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
81529–81552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2000
CBS STRAW
K002595 · MQG
Cryo Bio System
Obstetrics & Gynecology · 88d
Cleared Nov 17, 2000
CN ACQUISITION STATION
K002597 · LLZ
Cardionow, Inc.
Radiology · 88d
Cleared Nov 17, 2000
DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
K002692 · FRF
Hmi Industries, Inc.
General Hospital · 80d
Cleared Nov 17, 2000
RACE ENDODONTIC FILE
K002709 · EFA
Amc General, Inc.
Dental · 79d
Cleared Nov 17, 2000
NUMALINK
K002724 · LLZ
Numa, Inc.
Radiology · 78d
Cleared Nov 17, 2000
VIATRONIX VISUALIZATION SYSTEM (VVS)
K002780 · LLZ
Viatronix, Inc.
Radiology · 72d
Cleared Nov 17, 2000
BIOSENSORS CENTRAL VENOUS CATHETER KITS
K002786 · FOZ
Sunscope Intl., Inc.
General Hospital · 71d
Cleared Nov 17, 2000
MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM
K002840 · IZI
The Phantom Laboratory, Inc.
Radiology · 66d
Cleared Nov 17, 2000
GALAXY
K003007 · EJT
Sterngold
Dental · 52d
Cleared Nov 17, 2000
DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE,...
K003132 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 42d
Cleared Nov 17, 2000
RESUSCITAIRE RADIANT WARMER
K003335 · FMT
Hill-Rom Air-Shields
General Hospital · 23d
Cleared Nov 17, 2000
CT CORD IQ OPTION 1.0
K003408 · JAK
GE Medical Systems
Radiology · 15d
Cleared Nov 17, 2000
TISSUE SPECTROSCOPE
K992529 · DPW
Vital Medical , Ltd.
Cardiovascular · 478d
Cleared Nov 16, 2000
SILENT NIGHT V
K000253 · MNR
Sleep Solutions, Inc.
Anesthesiology · 294d
Cleared Nov 16, 2000
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · DXT
Medrad, Inc.
Cardiovascular · 169d
Cleared Nov 16, 2000
BEHRING COAGULATION SYSTEM, MODEL BCS
K002080 · JPA
Dade Behring, Inc.
Hematology · 129d
Cleared Nov 16, 2000
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
K002447 · DKZ
American Bio Medica Corp.
Toxicology · 99d
Cleared Nov 16, 2000
MULITPLE MALE LATX CONDOM
K002571 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 90d
Cleared Nov 16, 2000
MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002,...
K002572 · GWG
Medtronic PS Medical
Neurology · 90d
Cleared Nov 16, 2000
ADVANCED UROSCIENCE INNERSHEATH
K002573 · FBK
Advanced Uroscience, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 16, 2000
ECAT ACCEL PET SCANNER
K002584 · KPS
Cti Pet Systems, Inc.
Radiology · 87d
Cleared Nov 16, 2000
INVAC
K002608 · IYE
Duncan Hynd Associates, Ltd.
Radiology · 87d
Cleared Nov 16, 2000
NEWGEN SYSTEM
K002619 · JEY
Stryker Instruments
Dental · 85d
Cleared Nov 16, 2000
SURESMILE SYSTEM
K002620 · EIA
Orametrix, Inc.
Dental · 85d