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
82201–82224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2000
INTRASTENT DOUBLESTRUT PARAMOUNT
K001648 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 28, 2000
IMPROVED TRY-IN GEL
K001899 · EBF
Sybron Dental Specialties, Inc.
Dental · 67d
Cleared Aug 28, 2000
RIGID GAS PERMEABLE CONTACT LENS
K001960 · HQD
Polymer Technology
Ophthalmic · 62d
Cleared Aug 28, 2000
FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN...
K991495 · FIP
Fluid Process Systems, Inc.
Gastroenterology & Urology · 488d
Cleared Aug 26, 2000
CERAMIX PORCELAIN SYSTEM
K000983 · EIH
C-Mix
Dental · 152d
Cleared Aug 26, 2000
FLUOROTEX II SURGICAL MESH
K002351 · FTL
Bridger Biomed, Inc.
General & Plastic Surgery · 24d
Cleared Aug 25, 2000
C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
K000354 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 203d
Cleared Aug 25, 2000
C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580
K000356 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 203d
Cleared Aug 25, 2000
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808 · IPF
Rich-Mar Corp.
Physical Medicine · 165d
Cleared Aug 25, 2000
NLITE SYSTEM, SLS MODEL NUMBER A00-1025
K000811 · GEX
Sls Biophile , Ltd.
General & Plastic Surgery · 165d
Cleared Aug 25, 2000
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
K001681 · KPS
Smv America
Radiology · 85d
Cleared Aug 25, 2000
ULTIMA SMARTBELT, MODEL 0560
K001743 · BZQ
Braebon Medical Corp.
Anesthesiology · 78d
Cleared Aug 25, 2000
PLAINSENSE WHEELCHAIR
K001909 · IOR
Plainsense Wheelchairs, Inc.
Physical Medicine · 64d
Cleared Aug 25, 2000
REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800
K001923 · ITI
Gendron, Inc.
Physical Medicine · 63d
Cleared Aug 25, 2000
TITAN POROCOAT HIP PROSTHESIS
K001991 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 57d
Cleared Aug 25, 2000
LACTOSORB MENISCAL SCREW
K002020 · MAI
Biomet Manufacturing, Inc.
Orthopedic · 53d
Cleared Aug 25, 2000
BIOLOK SCREW
K002070 · HWC
Biocomposites, Ltd.
Orthopedic · 49d
Cleared Aug 25, 2000
XIMX SYSTEM
K002100 · LLZ
Medical Manager Research Development
Radiology · 45d
Cleared Aug 25, 2000
FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN
K002129 · MGQ
Ferris Mfg. Corp.
General & Plastic Surgery · 42d
Cleared Aug 25, 2000
RANGER II M6, MODEL IN-888WNL
K002157 · ITI
Invacare Corp.
Physical Medicine · 39d
Cleared Aug 25, 2000
KARMAN WHEELCHAIR
K002167 · IOR
Karman Healthcare, Inc.
Physical Medicine · 38d
Cleared Aug 25, 2000
CAPELLA
K002200 · EWO
Madsen Electronics, Inc.
Ear, Nose, Throat · 36d
Cleared Aug 25, 2000
KARMAN WHEELCHAIR
K002202 · IOR
Karman Healthcare, Inc.
Physical Medicine · 36d
Cleared Aug 25, 2000
SPINA SYSTEM
K002260 · ITH
North American Medical Corporation (Nam)
Physical Medicine · 31d