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
38017–38040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 2014
EXHALATION VALVE
K132143 · CBP
Intersurgical Incorporated
Anesthesiology · 328d
Cleared Jun 04, 2014
ZIBONE CERAMIC DENTAL IMPLANT SYSTEM
K132585 · DZE
Coho Technology Co., Ltd.
Dental · 292d
Cleared Jun 04, 2014
PANPAC INFLATABLE DOCUT PESSARY
K132670 · HHW
Panpac Medical Corporation
Obstetrics & Gynecology · 281d
Cleared Jun 04, 2014
SOFTECH PLUS ETC02 CANNULA
K132946 · CCK
Teleflexmedical, Inc.
Anesthesiology · 258d
Cleared Jun 04, 2014
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
K133850 · EBF
Prismatik Dentalcraft, Inc.
Dental · 167d
Cleared Jun 04, 2014
ASTRAL VENTILATOR
K133868 · CBK
Resmed, Ltd.
Anesthesiology · 166d
Cleared Jun 04, 2014
STERISPINE PS
K140802 · NKB
Safe Orthopaedics
Orthopedic · 65d
Cleared Jun 04, 2014
VTI SUCTION IRRIGATION SYSTEM
K141323 · GCJ
Regulatory Technology Services, LLC
General & Plastic Surgery · 15d
Cleared Jun 03, 2014
AXON-BUS PROSTHETIC SYSTEM
K123795 · GXY
Otto Bock Austria
Neurology · 540d
Cleared Jun 03, 2014
MED-RX ORAL/ENTERAL SYRINGE
K131183 · KNT
Benlan, Inc.
Gastroenterology & Urology · 403d
Cleared Jun 03, 2014
EWNL SAFETY SYRINGE WITH NEEDLE
K132557 · FMI
Jiamei-Un Co., Ltd.
General Hospital · 293d
Cleared Jun 03, 2014
SMR TT METAL BACK GLENOID
K133349 · KWS
Lima Corporate S.P.A.
Orthopedic · 216d
Cleared Jun 03, 2014
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
K140026 · LZU
Lacrimedics, Inc.
Ophthalmic · 148d
Cleared Jun 03, 2014
OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5
K140226 · HRS
Science For Biomaterials
Orthopedic · 125d
Cleared Jun 03, 2014
0180 INTUITION, 0072 PRECISION
K140683 · KPR
Arcoma AB
Radiology · 77d
Cleared Jun 03, 2014
BIOMET CANNULATED SCREW SYSTEM
K140891 · HWC
Biomet, Inc.
Orthopedic · 56d
Cleared Jun 03, 2014
RANGE SPINAL SYSTEM
K141147 · NKB
K2m, Inc.
Orthopedic · 29d
Cleared Jun 02, 2014
LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM
K132016 · ILY
Texas Applied Biomedical Services, Inc.
Physical Medicine · 336d
Cleared Jun 02, 2014
POWDER FREE POLYETHYLENE EXAMINATION GLOVES
K133478 · LZA
Shijiazhuang Hongzan Plastic...
General Hospital · 202d
Cleared Jun 02, 2014
VIRAGE OCT SPINAL FIXATION SYSTEM
K133556 · KWP
Zimmer Spine, Inc.
Orthopedic · 195d
Cleared Jun 02, 2014
CHOCOLATE PTCA BOLLOON CATHETER
K133633 · LOX
Trireme Medical, Inc.
Cardiovascular · 188d
Cleared Jun 02, 2014
SCHOELLY ARTHROSCOPE
K133682 · HRX
Scholly Fiberoptic GmbH
Orthopedic · 182d
Cleared Jun 02, 2014
ARIA WIFI SMART SCALE
K133872 · MNW
Fitbit, Inc.
Gastroenterology & Urology · 164d
Cleared Jun 02, 2014
ASPIRON ACP SYSTEM
K140234 · KWQ
U&I Corp.
Orthopedic · 124d