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

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176,076 results
57169–57192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 2008
KFH ENERGY, MODEL: E1
K073008 · GZJ
Kingfisher Healthcare NV
Neurology · 139d
Cleared Mar 11, 2008
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
K073041 · KAM
Acclarent, Inc.
General & Plastic Surgery · 134d
Cleared Mar 11, 2008
GRAFTYS BCP
K073064 · MQV
Graftys
Orthopedic · 133d
Cleared Mar 11, 2008
TRANS1 FACET SCREW
K073515 · MRW
Trans1 Incorporated
Orthopedic · 88d
Cleared Mar 11, 2008
ATRICURE COOLRAIL LINEAR PEN
K073605 · OCL
AtriCure, Inc.
Cardiovascular · 81d
Cleared Mar 11, 2008
MODIFICATION TO VIEWMATE SYSTEM
K073709 · IYN
Ep Medsystems
Radiology · 71d
Cleared Mar 11, 2008
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC,...
K080087 · KNG
Edan Instruments, Inc.
Radiology · 60d
Cleared Mar 11, 2008
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
K080272 · ITX
Boston Scientific Corp
Radiology · 39d
Cleared Mar 11, 2008
INTEGRE, MODEL LP581
K080423 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 25d
Cleared Mar 10, 2008
MERRIES K-PHATE BONE GRAFT SUBSTITUTE
K063157 · MQV
Merries International, Inc.
Orthopedic · 510d
Cleared Mar 10, 2008
DUREX PLAY MASSAGE GEL LUBRICANT
K063385 · NUC
Ssl Americas, Inc.
Obstetrics & Gynecology · 488d
Cleared Mar 10, 2008
JNE IMPLANT SYSTEM
K072425 · DZE
GC America, Inc.
Dental · 194d
Cleared Mar 10, 2008
OMNI-VUE SYSTEM
K073062 · LLZ
Genesis Digital Imaging, Inc.
Radiology · 132d
Cleared Mar 10, 2008
SYSTEM PLUS
K073475 · ELW
Continental Dental Laboratory
Dental · 90d
Cleared Mar 10, 2008
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE,...
K073484 · ODC
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 10, 2008
MRJ EXTENDED
K080098 · LNH
Paramed S.R.L.
Radiology · 56d
Cleared Mar 10, 2008
HFO SHOULDER COIL
K080120 · MOS
Philips Medical Systems MR Finland
Radiology · 53d
Cleared Mar 10, 2008
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION...
K080258 · NKB
Endius, Inc.
Orthopedic · 39d
Cleared Mar 10, 2008
KIMBA MINI
K080349 · MQP
Signus Medizintechnik GmbH
Orthopedic · 28d
Cleared Mar 10, 2008
IPULSE, MODEL I400
K080406 · GEX
Cyden Limited
General & Plastic Surgery · 25d
Cleared Mar 10, 2008
5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520
K080422 · LLZ
Eizo Nanao Corporation
Radiology · 24d
Cleared Mar 07, 2008
ZIMMER POROLOCK MIS STEM
K071723 · KWA
Zimmer GmbH
Orthopedic · 256d
Cleared Mar 07, 2008
AMADEUS ADAPTIVE COMPRESSION THERAPY
K071763 · JOW
Convatec
Cardiovascular · 252d
Cleared Mar 07, 2008
TENS/IF 14
K071869 · GZJ
Emsi
Neurology · 245d