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
69769–69792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2003
DENTATUS OSCIOMAT
K031793 · DZH
Dentatus USA , Ltd.
Dental · 156d
Cleared Nov 13, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR...
K032444 · LZC
Cardinalhealth
General Hospital · 97d
Cleared Nov 13, 2003
PROFILE BBL SYSTEM
K032460 · GEX
Sciton, Inc
General & Plastic Surgery · 94d
Cleared Nov 13, 2003
NUVASIVE MESH
K032476 · MQP
Nuvasive, Inc.
Orthopedic · 93d
Cleared Nov 13, 2003
ZOLL AUTOCLAVABLE INTERNAL HANDLES
K032691 · LDD
Zoll Medical Corp
Cardiovascular · 72d
Cleared Nov 13, 2003
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K032744 · JCT
Alveolus, Inc.
General & Plastic Surgery · 70d
Cleared Nov 13, 2003
BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K032781 · LYZ
Zibo Blue Sail Plastic & Rubber...
General Hospital · 66d
Cleared Nov 13, 2003
BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
K032783 · LYZ
Zibo Blue Sail Plastic & Rubber...
General Hospital · 66d
Cleared Nov 13, 2003
HOSPITAL SPACER
K032809 · CAF
Respironics Healthscan, Inc.
Anesthesiology · 65d
Cleared Nov 13, 2003
STELKAST UNICONDYLAR KNEE SYSTEM
K032824 · HSX
Stelkast Company
Orthopedic · 64d
Cleared Nov 13, 2003
NAVIGATOR I
K032879 · INI
Adaptive Healthcare Technologies, Inc.
Physical Medicine · 59d
Cleared Nov 13, 2003
PREMISE
K032921 · EBF
Sybron Dental Specialties, Inc.
Dental · 52d
Cleared Nov 13, 2003
MPS ACACIA SAFEGUARD HUBER DEVICE
K032934 · FPA
Mps Acacia
General Hospital · 52d
Cleared Nov 13, 2003
EXACTECH 12/14 ALUMINA FEMORAL HEAD
K032964 · LPH
Exactech, Inc.
Orthopedic · 51d
Cleared Nov 13, 2003
DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES
K033144 · MKJ
Defibtech, LLC
Cardiovascular · 44d
Cleared Nov 13, 2003
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K033252 · HWC
Stryker Endoscopy
Orthopedic · 36d
Cleared Nov 13, 2003
MONOJECT INSULIN SYRINGE
K033373 · FMI
Tyco Healthcare
General Hospital · 22d
Cleared Nov 13, 2003
APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82
K033446 · EJT
We Dong Myung Dental Industrial Co.,...
Dental · 15d
Cleared Nov 12, 2003
OXYCON MOBILE
K023120 · BZC
Erich Jaeger GmbH
Anesthesiology · 419d
Cleared Nov 12, 2003
DOC'S BEST WHITE COPPER CEMENT
K031494 · EMA
Cooley & Cooley, Ltd.
Dental · 183d
Cleared Nov 12, 2003
RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
K031559 · JOW
Renu Medical, Inc.
Cardiovascular · 177d
Cleared Nov 12, 2003
GOOD MORNING TEST
K031798 · LCX
Standard Diagnostics, Inc.
Chemistry · 155d
Cleared Nov 12, 2003
MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
K031799 · LDS
Miele, Inc.
General Hospital · 155d
Cleared Nov 12, 2003
ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660
K031820 · IPF
Multinational
Physical Medicine · 153d