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
41161–41184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 2013
IOGYN ENDOSCOPE
K123330 · HIH
Iogyn, Inc.
Obstetrics & Gynecology · 144d
Cleared Mar 19, 2013
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K123351 · DTM
Medtronic Perfusion Systems
Cardiovascular · 139d
Cleared Mar 19, 2013
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED
K123415 · DZE
Biodenta Swiss AG
Dental · 134d
Cleared Mar 19, 2013
VIA MICROCATHETER, VIA PLUS MICROCATHETER
K123477 · KRA
Sequent Medical, Inc.
Cardiovascular · 126d
Cleared Mar 19, 2013
CADWELL DISPOSABLE PROBE HANDLE
K123589 · PDQ
Cadwell
Neurology · 118d
Cleared Mar 19, 2013
GUIDEZILLA GUIDE EXTENSION CATHETER
K123765 · DQY
Boston Scientific
Cardiovascular · 102d
Cleared Mar 19, 2013
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
K130157 · JJX
Aalto Scientific, Ltd.
Chemistry · 55d
Cleared Mar 19, 2013
ORBIT INFUSION SET
K130468 · FPA
Ypsomed AG
General Hospital · 22d
Cleared Mar 18, 2013
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR...
K122059 · MBI
Smith & Nephew, Inc.
Orthopedic · 248d
Cleared Mar 18, 2013
BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
K122702 · ONT
Filligent Limited
General Hospital · 195d
Cleared Mar 18, 2013
URGOCLEAN ABSORBENT WOUND DRESSING
K123219 · FRO
Laboratoires Urgo
General & Plastic Surgery · 154d
Cleared Mar 18, 2013
JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS...
K123485 · MBI
Biomet Sports Medicine
Orthopedic · 125d
Cleared Mar 18, 2013
3M ATTEST(TM) AUTO-READER
K123546 · FRC
3M Company
General Hospital · 119d
Cleared Mar 18, 2013
STERILE LATEX SURGICAL GLOVE
K123628 · KGO
Lucenxia Prescience AG
General Hospital · 115d
Cleared Mar 18, 2013
LANX FUSION SYSTEM- SA
K123767 · OVD
Lanx, Inc.
Orthopedic · 101d
Cleared Mar 18, 2013
ACUMED CANNULATED SCREW SYSTEM
K123890 · HWC
Acumed, LLC
Orthopedic · 90d
Cleared Mar 15, 2013
ULTRASONIC NEBULIZER (MESH TYPE)
K121520 · CAF
K-Jump Health Co., Ltd.
Anesthesiology · 297d
Cleared Mar 15, 2013
3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER...
K121593 · FRC
3M Company
General Hospital · 288d
Cleared Mar 15, 2013
X-FIX DYNAMIC EXTERNAL DISTRACTOR
K122415 · HTY
Arex USA, LLC
Orthopedic · 219d
Cleared Mar 15, 2013
RAYSCAN A-EXPERT
K122918 · MUH
Ray Co., Ltd.
Radiology · 172d
Cleared Mar 15, 2013
GALILEOS FAMILY
K123070 · OAS
Sirona Dental Systems GmbH
Radiology · 165d
Cleared Mar 15, 2013
TVC IMAGING SYSTEM MODEL NIRS-MC7-70
K123108 · OGZ
Infraredx, Inc.
Cardiovascular · 163d
Cleared Mar 15, 2013
BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
K123225 · LOD
Aap Biomaterials GmbH & Co. KG
Orthopedic · 151d
Cleared Mar 15, 2013
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
K123298 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 143d