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
48937–48960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2010
AXLE INTERSPINOUS FUSION SYSTEM
K101471 · KWP
X-Spine Systems, Inc.
Orthopedic · 181d
Cleared Nov 24, 2010
CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
K101534 · GEI
Conmedcorp
General & Plastic Surgery · 174d
Cleared Nov 24, 2010
VITAL SIGNS MONITOR MODEL M3B
K101539 · DQA
Edan Instruments, Inc.
Anesthesiology · 174d
Cleared Nov 24, 2010
SIMPLEXA FLU A/B & RSV
K102170 · OCC
Focus Diagnostics, Inc.
Microbiology · 114d
Cleared Nov 24, 2010
A-DEC 200 DENTAL SYSTEM
K102234 · EIA
A-Dec, Inc.
Dental · 107d
Cleared Nov 24, 2010
AERODR SYSTEM
K102349 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 97d
Cleared Nov 24, 2010
HTO PLATING SYSTEM
K102505 · HRS
Aesculap Implant Systems, LLC
Orthopedic · 84d
Cleared CT Nov 24, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102690 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Nov 23, 2010
TRINITY ACETABULAR SYSTEM
K093472 · MEH
Corin USA
Orthopedic · 382d
Cleared Nov 23, 2010
LOCKING BONE SCREW MODEL HCQ04, HCZ04
K100721 · HWC
Changzhou Orthmar Medical Instrument...
Orthopedic · 253d
Cleared Nov 23, 2010
BIOGEL ORTHOPRO INDICATOR UNDERGLOVE
K101163 · KGO
Molnlycke Health Care USA
General Hospital · 211d
Cleared CT Nov 23, 2010
SCANVIEW HER2/NEU FISH SYSTEM
K101291 · NTH
Applied Spectral Imaging , Ltd.
Pathology · 200d
Cleared Nov 23, 2010
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL...
K101574 · OTF
ARK Diagnostics, Inc.
Toxicology · 169d
Cleared Nov 23, 2010
DEPUY RECLAIM REVISION HIP SYSTEM
K102080 · LZO
Depuy(Ireland)
Orthopedic · 120d
Cleared Nov 23, 2010
CLICKFINE PEN NEEDLE
K102108 · FMI
Ypsomed AG
General Hospital · 119d
Cleared Nov 23, 2010
GS 3000
K102202 · IPF
Emsi
Physical Medicine · 111d
Cleared Nov 23, 2010
FIBER FORCE
K102207 · EBI
Synca Marketing, Inc.
Dental · 110d
Cleared Nov 23, 2010
PVS MODEL 1.0
K102237 · IYE
Medcom GmbH
Radiology · 106d
Cleared Nov 23, 2010
DMP SINGLE BONDING
K102254 · KLE
Dmp, Ltd.
Dental · 105d
Cleared Nov 23, 2010
DMP ETCHING GEL
K102255 · EBF
Dmp, Ltd.
Dental · 105d
Cleared Nov 23, 2010
CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
K102339 · GAT
Conmed Linvatec
General & Plastic Surgery · 97d
Cleared Nov 23, 2010
EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM
K102343 · HWC
Emerge Medical
Orthopedic · 98d
Cleared Nov 23, 2010
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
K102429 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Nov 23, 2010
EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
K102791 · FTA
Image Stream Medical, Inc.
General & Plastic Surgery · 57d