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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
36361–36384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2014
FLEX-MT +
K140467 · IPF
Emsi
Physical Medicine · 225d
Cleared Oct 07, 2014
A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR
K141160 · DXN
A & D Co., Ltd.
Cardiovascular · 155d
Cleared Oct 07, 2014
EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K141510 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 120d
Cleared Oct 07, 2014
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
K141623 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 112d
Cleared Oct 07, 2014
VASSEN COLOR
K141699 · LPL
Vassen Co., Ltd.
Ophthalmic · 105d
Cleared Oct 07, 2014
RESIDUAL LIMB LENGTHENING SYSTEM
K141739 · HSB
Ellipse Technologies, Inc.
Orthopedic · 102d
Cleared Oct 07, 2014
888 WNLE POWERED WHEELCHAIR
K142027 · ITI
Pihsiang Machinery Mfg. Co., Ltd.
Physical Medicine · 74d
Cleared Oct 07, 2014
Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
K142275 · LPL
Neo Vision Co., Ltd.
Ophthalmic · 53d
Cleared Oct 07, 2014
First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
K142353 · DIO
W.H.P.M., Inc.
Toxicology · 47d
Cleared Oct 06, 2014
APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
K141522 · BZD
Apex Medical Corp.
Anesthesiology · 119d
Cleared Oct 06, 2014
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704 · LYA
Medtronic, Inc.
Ear, Nose, Throat · 104d
Cleared Oct 06, 2014
ULTRASHAPE SYSTEM
K141708 · OHV
Syneron Medical, Ltd.
General & Plastic Surgery · 104d
Cleared Oct 06, 2014
STARBAND, STARLIGHT
K141842 · MVA
Orthomerica Products, Inc.
Neurology · 90d
Cleared Oct 06, 2014
SHARKCORE FINE NEEDLE BIOPSY SYSTEM
K141894 · FCG
Covidien, LLC( Formerly Beacon...
Gastroenterology & Urology · 84d
Cleared Oct 06, 2014
DIODE LASER HAIR REMOVAL SYSTEM
K141973 · GEX
Beijing Anchorfree Technology Co., Ltd.
General & Plastic Surgery · 77d
Cleared Oct 06, 2014
LiNA SafeAir Smoke Pencil
K142538 · GEI
Lina Medical Aps
General & Plastic Surgery · 27d
Cleared Oct 03, 2014
MSA100 PEAK FLOW METER
K133975 · BZH
Beijing M&B Electronic Instruments...
Anesthesiology · 281d
Cleared Oct 03, 2014
FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
K140062 · NVP
Fsc Laboratories, Inc.
Anesthesiology · 266d
Cleared Oct 03, 2014
CRANIOPLUG
K140309 · GXR
Ossdsign AB
Neurology · 238d
Cleared Oct 03, 2014
MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC
K140605 · NHJ
Dima Italia Srl
Anesthesiology · 207d
Cleared Oct 03, 2014
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
K141139 · NCX
Zoll Circulation
Neurology · 154d
Cleared Oct 03, 2014
FORUM GLAUCOMA WORKPLACE
K141297 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 137d
Cleared Oct 03, 2014
HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
K141502 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 119d
Cleared Oct 03, 2014
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
K141743 · MQB
Radiology Solutions, LLC
Radiology · 95d