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
125761–125784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1990
ENTERA-FLO FEEDING TUBE
K901130 · KNT
Fresenius Pharma
Gastroenterology & Urology · 81d
Cleared Jun 01, 1990
RIGID URETEROSCOPE
K901214 · FGB
Applied Urology, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 01, 1990
SPEC(TM) EXTRACTION CARTRIDGE
K901694 · DKE
Toxi-Lab, Inc.
Toxicology · 52d
Cleared Jun 01, 1990
600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET
K901753 · KNT
Chartermed, Inc.
Gastroenterology & Urology · 46d
Cleared Jun 01, 1990
URESIL TRU-CLOSE DRAINAGE BAG
K901844 · EXF
Uresil Corp.
Gastroenterology & Urology · 38d
Cleared Jun 01, 1990
VIVAALLOY HR (AMALGAM)
K901911 · EJJ
Ivoclar North America, Inc.
Dental · 36d
Cleared Jun 01, 1990
CP-3 DENTAL POLISHING MATERIAL
K901973 · EJR
Gresco Products, Inc.
Dental · 31d
Cleared Jun 01, 1990
FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR
K901996 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 01, 1990
PATHODX PYR KIT
K902037 · JTO
Diagnostic Products Corp.
Microbiology · 28d
Cleared Jun 01, 1990
NA LATEX MYOGLOBIN TEST
K902154 · DDR
Behring Diagnostics, Inc.
Immunology · 17d
Cleared Jun 01, 1990
MODIFIED NON-STERILE LATEX EXAMINATION GLOVES
K902181 · LYY
Aladan Corp.
General Hospital · 30d
Cleared Jun 01, 1990
MODIFIED STERILE LATEX EXAMINATION GLOVES
K902182 · LYY
Aladan Corp.
General Hospital · 30d
Cleared May 31, 1990
GUT SUTURES
K896554 · GAL
Look, Inc.
General & Plastic Surgery · 195d
Cleared May 31, 1990
A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)
K897195 · EKS
A Company, Inc.
Dental · 153d
Cleared May 31, 1990
INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)
K900096 · EWO
Artifical Hearing Systems Corp.
Ear, Nose, Throat · 143d
Cleared May 31, 1990
ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES
K900178 · EFS
Core-Vent Corp.
Dental · 135d
Cleared May 31, 1990
COOK STEREOTAXIC GUIDE
K900200 · HAW
Cook, Inc.
Neurology · 135d
Cleared May 31, 1990
ENZYMUN TEST(R) DIGOXIN
K901216 · KXT
Boehringer Mannheim Corp.
Toxicology · 78d
Cleared May 31, 1990
STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
K901301 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 72d
Cleared May 31, 1990
THE HUESTIS COMPU-PLOTTER
K901567 · IXI
Huestis Machine Corp.
Radiology · 58d
Cleared May 31, 1990
OCULAR INFUSION CANNULA SYSTEM
K901618 · HMX
Tamcenan Corp.
Ophthalmic · 55d
Cleared May 31, 1990
KESTREL LENS CASE (208-12NT POLYSTYRENE)
K901748 · LRX
Kestrel
Ophthalmic · 44d
Cleared May 31, 1990
MODEL 4050-21
K901864 · LNH
Medical Advances, Inc.
Radiology · 36d
Cleared May 31, 1990
NEOCOAT T4
K901939 · CDX
Neometrics, Inc.
Chemistry · 31d