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
99817–99840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1995
ANTHOS 2010 READER
K955077 · JJQ
Anthos Labtec, Inc.
Chemistry · 28d
Cleared Dec 04, 1995
TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY
K955272 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 19d
Cleared Dec 01, 1995
ORTHOPEDIC PACKS
K951231 · GAN
Sterile Concepts, Inc.
General & Plastic Surgery · 256d
Cleared Dec 01, 1995
OPTICAL BLANKS: BENZ55G CLEAR AND VISIBILITY TINTED
K952620 · LPL
Benz Research and Development Corp.
Ophthalmic · 178d
Cleared Dec 01, 1995
SYRINGE MAGNIFIER
K953626 · FMF
Innovative Premiums, Inc.
General Hospital · 121d
Cleared Dec 01, 1995
ROOT CANAL LENGTH MEASURING DEVICE
K953867 · LQY
J. Morita USA, Inc.
Dental · 106d
Cleared Dec 01, 1995
IMPREGUM PENTA
K954192 · ELW
Espe GmbH & Co. Kg.
Dental · 86d
Cleared Dec 01, 1995
EVOLUTION PHACOMULSIFIER
K954240 · HQC
U.S. Iol, Inc.
Ophthalmic · 81d
Cleared Dec 01, 1995
SURGIN GENISIS PHACOEMULSIFIER
K954241 · HQC
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 81d
Cleared Dec 01, 1995
CIRCUIT TREE PHACOEMULSIFIER
K954242 · HQC
Circuit Tree
Ophthalmic · 81d
Cleared Dec 01, 1995
CELSITE VENOUS ACCESS SYSTEM OTW
K954297 · LJT
B.Braun Medical, Inc.
General Hospital · 78d
Cleared Dec 01, 1995
FOCUS PC BALLOON DILATATION CATHETER
K954313 · LIT
Cardio-Dynamics, Inc.
Cardiovascular · 77d
Cleared Dec 01, 1995
ANGIOPTIC ANGIOGRAPHIC CATHETER
K954423 · DQO
AngioDynamics, Inc.
Cardiovascular · 71d
Cleared Dec 01, 1995
DRAGER PT4000 PHOTOTHERAPY SYSTEM
K954611 · LBI
Drager, Inc.
General Hospital · 58d
Cleared Dec 01, 1995
KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
K954780 · HKI
Kowa Optimed, Inc.
Ophthalmic · 45d
Cleared Dec 01, 1995
KOWA GENESIS HAND-HELD FUNDUS CAMERA
K954781 · HKI
Kowa Optimed, Inc.
Ophthalmic · 45d
Cleared Dec 01, 1995
PULPDENT RESILUTE
K955017 · EMA
Pulpdent Corp.
Dental · 29d
Cleared Dec 01, 1995
DEGUBOND X-LITE
K955027 · EJT
Degussa Corp.
Dental · 29d
Cleared Dec 01, 1995
TITANIUM BIRD BEAK PLIER
K955242 · JEX
Sybron Dental Specialties, Inc.
Dental · 16d
Cleared Nov 30, 1995
CYSTOSCOPE
K941992 · FBO
Surgical Technologies, Inc.
Gastroenterology & Urology · 584d
Cleared Nov 30, 1995
PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS
K950602 · FJI
Reprocessing Products Corp
Gastroenterology & Urology · 294d
Cleared Nov 30, 1995
RS-4M
K953136 · IPF
Rs Medical
Physical Medicine · 147d
Cleared Nov 30, 1995
OSTEO-RAY 100
K953404 · IZL
Micro-Focus Imaging., Inc.
Radiology · 133d
Cleared Nov 30, 1995
DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM
K953651 · DRF
Arrow Intl., Inc.
Cardiovascular · 118d