FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77929–77952 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2001
AQUA WATER TREATMENT FOR HEMODIALYSIS
K010592 · FIP
Aqua Water Treatment, Inc.
Gastroenterology & Urology · 212d
Cleared Sep 28, 2001
UCLA AND UNIVERSAL ABUTMENTS
K010619 · DZE
Diamodent
Dental · 211d
Cleared Sep 28, 2001
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
K010749 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 199d
Cleared Sep 28, 2001
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K010882 · DZE
Blue Sky Bio
Dental · 189d
Cleared Sep 28, 2001
VYGON SPLIT CANNULA INTRODUCER
K010913 · DYB
Vygon Corp.
Cardiovascular · 185d
Cleared Sep 28, 2001
2010 PLUS HOLTER FOR WINDOWS
K010949 · MLO
Agilent Technologies
Cardiovascular · 183d
Cleared Sep 28, 2001
RANDOX LIPOPROTEIN
K011568 · JIS
Randox Laboratories, Ltd.
Chemistry · 130d
Cleared Sep 28, 2001
UNIPLANT DENTAL IMPLANT SYSTEM
K011574 · DZE
Universal Implant Systems, Inc.
Dental · 129d
Cleared Sep 28, 2001
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K012114 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Sep 28, 2001
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
K012173 · KWP
Sulzer Spine-Tech
Orthopedic · 78d
Cleared Sep 28, 2001
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K012270 · JDW
Stryker Endoscopy
Orthopedic · 71d
Cleared Sep 28, 2001
RAPIDIA
K012290 · LLZ
3D Med Co., Ltd.
Radiology · 70d
Cleared Sep 28, 2001
SYSMEX UF-50
K012372 · LKM
Sysmex Corp.
Pathology · 64d
Cleared Sep 28, 2001
MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
K012428 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 59d
Cleared Sep 28, 2001
MODIFICATION TO N PROTEIN STANDARD SL
K012470 · JIX
Dade Behring, Inc.
Chemistry · 57d
Cleared Sep 28, 2001
PLATELETWORKS
K012723 · JOZ
Helena Laboratories
Hematology · 44d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · MST
Diamedix Corp.
Immunology · 38d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · MST
Diamedix Corp.
Immunology · 38d
Cleared Sep 28, 2001
LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
K012907 · DIF
Clinical Controls
Chemistry · 30d
Cleared Sep 28, 2001
3I LOCATER ABUTMENT SYSTEM
K012911 · DZE
Implant Innovations, Inc.
Dental · 29d
Cleared Sep 28, 2001
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K012913 · DQY
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Sep 28, 2001
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K012926 · MTD
Endocardial Solutions, Inc.
Cardiovascular · 28d
Cleared Sep 28, 2001
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
K012934 · GKZ
Abbott Laboratories
Hematology · 28d
Cleared Sep 28, 2001
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K012939 · CAF
Monaghan Medical Corp.
Anesthesiology · 28d