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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76369–76392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 17, 2002
DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
K013513 · HRX
Pain Concepts, Inc.
Orthopedic · 87d
Cleared Jan 17, 2002
SIMPLE
K013519 · KLE
Bisco, Inc.
Dental · 86d
Cleared Jan 17, 2002
ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
K013539 · DXN
Rossmax International , Ltd.
Cardiovascular · 85d
Cleared Jan 17, 2002
POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN...
K013554 · LYY
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 84d
Cleared Jan 17, 2002
MAGICFIL
K013571 · EBF
Dmg USA, Inc.
Dental · 80d
Cleared Jan 17, 2002
ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE...
K013583 · DXN
Rossmax International , Ltd.
Cardiovascular · 79d
Cleared Jan 17, 2002
PERMACOL
K013625 · FTM
Tissue Science Laboratories, Plc
General & Plastic Surgery · 73d
Cleared Jan 17, 2002
GLOBAL HEALTHCARE VAGINAL SPECULUM
K013835 · HIB
Dynascend Consulting Int'L, LLC
Obstetrics & Gynecology · 59d
Cleared Jan 17, 2002
3DFIS, MODEL IES-FL-101
K013841 · LLZ
3Dsharp, Inc.
Radiology · 58d