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
121345–121368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1991
FACEPLATE ITE HEARING AID MODEL 28A
K910901 · LRB
Telex Communications, Inc.
Ear, Nose, Throat · 86d
Cleared May 30, 1991
JAIN QUICK COUNT
K911076 · MMK
Jain Surgical Equipment, Inc.
General Hospital · 80d
Cleared May 30, 1991
PULPDENT DIAMOND POLISH
K911284 · EJR
Pulpdent Corp.
Dental · 90d
Cleared May 30, 1991
MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION
K911642 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared May 30, 1991
ZEFON BATERIAL/VIRAL FILTER
K911651 · CAH
Bill Olson Corp.
General Hospital · 48d
Cleared May 30, 1991
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE
K911667 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 48d
Cleared May 30, 1991
THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST
K911821 · EJH
Dentecon, Inc.
Dental · 36d
Cleared May 30, 1991
ZERO-G(TM) GEL/FOAM MATTRESS TOPPER
K911843 · KIC
Steridyne Corp.
Physical Medicine · 35d
Cleared May 30, 1991
BARD SINGULAR BIOPSY FORCEPS
K912214 · FCL
C.R. Bard, Inc.
Gastroenterology & Urology · 10d
Cleared May 29, 1991
VENA CAVA FILTER
K901454 · DTK
Vena-Tech, Inc.
Cardiovascular · 428d
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