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
78433–78456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2001
PFC SIGMA LUGGED TIBIAL TRAY
K003026 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 264d
Cleared Jun 19, 2001
K'FIX
K010847 · NDL
Avanta Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jun 19, 2001
MERIDIAN-PORTABLE
K010897 · GZO
Meridian Co., Ltd.
Neurology · 85d
Cleared Jun 19, 2001
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
K010901 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 85d
Cleared Jun 19, 2001
MEDPOR QUAD MOTILITY IMPLANT
K010902 · HPZ
Porex Surgical, Inc.
Ophthalmic · 85d
Cleared Jun 19, 2001
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
K010927 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 83d
Cleared Jun 19, 2001
PROLITE VL PULSED LIGHT SYSTEM
K010928 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 83d
Cleared Jun 19, 2001
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 78d
Cleared Jun 19, 2001
FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM
K010988 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 78d
Cleared Jun 19, 2001
RESORBABLE HAMMERTOE PIN
K011137 · JDW
Biomet, Inc.
Orthopedic · 67d
Cleared Jun 19, 2001
ARTHREX BIO-TRANSFIX
K011172 · MNU
Arthrex, Inc.
Orthopedic · 63d
Cleared Jun 19, 2001
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
K011187 · FPA
Sterling Medivations, Inc.
General Hospital · 62d
Cleared Jun 19, 2001
TORNIER TOTAL ELBOW PROSTHESIS
K011567 · JDB
Tornier
Orthopedic · 29d
Cleared Jun 19, 2001
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND...
K011577 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 28d
Cleared Jun 19, 2001
ARTHROCARE CONTROLLER, MODEL H2000
K011634 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Jun 19, 2001
RADIAL HEAD IMPLANT
K011819 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 8d
Cleared Jun 19, 2001
INTERLINK THREADED LOCK CANNULA
K011858 · FPA
Bd
General Hospital · 5d
Cleared Jun 18, 2001
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
K010553 · NBW
Abbott Laboratories
Chemistry · 112d
Cleared Jun 18, 2001
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70...
K010870 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Jun 18, 2001
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE...
K010974 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 77d
Cleared Jun 18, 2001
FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW
K011211 · EBF
Dmg USA, Inc.
Dental · 60d
Cleared Jun 18, 2001
IBD-CHEK
K011396 · DEG
Techlab, Inc.
Immunology · 42d
Cleared Jun 18, 2001
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL...
K011548 · JJY
Medical Analysis Systems, Inc.
Chemistry · 31d
Cleared Jun 18, 2001
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
K011620 · LAN
Syva Co., Dade Behring, Inc.
Toxicology · 24d