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
83137–83160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2000
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
K994338 · DHR
Cogent Diagnotics , Ltd.
Immunology · 42d
Cleared Feb 03, 2000
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS
K994415 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 36d
Cleared Feb 03, 2000
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K994416 · LYY
Flexitech Sdn. Bhd.
General Hospital · 36d
Cleared Feb 02, 2000
QUINN'S SPERM WASHING MEDIUM
K991379 · MQL
Advanced Reproductive Technologies
Obstetrics & Gynecology · 287d
Cleared Feb 02, 2000
HYALURONIDASE, 80 U/ML
K991393 · MQL
Sage Biopharma
Obstetrics & Gynecology · 287d
Cleared Feb 02, 2000
SNAP MODEL 5
K992322 · MNR
Snap Laboratories, LLC
Anesthesiology · 205d
Cleared Feb 02, 2000
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR
K992787 · HQD
Specialty Ultravision, Inc.
Ophthalmic · 167d
Cleared Feb 02, 2000
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K993580 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 103d
Cleared Feb 02, 2000
SUPER TISSUE
K993742 · IYE
I.Z.I. Corp.
Radiology · 90d
Cleared Feb 02, 2000
PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV...
K993750 · LLZ
Problem Solving Concepts, Inc.
Radiology · 89d
Cleared Feb 02, 2000
COROMETRICS MODEL 173 FETAL MONITOR
K993751 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 89d
Cleared Feb 02, 2000
SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED
K993779 · HIS
P.T. Vonix Latexindo Condom (Rubber)...
Obstetrics & Gynecology · 86d
Cleared Feb 02, 2000
SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
K993781 · HIS
P.T. Vonix Latexindo Condom (Rubber)...
Obstetrics & Gynecology · 86d
Cleared Feb 02, 2000
SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9)
K993782 · HIS
P.T. Vonix Latexindo Condom (Rubber)...
Obstetrics & Gynecology · 86d
Cleared Feb 02, 2000
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY
K993786 · BTR
Rusch Intl.
Anesthesiology · 86d
Cleared Feb 02, 2000
TOKUYAMA ONE-UP-BOND F
K993917 · KLE
Tokuyama America, Inc.
Dental · 77d
Cleared Feb 02, 2000
ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT
K994261 · EMA
Ultradent Products, Inc.
Dental · 47d
Cleared Feb 01, 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS...
K000044 · GEI
Arthrocare Corp.
General & Plastic Surgery · 25d
Cleared Feb 01, 2000
IONTOPATCH
K992708 · EGJ
Birch Point Medical, Inc.
Physical Medicine · 174d
Cleared Feb 01, 2000
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
K993085 · MID
Cogent Diagnotics , Ltd.
Immunology · 139d
Cleared Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
K993547 · CFN
Beckman Coulter, Inc.
Immunology · 105d
Cleared Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
K993549 · CFN
Beckman Coulter, Inc.
Immunology · 105d
Cleared Feb 01, 2000
GTI-FVIII INHIBITOR ASSAY
K993553 · GGP
Genetic Testing Institute
Hematology · 104d
Cleared Feb 01, 2000
HSV-2 ELISA IGG, MODEL EL0920G
K993724 · MYF
Mrl Diagnostics
Microbiology · 90d