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
72697–72720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 15, 2003
SURGISIS NERVE CUFF
K031069 · JXI
Cook Biotech, Inc.
Neurology · 41d
Cleared May 15, 2003
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
K031295 · PAG
C.R. Bard, Inc.
Gastroenterology & Urology · 22d
Cleared May 15, 2003
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
K031332 · FTM
C.R. Bard, Inc.
General & Plastic Surgery · 17d
Cleared May 15, 2003
TPSA FLEX REAGENT CARTRIDGE
K031343 · LTJ
Dade Behring, Inc.
Immunology · 16d
Cleared May 14, 2003
COZART EIA COTININE URINE KIT
K021944 · MKU
Cozart Bioscience , Ltd.
Toxicology · 335d
Cleared May 14, 2003
COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR
K023733 · GEI
Ingenjorsfirman Bjorn Bergdahl AB
General & Plastic Surgery · 189d
Cleared May 14, 2003
L600 HAIR REMOVAL
K030480 · GEX
A&M Technology
General & Plastic Surgery · 90d