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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
104041–104064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1995
POWERFLEX(TM) 5F PTA BALLOON CATHETER
K946052 · LIT
Cordis Corp.
Cardiovascular · 81d
Cleared Mar 03, 1995
LAPAROSCOPE
K950076 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 53d
Cleared Mar 03, 1995
SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER
K950094 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 52d
Cleared Mar 03, 1995
CK QVET
K950177 · CGS
Prisma Systems
Chemistry · 45d
Cleared Mar 03, 1995
ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEM
K950297 · GCJ
Argus Medical Co., Inc.
General & Plastic Surgery · 37d
Cleared Mar 02, 1995
ACUSON MODEL 3001
K935595 · ITX
Acuson Corp.
Radiology · 468d
Cleared Mar 02, 1995
605 VACU-MAX
K941961 · BTA
Medical Industries America, Inc.
General & Plastic Surgery · 314d
Cleared Mar 02, 1995
V5M
K942296 · ITX
Acuson Corp.
Radiology · 294d
Cleared Mar 02, 1995
KT1000/S KNEE LIGAMENT ARTHROMETER
K943197 · LYH
Medmetric Corp.
Neurology · 240d
Cleared Mar 02, 1995
R&D BATTERIES PART NOS. 5186 AND 5230
K944387 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 176d
Cleared Mar 02, 1995
SEALDENT
K944466 · EBI
Scientific Pharmaceuticals, Inc.
Dental · 176d
Cleared Mar 02, 1995
S & S ORTHOPEDIC WIRE DRIVER 701
K944488 · KIJ
S & S Orthopedic , Ltd.
Orthopedic · 170d
Cleared Mar 02, 1995
HERNIA MESH INTRODUCTION SYSTEM
K945060 · FTL
Gerard Medical, Inc.
General & Plastic Surgery · 139d
Cleared Mar 02, 1995
POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES
K945767 · LYY
Ansell, Inc.
General Hospital · 101d
Cleared Mar 02, 1995
WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT
K945877 · HJM
Wells Johnson Co.
Ophthalmic · 91d
Cleared Mar 02, 1995
METAL FRAME, PLASTIC FRAME
K945895 · HQY
Sun Vista Intl., Inc.
Ophthalmic · 90d
Cleared Mar 02, 1995
MEDICAL IMAGE MANAGEMENT SYSTEM (MIM)
K946117 · LLZ
Siemens Medical Solutions Health...
Radiology · 77d
Cleared Mar 02, 1995
KARL STORZ BOUGIES, SOUNDS, DILATORS
K946331 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 63d
Cleared Mar 02, 1995
SILHOUETTE SUNLIMITED ADIDAS
K950519 · HQY
Silhouette Optical , Ltd.
Ophthalmic · 24d
Cleared Mar 02, 1995
SUNGLASSES
K950526 · HQY
Tony Optical Enterprises Co., Ltd.
Ophthalmic · 28d
Cleared Mar 02, 1995
STORS SCLERAL SPONGE II (LINCOFF DESIGN)
K950599 · HQX
Storz Ophthalmics, Inc.
Ophthalmic · 21d
Cleared Mar 02, 1995
DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION
K950608 · IZH
Lorad Corp.
Radiology · 21d
Cleared Mar 02, 1995
ORVIS KEY WEST SUNGLASSES
K950609 · HQY
The Orvis Co., Inc.
Ophthalmic · 20d
Cleared Mar 02, 1995
MANAN SUPER-CORE BIOPSY NEEDLE
K950732 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 14d