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
36001–36024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2014
MORTARA MONITORING WAVEFORM VIEWER
K141811 · MHX
Mortara Instrument, Inc.
Cardiovascular · 135d
Cleared Nov 19, 2014
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO...
K141977 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 121d
Cleared Nov 19, 2014
EXPEDIUM VERSE SPINE SYSTEM
K142185 · NKB
Depuy Spine, Inc.
Orthopedic · 103d
Cleared Nov 19, 2014
AVS AS PEEK Spacer
K142251 · ODP
Stryker Corporation
Orthopedic · 97d
Cleared Nov 19, 2014
DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
K142399 · QBP
Catheter Connections, Inc.
General Hospital · 84d
Cleared Nov 19, 2014
Reline System
K142499 · NKB
Nu Vasive, Incorporated
Orthopedic · 75d
Cleared Nov 19, 2014
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea...
K142510 · HQD
Synergeyes, Inc.
Ophthalmic · 72d
Cleared Nov 19, 2014
VIAL-MATE Adaptor
K142600 · LHI
Baxter Healthcare Corporation
General Hospital · 65d
Cleared Nov 19, 2014
EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with...
K142999 · GEI
ArthroCare Corporation
General & Plastic Surgery · 33d
Cleared Nov 19, 2014
Xario 100, V3.0
K143046 · IYN
Toshibamedical Systems Corporation
Radiology · 28d
Cleared Nov 19, 2014
Arthrex iBalance Patella Implant, Dome
K143047 · JWH
Arthrex, Inc.
Orthopedic · 27d
Cleared Nov 18, 2014
J-SCREW COMPRESSION SCREW
K130019 · HWC
Competitive Engineering, Inc.
Orthopedic · 684d
Cleared Nov 18, 2014
UNEXEF-38G ULTRASOUND SYSTEM
K131973 · IYN
Toyota Tsusho Corporation
Radiology · 508d
Cleared Nov 18, 2014
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
K140085 · FEW
Cook Incorporated
Gastroenterology & Urology · 309d
Cleared Nov 18, 2014
TRACTION POLYPECTOMY SNARE
K140923 · FDI
Ovesco Endoscopy AG
Gastroenterology & Urology · 222d
Cleared Nov 18, 2014
AEQUALIS FX2
K141345 · PHX
Tornier S.A.S.
Orthopedic · 180d
Cleared Nov 18, 2014
INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K141390 · JOW
Wuhan Landing Medical Hi-Tech, Ltd.
Cardiovascular · 175d
Cleared Nov 18, 2014
RESCAN 700, CALLISTO EYE
K141844 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 133d
Cleared Nov 18, 2014
ERB ENDORECTAL BALLOON
K141958 · PCT
Edge Medical, LLC
Radiology · 123d
Cleared Nov 18, 2014
TRANSOM ANTERIOR CERVICAL PLATE
K142060 · KWQ
Neurostructures, Inc.
Orthopedic · 112d
Cleared Nov 18, 2014
LessRay with Tracking
K142243 · OWB
Saferay Spine, LLC
Radiology · 97d
Cleared Nov 18, 2014
Amedica Valeo II Interbody Fusion Device
K142347 · MAX
Amedica Corp.
Orthopedic · 88d
Cleared Nov 18, 2014
Vertical Expandable Prosthetic Titanium Rib
K142587 · MDI
Depuy Synthes Spine, Inc.
Orthopedic · 64d
Cleared Nov 18, 2014
Bio-Medicus Adult Cannulae and Introducer
K142673 · DWF
Medtronic, Inc.
Cardiovascular · 60d