FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76873–76896 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2002
PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM
K014159 · DSI
Philips Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 18, 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K014184 · FGE
Guidant Corp.
Gastroenterology & Urology · 29d
Cleared Jan 18, 2002
PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS
K014209 · MKJ
Padpro, LLC
Cardiovascular · 28d
Cleared Jan 18, 2002
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
K014222 · GEI
Arthrocare Corp.
General & Plastic Surgery · 23d
Cleared Jan 18, 2002
BIO SPA INTELLIGENT
K992099 · IPF
Starbene
Physical Medicine · 942d
Cleared Jan 17, 2002
BIOLIGHT PCD
K011355 · ILY
Biolight International AB
Physical Medicine · 259d
Cleared Jan 17, 2002
RANDOX THEOPHYLLINE
K011771 · KLS
Randox Laboratories, Ltd.
Chemistry · 225d
Cleared Jan 17, 2002
DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
K011839 · EBF
Doxa Certex AB
Dental · 219d
Cleared Jan 17, 2002
ECG HOME
K012012 · DXH
H&C Medical Devices Spa
Cardiovascular · 203d
Cleared Jan 17, 2002
HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
K012037 · CAW
Airsep Corp.
Anesthesiology · 202d
Cleared Jan 17, 2002
VAMOS ANESTHETIC GAS MONITOR
K012139 · CCK
Draeger Medical, Inc.
Anesthesiology · 191d
Cleared Jan 17, 2002
ERCHONIA PL2000
K012580 · NHN
Tuco Innovations, Inc.
Physical Medicine · 161d
Cleared Jan 17, 2002
INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325
K012759 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 153d
Cleared Jan 17, 2002
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
K012789 · JHO
Morax
Chemistry · 150d
Cleared Jan 17, 2002
PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
K012804 · MVA
Scott E Allen CP
Neurology · 149d
Cleared Jan 17, 2002
EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
K012879 · FPA
Exelint Intl. Co.
General Hospital · 142d
Cleared Jan 17, 2002
DILATING TIP OBTURATOR
K012884 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 142d
Cleared Jan 17, 2002
MODIFICATION OF NC-STAT
K013459 · JXE
Neurometrix, Inc.
Neurology · 91d
Cleared Jan 17, 2002
SWIFT LOW PROFILE CUP (PRO CUP)
K013460 · HDB
Swift Delivery Products
Obstetrics & Gynecology · 91d
Cleared Jan 17, 2002
NLITE SYSTEM,MODEL A00-1025
K013461 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 91d
Cleared Jan 17, 2002
TOCO LITE, MODEL TD-01
K013477 · HFM
Ventrex, Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 17, 2002
MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH...
K013485 · DXN
Microlife Corp.
Cardiovascular · 90d
Cleared Jan 17, 2002
CEMENTED CALCAR HIP SYSTEM
K013490 · LPH
Encore Orthopedics, Inc.
Orthopedic · 87d
Cleared Jan 17, 2002
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN...
K013498 · LYY
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 87d