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
78529–78552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2001
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT...
K012876 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 35d
Cleared Oct 01, 2001
SONICWAVE SONIC PLAQUE REMOVER
K012914 · JEQ
Homedics, Inc.
Dental · 32d
Cleared Oct 01, 2001
BELLEGLASS HP ENAMEL 2
K013007 · EBF
Sybron Dental Specialties, Inc.
Dental · 25d
Cleared Oct 01, 2001
EXHALE PROBE
K013111 · EOQ
Broncus Technologies, Inc.
Radiology · 13d
Cleared Sep 28, 2001
OMNICARE DENTAL IMPLANT SYSTEM
K000035 · DZE
Omnicare Dental Implant Center
Dental · 631d
Cleared Sep 28, 2001
MIS IMPLANT SYSTEM DECIVE
K003191 · DZE
Mis Implants Technologies , Ltd.
Dental · 353d
Cleared Sep 28, 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 295d
Cleared Sep 28, 2001
UNIVERSAL DENTAL COPING (UDC)
K010467 · DZE
Paxmed International
Dental · 224d
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