FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
121945–121968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1991
HYPERGEL PROTECTIVE WOUND GEL
K905439 · KMF
Scott Health Care
General & Plastic Surgery · 176d
Cleared May 29, 1991
SGARLATO FLEXIBLE HINGE TOE IMPLANT
K905795 · KWH
Sgarlato Laboratories, Inc.
Orthopedic · 153d
Cleared May 29, 1991
AVD INTIMAX OCCLUSION CATHETER
K910339 · DQT
Applied Vascular Devices, Inc.
Cardiovascular · 121d
Cleared May 29, 1991
DCW MODULAR DISTAL FEMORAL SYSTEM
K910596 · KRO
Dow Corning Wright
Orthopedic · 106d
Cleared May 29, 1991
ALPHA-FIL, ALPHA-BASE & ALPHA-SILVER, MODIFICATION
K910627 · EBF
Foremost Mfg., Inc.
Dental · 127d
Cleared May 29, 1991
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K910873 · DXT
Bd Becton Dickinson Vacutainer...
Cardiovascular · 89d
Cleared May 29, 1991
7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE
K910987 · DQO
Scimed
Cardiovascular · 83d
Cleared May 29, 1991
LIGAMENTOPLASTIC STAPLE OF L'UNION
K911020 · JDR
Sport Service, Inc.
Orthopedic · 89d
Cleared May 29, 1991
PLATE BLADE WITH CURSOR OF L'UNION
K911021 · KTT
Sport Service, Inc.
Orthopedic · 89d
Cleared May 29, 1991
STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION
K911026 · JDR
Sport Service, Inc.
Orthopedic · 89d
Cleared May 29, 1991
THE TRAMOND PIN
K911031 · JDR
Sport Service, Inc.
Orthopedic · 89d
Cleared May 29, 1991
GAMMAT ELECTROFORMED GOLD COPING
K911042 · EJT
Gramm Surface Technology, Inc.
Dental · 82d
Cleared May 29, 1991
STEALTH CATHETER SYSTEM
K911089 · LIT
Target Therapeutics
Cardiovascular · 85d
Cleared May 29, 1991
POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM
K911151 · ITI
Tarsys Engineering, Inc.
Physical Medicine · 75d
Cleared May 29, 1991
NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS
K911227 · DTZ
3M Health Care, Sarns
Cardiovascular · 70d
Cleared May 29, 1991
ADHESIVE PRECOATED BRACKETS
K911271 · DYH
Unitek Corp.
Dental · 68d
Cleared May 29, 1991
PALFIQUE ESTELITE
K911524 · EBF
Tokuyama America, Inc.
Dental · 54d
Cleared May 29, 1991
MEDTRACK TREADMILL
K911751 · IOL
Quinton, Inc.
Physical Medicine · 41d
Cleared May 28, 1991
ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE
K901811 · BSP
Neuro Technology
Anesthesiology · 403d
Cleared May 28, 1991
SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT
K904165 · JXE
Occupational Preventive Diagnostics,...
Neurology · 259d
Cleared May 28, 1991
AMBU MATIC AUTOMATIC RESUSCITATOR
K904920 · BTL
Ambu, Inc.
Anesthesiology · 209d
Cleared May 28, 1991
MX CYCLER
K905071 · EKX
Dakmed, Inc.
Dental · 200d
Cleared May 28, 1991
SATLITE PLUS PULSE OXIMETER
K905140 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 194d
Cleared May 28, 1991
MINIOX V PULSE OXIMETER
K905310 · DQA
Catalyst Research Corp.
Anesthesiology · 181d