Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
70897–70920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 12, 2003
Y.E.S POWERED WHEELCHAIR. T180
K032512 · ITI
Yeou Eir Shuen Machinery Co., Ltd.
Physical Medicine · 90d
Cleared Nov 12, 2003
ENDO PAT 2000
K032519 · DQK
Itamar Medical
Cardiovascular · 89d
Cleared Nov 12, 2003
ORTRAUTEK TRAUMA SYSTEM
K032520 · JEY
Tekka
Dental · 89d
Cleared Nov 12, 2003
WU'S 4-WHEELED SCOOTER, WT-L4JR
K032617 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 79d
Cleared Nov 12, 2003
ULTRADENT CITRIC ACID 10% SOLUTION
K032627 · KJJ
Ultradent Products, Inc.
Dental · 78d
Cleared Nov 12, 2003
ELECSYS PROBNP IMMUNOASSAY
K032646 · NBC
Roche Diagnostics Corp.
Chemistry · 77d
Cleared Nov 12, 2003
Y.E.S. POWERED WHEELCHAIR, MODEL T200
K032669 · ITN
Yeou Eir Shuen Machinery Co., Ltd.
Physical Medicine · 76d