Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
35449–35472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2015
Biomet Microfixation OmniMax MMF System
K143336 · JEY
Biomet Microfixation
Dental · 132d
Cleared Apr 01, 2015
Argulated Locking Plates
K143338 · JEY
Osteomed LP
Dental · 132d
Cleared Apr 01, 2015
Silk Road Acccess Catheter
K143459 · DQY
Silk Road Medical, Inc.
Cardiovascular · 118d
Cleared Apr 01, 2015
Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
K150253 · GCJ
Taiwan Surgical Corporation
General & Plastic Surgery · 57d
Cleared Apr 01, 2015
K-Pack II Needle-21G x 2
K150263 · FMI
Terumo Europe N.V.
General Hospital · 56d
Cleared Apr 01, 2015
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology...
K150631 · DRF
St Jude Medical
Cardiovascular · 21d
Cleared Mar 31, 2015
NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES
K141181 · OHS
Led Technologies, LLC
General & Plastic Surgery · 328d
Cleared Mar 31, 2015
ALERE I STREP A
K141757 · PGX
Alere Scarborough, Inc.
Microbiology · 274d
Cleared Mar 31, 2015
MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
K141785 · NEY
Bsd Medical Corp.
General & Plastic Surgery · 272d
Cleared Mar 31, 2015
SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
K141991 · KNS
Olympus Medical Systems Copr.
Gastroenterology & Urology · 252d
Cleared Mar 31, 2015
Coalition AGX Plate and Coalition AGX Spacer
K142218 · ODP
Globus Medical, Inc.
Orthopedic · 231d
Cleared Mar 31, 2015
ADVIA Centaur Cortisol (COR) Assy
K142723 · JFT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 189d
Cleared Mar 31, 2015
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La)...
K142781 · LLL
Immco Diagnostics, Inc.
Immunology · 186d
Cleared Mar 31, 2015
Phasix Mesh
K142818 · OOD
C. R. Bard
General & Plastic Surgery · 183d
Cleared Mar 31, 2015
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert...
K143165 · HWC
Zimmer, Inc.
Orthopedic · 148d
Cleared Mar 31, 2015
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite...
K143567 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 105d
Cleared Mar 31, 2015
HeatLux Pro I
K150175 · ILY
Home Skinovations , Ltd.
Physical Medicine · 64d
Cleared Mar 31, 2015
Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301
K150234 · PCT
Myriad Medical, LLC
Radiology · 57d
Cleared Mar 31, 2015
Range/Denali/Mesa Spinal System
K150325 · NKB
K2m, Inc.
Orthopedic · 50d
Cleared Mar 31, 2015
Xcela Power Injectable PICC
K150527 · LJS
Navilyst Medical, Inc.
General Hospital · 29d
Cleared Mar 30, 2015
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
K141527 · HRS
Synthes (Usa)
Orthopedic · 294d
Cleared Mar 30, 2015
Ebony PTA 0.035 Peripheral Dilatation Catheter
K143036 · LIT
Natec Medical , Ltd.
Cardiovascular · 159d
Cleared Mar 30, 2015
IDS-iSYS CTX-I Calibration Verifiers
K143324 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 131d
Cleared Mar 30, 2015
Eminent Foot Plate System
K143365 · HRS
Eminent Spine
Orthopedic · 126d