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
27601–27624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2017
Mako Partial Knee Application
K172301 · OLO
Mako Surgical Corp.
Orthopedic · 94d
Cleared Nov 02, 2017
SOVEREIGN™ Spinal System
K172328 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 92d
Cleared Nov 02, 2017
Compound W Nitro-Freeze
K172373 · GEH
Medtech Products, Inc.
General & Plastic Surgery · 87d
Cleared Nov 02, 2017
Duracetal
K172407 · EBI
The Myerson Company Limited
Dental · 85d
Cleared Nov 02, 2017
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC...
K172437 · ODP
Orthofix, Inc.
Orthopedic · 83d
Cleared Nov 02, 2017
Sapphire Cervical Implant System
K172674 · ODP
Sapphire Medical Group
Orthopedic · 58d
Cleared Nov 02, 2017
Valleylab FX8 Electrosurgical Platform
K172757 · GEI
Covidien, LLC
General & Plastic Surgery · 50d
Cleared Nov 02, 2017
myMerlin(TM) Mobile Application Model APP1001
K173232 · MXC
St Jude Medical
Cardiovascular · 29d
Cleared Nov 02, 2017
Vivid E80, Vivid E90, Vivid E95
K173341 · IYN
GE Medical Systems
Radiology · 9d
Cleared Nov 01, 2017
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short...
K162812 · FPA
Unomedical A/S
General Hospital · 391d
Cleared Nov 01, 2017
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
K170353 · GKZ
HORIBA ABX SAS
Hematology · 271d
Cleared Nov 01, 2017
Sterisheet Sterilization Wrap
K170437 · FRG
Andersen Sterilizers, Inc.
General Hospital · 261d
Cleared Nov 01, 2017
AN87 Dosimeter
K170439 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 261d
Cleared Nov 01, 2017
MAUSER PG II Sharps Container
K170513 · MMK
Mauzer USA, LLC
General Hospital · 253d
Cleared Nov 01, 2017
Surgical Stainless Steel Suture, Stainless Steel Suture
K170767 · GAQ
Ethicon, Inc.
General & Plastic Surgery · 232d
Cleared Nov 01, 2017
Mytens Model: BW-TSX
K171026 · NUH
Bewell Connect Corp.
Neurology · 210d
Cleared Nov 01, 2017
IMAGEnet 6 Ophthalmic Data System
K171370 · NFJ
Topcon Corporation
Ophthalmic · 175d
Cleared Nov 01, 2017
Monitor B125, Monitor B105
K171580 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 154d
Cleared Nov 01, 2017
CoolSculpting System
K172144 · OOK
Zeltiq Aesthetics
General & Plastic Surgery · 107d
Cleared Nov 01, 2017
GMK Hinge, GMK Revision
K172347 · KRO
Medacta International S.A.
Orthopedic · 90d
Cleared Nov 01, 2017
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT,...
K172649 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 57d
Cleared Nov 01, 2017
Paramount Anterior Cervical Cage System
K173175 · OVE
Spine Wave, Inc.
Orthopedic · 33d
Cleared Oct 31, 2017
Trinity™ Dual Mobility System
K170359 · LZO
Corin U.S.A. Limited
Orthopedic · 267d
Cleared Oct 31, 2017
Anprolene SteriTest
K170427 · FRC
Andersen Sterilizers, Inc.
General Hospital · 260d