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
77521–77544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K014194 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Jan 17, 2002
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · DQY
C.R. Bard, Inc.
Cardiovascular · 27d
Cleared Jan 17, 2002
SIEMENS INFINITY GATEWAY SUITE
K014213 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 27d
Cleared Jan 17, 2002
BREATHTEK - UBIT UBT FOR H. PYLORI
K014225 · MSQ
Meretek Diagnostics, Inc.
Microbiology · 22d
Cleared Jan 17, 2002
MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND:...
K014234 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 22d
Cleared Jan 16, 2002
LUMEND PERCUTANEOUS CATHETER
K011562 · DQY
Lumend, Inc.
Cardiovascular · 240d
Cleared Jan 16, 2002
OSTEOMED BIORESORBABLE FIXATION SYSTEM
K012486 · DZL
Osteomed Corp.
Dental · 167d
Cleared Jan 16, 2002
KONICA LASER IMAGER, DRYPRO MODEL 751/752
K013052 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 127d
Cleared Jan 16, 2002
SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9
K013560 · KGO
Semperit Technische Produkte Gesellshaft
General Hospital · 82d
Cleared Jan 16, 2002
NEXUS 2 CLEAR
K013609 · EMA
Sybron Dental Specialties, Inc.
Dental · 77d
Cleared Jan 16, 2002
REVOLUTION FORMULA 2
K013647 · EBF
Sybron Dental Specialties, Inc.
Dental · 72d
Cleared Jan 16, 2002
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · IZH
Planmed OY
Radiology · 71d
Cleared Jan 16, 2002
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC...
K013833 · DQX
Guidant Corp.
Cardiovascular · 58d
Cleared Jan 16, 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 58d
Cleared Jan 16, 2002
HL168E
K014122 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Jan 16, 2002
NUMED COEFFICIENT PTV CATHETERS
K014124 · OMZ
NuMED, Inc.
Cardiovascular · 30d
Cleared Jan 16, 2002
MODIFICATION TO EBI OMEGA 21 SYSTEM
K014137 · MNH
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 16, 2002
LOGIQBOOK
K014206 · IYO
General Electric Co.
Radiology · 26d
Cleared Jan 15, 2002
RANDOX CARBAMAZEPINE
K011648 · KLT
Randox Laboratories, Ltd.
Toxicology · 231d
Cleared Jan 15, 2002
RANDOX VALPROIC ACID
K011649 · LEG
Randox Laboratories, Ltd.
Toxicology · 231d
Cleared Jan 15, 2002
PASS SPINAL SYSTEM
K013442 · KWP
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 15, 2002
ISOBAR SPINAL SYSTEM
K013447 · KWP
Scien'Tx USA, Inc.
Orthopedic · 90d
Cleared Jan 15, 2002
PRISMASATE
K013448 · KPO
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Jan 15, 2002
ACCENT
K013574 · LLZ
Confirma, Inc.
Radiology · 78d