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
144769–144792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1986
CURITY FIBEROPTIC INTUBATING AIRWAY
K855137 · CAE
The Kendal Co.
Anesthesiology · 78d
Cleared Mar 11, 1986
ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY
K855142 · FGE
Angiomed U.S., Inc.
Gastroenterology & Urology · 75d
Cleared Mar 11, 1986
ANGIOMED EXCHANGE DRAINAGE CATHETER SETS
K855143 · KOD
Angiomed U.S., Inc.
Gastroenterology & Urology · 75d
Cleared Mar 11, 1986
MENTOR SINGLE COIL URINARY DIVERSION STENT SET
K860055 · FAD
Mentor Corp.
Gastroenterology & Urology · 64d
Cleared Mar 11, 1986
NEISSERIASTAT
K860156 · JTO
Richardson Scientific, Inc.
Microbiology · 54d
Cleared Mar 11, 1986
THE HOLTER REPORTER (TM)
K860249 · DPS
Applied Cardiac Systems
Cardiovascular · 46d
Cleared Mar 11, 1986
API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC
K860369 · JWY
Analytical Products, Inc.
Microbiology · 36d
Cleared Mar 11, 1986
CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
K860484 · KOD
The Kendal Co.
Gastroenterology & Urology · 29d
Cleared Mar 11, 1986
MENTOR CORPORAL DILATORS
K860517 · FAE
Mentor Corp.
Gastroenterology & Urology · 28d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS RIFAMPIN 15 MCG
K860560 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS PENICILLIN G 2 UNITS
K860561 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS COLISTIN 10 MCG
K860562 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS VANCOMYCIN 5 MCG
K860563 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS ERYTHROMYCIN 60 MCG
K860564 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS KANAMYCIN 1000 MCG
K860565 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 11, 1986
ETHOX LAVAGE TUBE
K860599 · KDH
Ethox Corp.
Gastroenterology & Urology · 20d
Cleared Mar 11, 1986
OFPBL
K860707 · JSI
Remel Co.
Microbiology · 13d
Cleared Mar 10, 1986
XISCAN MODEL 1000
K852346 · JAA
Xi Tech
Radiology · 283d
Cleared Mar 10, 1986
SONOLINE CD
K852686 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 258d
Cleared Mar 10, 1986
SONOLINE SX ULTRASOUND SCANNER
K852739 · DXK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 256d
Cleared Mar 10, 1986
DIMENSION TOTAL HIP PROSTHESIS POROUS COATED
K854107 · JDL
Kirschner Medical Corp.
Orthopedic · 153d
Cleared Mar 10, 1986
DIGIRAD REUSABLE IMAGE MEDIA
K854407 · LQA
Digirad Corp.
Radiology · 129d
Cleared Mar 10, 1986
INLAY WAX REGULAR
K854529 · EGD
The Hygenic Corp.
Dental · 117d
Cleared Mar 10, 1986
SOLAR F
K854641 · EIA
Alpine Dental Equipment Co.
Dental · 111d