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
44521–44544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 2012
DRY MOUTH MOUTHWASH
K111250 · LFD
Dr. Fresh, Inc.
Dental · 359d
Cleared Apr 27, 2012
ECHOTIP(R) ULTRA FIDUCIAL NEEDLE
K111895 · NEU
Wilson-Cook Medical Inc./Cook Endoscopy
General & Plastic Surgery · 297d
Cleared Apr 27, 2012
NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
K112314 · KDI
Nephros, Inc.
Gastroenterology & Urology · 260d
Cleared Apr 27, 2012
GENESIS REUSABLE RIGID CONTAINER SYSTEM
K112535 · KCT
Carefusion 2200, Inc.
General Hospital · 239d
Cleared Apr 27, 2012
ENDOGATOR ADVANTAGE IRRIGATION PUMP
K113119 · OCX
Byrne Medical, Inc.
Gastroenterology & Urology · 189d
Cleared Apr 27, 2012
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS
K113221 · FRC
North American Science Assoc., Inc.
General Hospital · 178d
Cleared Apr 27, 2012
ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
K113286 · KGI
Ge Medical Systems Lunar
Radiology · 172d
Cleared Apr 27, 2012
SURGICASE CONNECT
K113599 · LLZ
Materialise NV
Radiology · 144d
Cleared Apr 27, 2012
ACCUDXA2
K113616 · KGI
Lone Oak Medical Technologies, LLC
Radiology · 142d
Cleared Apr 27, 2012
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K113707 · KGO
Cardinal Health-Medical Products and...
General Hospital · 133d
Cleared Apr 27, 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K113837 · LYZ
Hebei Changsheng Plastic Products...
General Hospital · 121d
Cleared Apr 27, 2012
R3 XLPE LINERS
K113848 · MBL
Smith & Nephew, Inc.
Orthopedic · 120d
Cleared Apr 27, 2012
CSM INTERNAL-R IMPLANT SYSTEM
K120043 · DZE
Csm Implant
Dental · 113d
Cleared Apr 27, 2012
APTUS PROXIMAL HUMERUS SYSTEM
K120108 · HRS
Medartis AG
Orthopedic · 105d
Cleared Apr 27, 2012
PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
K120341 · JAQ
Varian Medical Systems, Inc.
Radiology · 84d
Cleared Apr 27, 2012
VOLUSON S6, VOLUSON S8
K120741 · IYN
Ge Healthcare
Radiology · 46d
Cleared Apr 27, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K120746 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 46d
Cleared Apr 27, 2012
EPIFLO(R)
K120764 · KPJ
Neogenix, LLC
General & Plastic Surgery · 45d
Cleared Apr 27, 2012
SECURACATH
K120935 · OKC
Interrad Medical, Inc.
General Hospital · 30d
Cleared Apr 27, 2012
PATHASSIST LIGHT FIBER
K120962 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 28d
Cleared Apr 27, 2012
TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR...
K121106 · DWL
Surgical Appliance Industries, Inc.
General Hospital · 15d
Cleared Apr 26, 2012
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K110835 · LPL
GEO MEDICAL CO., LTD.
Ophthalmic · 398d
Cleared Apr 26, 2012
IROOT 100 MINI
K112153 · LQY
S-Denti Co., Ltd.
Dental · 294d
Cleared Apr 26, 2012
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
K112342 · KNT
Convatec, Inc.
Gastroenterology & Urology · 255d