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
71569–71592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2003
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM...
K031053 · EGJ
Selectivemed Components, Inc.
Physical Medicine · 48d
Cleared May 20, 2003
DISPOSABLE POWDERED VINYL EXAM GLOVES
K031134 · LYZ
Elite International, Inc.
General Hospital · 41d
Cleared May 20, 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-120
K031272 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 28d
Cleared May 20, 2003
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398 · DTL
Guidant Corp.
Cardiovascular · 15d
Cleared May 20, 2003
ROSS EMBRACE ENTERAL PUMP
K031407 · LZH
Ross Product Div. Abbott Laboratories
General Hospital · 15d
Cleared May 19, 2003
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
K030631 · FTL
Prosurg, Inc.
General & Plastic Surgery · 80d
Cleared May 19, 2003
DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC,...
K030952 · DQA
Dolphin Medical, Inc.
Anesthesiology · 54d
Cleared May 19, 2003
HEMOSIL FACTOR X DEFICIENT PLASMA
K031122 · GJT
Instrumentation Laboratory CO
Hematology · 41d
Cleared May 19, 2003
MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
K031285 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 26d
Cleared May 16, 2003
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
K023857 · NOM
Bio-Rad
Microbiology · 177d
Cleared May 16, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K023908 · JDK
Interpore Cross Intl.
Orthopedic · 172d
Cleared May 16, 2003
PEAK MOTUS
K030714 · LXJ
Peak Performance Technologies, Inc.
Physical Medicine · 71d
Cleared May 16, 2003
CD HORIZON SPINAL SYSTEM
K030932 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 52d
Cleared May 16, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML
K030986 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared May 16, 2003
EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO &...
K031078 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 42d
Cleared May 16, 2003
EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING...
K031080 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 42d
Cleared May 16, 2003
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
K031210 · DTB
Metronic, Inc.
Cardiovascular · 29d
Cleared May 16, 2003
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
K031218 · JDB
Tornier
Orthopedic · 29d
Cleared May 15, 2003
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
K022506 · MNR
Widemed, Ltd.
Anesthesiology · 289d
Cleared May 15, 2003
TENO FIX
K023594 · GAQ
Ortheon Medical, LLC
General & Plastic Surgery · 202d
Cleared May 15, 2003
MODIFICATION TO HORIZON SPINAL SYSTEM
K030840 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared May 15, 2003
COLLAGEN TOPICAL WOUND DRESSING
K030921 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 52d
Cleared May 15, 2003
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
K030925 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 52d
Cleared May 15, 2003
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K030947 · JCT
Alveolus, Inc.
General & Plastic Surgery · 50d