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
121009–121032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1991
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K911806 · LNH
General Electric Co.
Radiology · 66d
Cleared Jun 28, 1991
TEMPERLITE(TM) SAW BLADE
K911902 · HSD
Sierra Surgical, Inc.
Orthopedic · 63d
Cleared Jun 28, 1991
MAXI-SCOPE OR ULTRA-SCOPE
K912128 · LDE
Seiichi Mfg., Inc.
Cardiovascular · 45d
Cleared Jun 28, 1991
OLDELFT SIMULIX-MC
K912466 · KPQ
Oldelft Corp. of America
Radiology · 24d
Cleared Jun 27, 1991
ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
K905569 · GZB
Biomedical Life Systems, Inc.
Neurology · 197d
Cleared Jun 27, 1991
KEANE UNI KNEE SYSTEM
K910807 · HSX
Depuy, Inc.
Orthopedic · 121d
Cleared Jun 27, 1991
NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER
K910890 · LYU
Lovell-Schenck, Inc.
General Hospital · 128d
Cleared Jun 27, 1991
INERPAN(TM) TEMPORARY WOUND DRESSING
K911161 · MGP
Laboratories Delalande
General & Plastic Surgery · 104d
Cleared Jun 27, 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398 · HWC
Howmedica Corp.
Orthopedic · 90d
Cleared Jun 27, 1991
SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
K911628 · LIF
Serim Research Corp.
Gastroenterology & Urology · 77d
Cleared Jun 27, 1991
SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
K911629 · LIF
Serim Research Corp.
Gastroenterology & Urology · 77d
Cleared Jun 27, 1991
CERAPALL 2
K911668 · EJS
Metalor Dental USA Corp.
Dental · 77d
Cleared Jun 27, 1991
PAGALIN 2
K911675 · EJS
Metalor Dental USA Corp.
Dental · 77d
Cleared Jun 27, 1991
SELECTOR 3
K911677 · EJS
Metalor Dental USA Corp.
Dental · 77d
Cleared Jun 27, 1991
BIOMET COBALT-CHROME FEMORAL COMPONENTS
K911684 · JDI
Biomet, Inc.
Orthopedic · 72d
Cleared Jun 27, 1991
LATEX PATIENT EXAMINATION GLOVES, HYPOALLERGENIC
K912083 · LYY
Sterigard, Inc.
General Hospital · 51d
Cleared Jun 27, 1991
INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
K912252 · FST
Fiberoptic Medical Products, Inc.
General & Plastic Surgery · 37d
Cleared Jun 26, 1991
MAICO MA800 AUDIOMETER
K911368 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 90d
Cleared Jun 26, 1991
OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
K911373 · HRY
Osteonics Corp.
Orthopedic · 90d
Cleared Jun 26, 1991
SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID
K911810 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 26, 1991
SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID
K911811 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 26, 1991
VS1G
K912297 · EJT
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
VS1
K912298 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
VS1B
K912299 · EJS
Metalor Dental USA Corp.
Dental · 36d