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
105361–105384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1994
PRODIGY
K944659 · EBF
Sybron Dental Specialties, Inc.
Dental · 78d
Cleared Dec 08, 1994
COULTER FLOW SET
K944751 · JPK
Coulter Corp.
Hematology · 73d
Cleared Dec 08, 1994
P.F.C. APICAL PLUG
K944769 · JDL
Johnson & Johnson Professionals, Inc.
Orthopedic · 72d
Cleared Dec 08, 1994
CYPRESS MEDICAL PRODUCTS STETHOSCOPE
K945082 · LDE
Cypress Medical Products, Ltd.
Cardiovascular · 52d
Cleared Dec 08, 1994
TRELEX NATURAL(R) MESH
K945377 · FTL
Meadox Medicals, Div. Boston...
General & Plastic Surgery · 45d
Cleared Dec 08, 1994
CHAKOFF ENDOSCOPY
K945420 · FCW
Stephen Chakoff, Inc.
Gastroenterology & Urology · 34d
Cleared Dec 08, 1994
LATEX EXAMINATION GLOVE
K945490 · LYY
Masif Healthcare Products Sdn. Bhd.
General Hospital · 30d
Cleared Dec 08, 1994
CANDELA ELLIPTICAL SPOT HANDPIECE
K945587 · GEX
Candela Laser Corp.
General & Plastic Surgery · 24d
Cleared Dec 08, 1994
ELECTROSURGICAL ENDOSCOPIC CORD
K945717 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 17d
Cleared Dec 07, 1994
DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
K924277 · HLT
Chalgren Enterprises, Inc.
Ophthalmic · 834d
Cleared Dec 07, 1994
COMFIT BLUE POWDERED EXAMINATION GLOVES
K936268 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 342d
Cleared Dec 07, 1994
FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01
K940085 · LXM
Sense Technology, Inc.
Physical Medicine · 334d
Cleared Dec 07, 1994
DIAGNOSTIC ULTRASOUND IMAGING CATHETER
K940108 · ITX
Boston Scientific Corp
Radiology · 331d
Cleared Dec 07, 1994
CANDELA Q-SWITCHED ALEXANDRITE LASER
K940173 · GEX
Candela Laser Corp.
General & Plastic Surgery · 330d
Cleared Dec 07, 1994
FAST-PATCH
K941970 · MKJ
Physio-Control Corp.
Cardiovascular · 229d
Cleared Dec 07, 1994
POWDER-FREE LATEX EXAMINATION GLOVES
K942856 · LYY
Pacificlink Exp.Industries Private ,...
General Hospital · 174d
Cleared Dec 07, 1994
MEDVISION ENVIROMENT/MEDVISION 2.0
K942861 · LMD
Evergreen Technologies, Inc.
Radiology · 173d
Cleared Dec 07, 1994
GGT QVET
K942962 · JQB
Prisma Systems
Chemistry · 167d
Cleared Dec 07, 1994
CHLORIDE QVET
K943006 · CHJ
Prisma Systems
Chemistry · 167d
Cleared Dec 07, 1994
HDL QVET
K943028 · LBS
Prisma Systems
Chemistry · 163d
Cleared Dec 07, 1994
MOTORIZED DEPTH DOSE APPARATUS
K943199 · IYE
Medtec, Inc.
Radiology · 155d
Cleared Dec 07, 1994
VISUALINE II HCG
K943239 · JHI
Sun Biomedical Laboratories, Inc.
Chemistry · 154d
Cleared Dec 07, 1994
PANORAMIC CORPORATION HDLX
K943532 · JAA
Panoramic Corp.
Radiology · 139d
Cleared Dec 07, 1994
ULTRA-LINE RONGEUR
K943635 · HAE
V. Mueller Neuro/Spine
Neurology · 133d