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
123193–123216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1990
CURITY SPINAL ANESTHESIA TRAY
K903761 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 121d
Cleared Dec 19, 1990
CYGNET CENTRAL
K903992 · HGM
Cygnet Co., Inc.
Obstetrics & Gynecology · 112d
Cleared Dec 19, 1990
SAFETY NEEDLE SHEATH
K904198 · FMI
Concord/Portex
General Hospital · 98d
Cleared Dec 19, 1990
SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A
K904342 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 89d
Cleared Dec 19, 1990
LPI MULILASE YAG/532 SURGICAL LASER SYSTEM
K904354 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 86d
Cleared Dec 19, 1990
HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS
K904610 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 69d
Cleared Dec 19, 1990
GDC-1475
K904614 · EJT
Deringer-Ney, Inc.
Dental · 69d
Cleared Dec 19, 1990
T.C.S. TOTAL CONTACT SEAT
K905013 · KNN
Fundamental Products Co.
Physical Medicine · 43d
Cleared Dec 19, 1990
DERMABRADER
K905046 · GFE
Aaron Medical Industries
General & Plastic Surgery · 41d
Cleared Dec 19, 1990
COMFORT-AIRE
K905126 · IOQ
Advanced Air Dynamics, Inc.
Physical Medicine · 35d
Cleared Dec 19, 1990
BONE RASPS
K905187 · HSZ
Micro Surgical Instruments Corp.
Orthopedic · 30d
Cleared Dec 19, 1990
YANKAUER SUCTION DEVICE
K905478 · MDM
Medovations, Inc.
General & Plastic Surgery · 13d
Cleared Dec 19, 1990
ZOETIC GLOVES
K905515 · LYY
Janco Polymers Pvt., Ltd.
General Hospital · 9d
Cleared Dec 19, 1990
PATIENT EXAMINATION GLOVES
K905550 · LYY
Medical Device Inspection Co., Inc.
General Hospital · 8d
Cleared Dec 18, 1990
CONTROL-TIP CYSTOSCOPIC ELECTRODES
K903156 · FAS
North American Sterilization &...
Gastroenterology & Urology · 153d
Cleared Dec 18, 1990
FLEXIBLE ENDOSCOPIC ELECTRODES
K903162 · FAS
North American Sterilization &...
Gastroenterology & Urology · 153d
Cleared Dec 18, 1990
TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER
K903421 · HQF
Top Con
Ophthalmic · 140d
Cleared Dec 18, 1990
TOXO-CUBE
K903968 · LGD
Difco Laboratories, Inc.
Microbiology · 112d
Cleared Dec 18, 1990
NITRO BLUE TETRAZOLIUM REDUCTION
K904022 · GHD
Sigma Chemical Co.
Pathology · 110d
Cleared Dec 18, 1990
LOCAL REPORT GENERATOR
K904318 · DXN
Spacelabs, Inc.
Cardiovascular · 89d
Cleared Dec 18, 1990
DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG
K904407 · GEX
Fiber Delivery Concepts, Inc.
General & Plastic Surgery · 83d
Cleared Dec 18, 1990
XENON LIGHT SOURCE
K904609 · HBI
Medical Dynamics, Inc.
General & Plastic Surgery · 68d
Cleared Dec 18, 1990
FLOWERS NASAL IMPLANT
K904656 · FZE
Implantech Associates, Inc.
General & Plastic Surgery · 64d
Cleared Dec 18, 1990
FLOWERS DORSAL COLUMELLA IMPLANT
K904657 · FZE
Implantech Associates, Inc.
General & Plastic Surgery · 64d