FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81073–81096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2000
DEPUY NEUFLEX PIP FINGER
K001922 · KYJ
Depuy, Inc.
Orthopedic · 67d
Cleared Aug 29, 2000
VECTOR TARGETING SYSTEM
K001938 · HSB
Vector Medical, Inc.
Orthopedic · 64d
Cleared Aug 29, 2000
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
K002138 · FPA
Maersk Medical A/S
General Hospital · 43d
Cleared Aug 29, 2000
PSI SKULL CLAMP
K002276 · HBL
V. Mueller Neuro/Spine
Neurology · 34d
Cleared Aug 29, 2000
MODULAR PORP AND TORP MODEL TBD
K002378 · ETA
Gyrus Ent LLC
Ear, Nose, Throat · 25d
Cleared Aug 29, 2000
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · MED
Advanced Sterilization Products
General Hospital · 22d
Cleared Aug 29, 2000
SMITH & NEPHEW OFF-CENTERED PORP
K002464 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 19d
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