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
79561–79584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 15, 2001
NEURO-TRAIN III (3)
K003433 · IPF
Sterne Equipment Co., Ltd.
Physical Medicine · 221d
Cleared Jun 15, 2001
ACTI-ICP MONITORING SYSTEM
K003905 · GWM
Innerspace, Inc.
Neurology · 178d
Cleared Jun 15, 2001
CORDIS M3 PTA DILATATION CATHETER
K003920 · DQY
Cordis Corp.
Cardiovascular · 178d
Cleared Jun 15, 2001
NTERO NOMAD SYSTEM
K010815 · GEI
Ntero Surgical, Inc.
General & Plastic Surgery · 88d
Cleared Jun 15, 2001
MX8000 V5.0 CT SYSTEM
K010817 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Jun 15, 2001
HANDMASTER
K010837 · GZI
Neuromusclar Electrical Stimulation...
Neurology · 87d
Cleared Jun 15, 2001
MALE NATURAL RUBBER LATEX CONDOM
K010919 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 80d