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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
141313–141336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1986
CULTURIA MACCONKEY-MUG/CLED SYSTEMS
K864764 · JSI
Clinical Convenience Products, Inc.
Microbiology · 24d
Cleared Dec 29, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC
K864777 · FMF
Mac Lee Medical Products
General Hospital · 21d
Cleared Dec 29, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC
K864778 · FMF
Mac Lee Medical Products
General Hospital · 21d
Cleared Dec 29, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC
K864779 · FMF
Mac Lee Medical Products
General Hospital · 21d
Cleared Dec 29, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC
K864781 · FMF
Mac Lee Medical Products
General Hospital · 21d
Cleared Dec 29, 1986
EXACTECH TOTAL HIP INSTRUMENTS
K864788
Exactech, Inc.
Orthopedic · 21d
Cleared Dec 29, 1986
COLLINS POSITIONING DEVICE
K864880 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 17d
Cleared Dec 29, 1986
ARTHROSCOPIC ANKLE HOLDER
K864881 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 17d
Cleared Dec 24, 1986
FASCICULATED I ROD
K863215
The Deca Co.
Orthopedic · 126d
Cleared Dec 24, 1986
FASCICULATED BOAT ROD
K863239
The Deca Co.
Orthopedic · 124d
Cleared Dec 24, 1986
FASCICULATED S ROD
K863271
The Deca Co.
Orthopedic · 121d
Cleared Dec 24, 1986
MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN
K864184 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 58d
Cleared Dec 24, 1986
MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN
K864185 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 58d
Cleared Dec 24, 1986
HIGH FREQUENCY NEEDLE-TYPE EPILATOR
K864291 · KCW
Multi-Channel Epilator
General & Plastic Surgery · 54d
Cleared Dec 24, 1986
CARETEX SHOE COVERS
K864550 · FXP
James River Corp.
General Hospital · 35d
Cleared Dec 24, 1986
AKRO-SIL PLUS
K864736 · KOD
Akron Catheter, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 24, 1986
THE KEYMED HI-LIGHT 250 LIGHT SOURCE
K864801 · GCT
Keymed, Inc.
Gastroenterology & Urology · 15d
Cleared Dec 24, 1986
CLOWARD DISPOSABLE ARMRESTS AND FACE REST
K864804
Surgical Equipment International, Inc.
General & Plastic Surgery · 15d
Cleared Dec 24, 1986
CLOWARD SURGICAL SADDLE
K864805
Surgical Equipment International, Inc.
General & Plastic Surgery · 15d
Cleared Dec 24, 1986
INFECTIOUS TISSUE KIT
K864824
American Scientific Products
General & Plastic Surgery · 15d
Cleared Dec 24, 1986
RADIOGRAPHIC - LEG SECTION
K864846 · KQS
American Sterilizer Co.
Gastroenterology & Urology · 14d
Cleared Dec 24, 1986
2000LT WHEELCHAIR
K864901 · IOR
Invacare Corp.
Physical Medicine · 9d
Cleared Dec 24, 1986
HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR
K864918 · INO
Health Products, Inc.
Physical Medicine · 8d
Cleared Dec 23, 1986
BIOPSY ADAPTER #H4221BG
K864551 · GDF
General Electric Co.
General & Plastic Surgery · 34d