, 2019
Quantum Blood and IV Fluid Infusion Warmer
K181775 · LGZ
Life Warmer, Inc.
General Hospital · 209d
Cleared Jan 28, 2019
ZOLL ECG Analysis Software
K182093 · DPS
Zoll Manufacturing Corporation
Cardiovascular · 178d
Cleared Jan 28, 2019
MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
K182228 · NHA
Mis Implants Technologies , Ltd.
Dental · 165d
Cleared Jan 28, 2019
Cervical Spacer
K182477 · ODP
Additive Implants, LLC
Orthopedic · 140d
Cleared Jan 28, 2019
WEGO-PGLA RAPID
K183001 · GAM
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 90d
Cleared Jan 28, 2019
WEGO-PGA RAPID
K183004 · GAM
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 90d
Cleared Jan 28, 2019
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts,...
K183025 · JWH
B-One Ortho, Corp.
Orthopedic · 88d
Cleared Jan 28, 2019
Venue GO
K183362 · IYN
GE Medical Systems Ultrasound and...
Radiology · 55d
Cleared Jan 28, 2019
Aloka Arietta 850
K183456 · IYN
Hitachi Healthcare Americas
Radiology · 46d
Cleared Jan 25, 2019
NEST Interbody System
K180230 · MAX
Paonan Biotech Co., Ltd.
Orthopedic · 364d
Cleared Jan 25, 2019
microINR System
K180780 · GJS
Iline Microsystems, S.L.
Hematology · 305d
Cleared Jan 25, 2019
MiniCollect K2E K2EDTA Tubes
K182078 · JKA
Greiner Bio-One Na, Inc.
Hematology · 176d
Cleared Jan 25, 2019
Sysmex XN-L Automated Hematology Analyzer
K182389 · GKZ
Sysmex America, Inc.
Hematology · 143d