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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
66025–66048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 2005
CYNOSUREA ECLILITE AND ECLILITE U
K050080 · FTC
Cynosure, Inc.
General & Plastic Surgery · 112d
Cleared May 05, 2005
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR...
K050325 · GXZ
Technomed Europe
Neurology · 85d
Cleared May 05, 2005
COMPRESSION ANASTOMOSIS RING (CAR)
K050356 · FZP
Niti Medical Technologies , Ltd.
General & Plastic Surgery · 80d
Cleared May 05, 2005
IMORGON ULTRASOUND PACS SOLUTIONS
K050736 · LLZ
Sea Ridge Software, Inc.
Radiology · 45d
Cleared May 05, 2005
SKIPPER AND SKIPPER RACE GUIDEWIRE
K050756 · DQX
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 43d
Cleared May 05, 2005
90XL INSTRUMENTATION SYSTEM
K050812 · FIZ
Mesa Laboratories, Inc.
Gastroenterology & Urology · 35d
Cleared May 05, 2005
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
K050874 · GBM
Astra Tech, Inc.
Gastroenterology & Urology · 29d
Cleared May 05, 2005
ECC.O SYSTEM
K050890 · KFM
Dideco S.R.L.
Cardiovascular · 27d
Cleared May 05, 2005
MODUS TITANIUM OSTEOSYNTHESIS SYSTEM
K050934 · JEY
Medartis, Inc.
Dental · 21d
Cleared May 05, 2005
BRIX WHEELCHAIR
K050941 · IOR
Meyra, Inc.
Physical Medicine · 21d
Cleared May 05, 2005
O-ARM IMAGING SYSTEM
K050996 · OXO
Breakaway Imaging, LLC
Radiology · 15d
Cleared May 05, 2005
DOPPLER-BOX
K051085 · IYN
Compumedics Germany Gmgh
Radiology · 7d
Cleared May 04, 2005
ATA HCM MONOPLACE HYPERBARIC SYSTEM
K040145 · CBF
Ata Hyperbaric Chamber Manufacturing
Anesthesiology · 468d
Cleared May 04, 2005
VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
K040916 · LYZ
Vitalcare Group, Inc.
General Hospital · 391d
Cleared May 04, 2005
SPIRO'AIR
K042595 · BZG
Morgan Scientific, Inc.
Anesthesiology · 223d
Cleared May 04, 2005
PROCOTYL-E ACETABULAR SYSTEM
K043073 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 177d
Cleared May 04, 2005
ORION DIAGNOSTICA UNIQ PINP RIA
K043125 · CIN
Orion Diagnostica, OY
Chemistry · 173d
Cleared May 04, 2005
LAGUNA PEDICLE SCREW SYSTEM
K050060 · MNI
Allez Spine, LLC
Orthopedic · 113d
Cleared May 04, 2005
IT NASAL MASK
K050171 · BZD
Innomed Technologies
Anesthesiology · 98d
Cleared May 04, 2005
THE GUIDED SURGERY CONCEPT
K050393 · DZE
Nobel Biocare AB
Dental · 77d
Cleared May 04, 2005
BASIS SPINAL SYSTEM
K050484 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 68d
Cleared May 04, 2005
WINDSURFER
K050561 · DQK
Medcon , Ltd.
Cardiovascular · 62d
Cleared May 04, 2005
NEUROLAC NERVE GUIDE
K050573 · JXI
Polyganics B.V.,
Neurology · 58d
Cleared May 04, 2005
RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
K050589 · GKZ
Sysmex America, Inc.
Hematology · 57d