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
40225–40248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2013
PADSCAN HD SERIES BLADDER SCANNER
K131227 · IYO
Carenoso Technology Co., Ltd.
Radiology · 73d
Cleared Jul 12, 2013
FACET FIXX
K131417 · MRW
Nexxt Spine, LLC
Orthopedic · 57d
Cleared Jul 12, 2013
MIPLATFORM MEDICAL IMAGING SUITE
K131424 · LLZ
Hinacom Software and Technology, Ltd.
Radiology · 56d
Cleared Jul 12, 2013
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K131514 · IYN
Ge Vingmed Ultrasound AS
Radiology · 45d
Cleared Jul 12, 2013
LANX FUSION SYSTEM
K131547 · OVD
Lanx, Inc.
Orthopedic · 44d
Cleared Jul 12, 2013
ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
K131637 · GDW
Rotation Medical, Inc.
General & Plastic Surgery · 38d
Cleared Jul 12, 2013
REMEL XPECT FLU A&B
K131804 · GNX
Remel, Inc.
Microbiology · 23d
Cleared Jul 11, 2013
MESOTHELIUM DENTAL MEMBRANE
K121310 · NPL
Kensey Nash Corporation
Dental · 436d
Cleared Jul 11, 2013
BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B
K123075 · NGX
Well-Life Healthcare Limited
Physical Medicine · 283d
Cleared Jul 11, 2013
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
K123343 · MLM
Microgenics Corp.
Toxicology · 253d
Cleared Jul 11, 2013
HEARTSINE SAMARITAN PAD 350P
K123881 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 206d
Cleared Jul 11, 2013
QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS
K130225 · OHS
Silverbay, LLC, D/B/A Quasar Bio-Tech
General & Plastic Surgery · 163d
Cleared Jul 11, 2013
CLINICAL ALERT NOTIFICATION
K130339 · MSX
Extension , Inc.
Cardiovascular · 150d
Cleared Jul 11, 2013
STIMEL-03
K130424 · IPF
Stimel, Ltd.
Physical Medicine · 141d
Cleared Jul 11, 2013
NXSTAGE DOSING CALCULATOR
K130460 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 139d
Cleared Jul 11, 2013
ETCH GEL
K131248 · KLE
Dmg America, LLC
Dental · 71d
Cleared Jul 11, 2013
MONTERIS MEDICAL NEUROBLATE SYSTEM
K131278 · GEX
Monteris Medical, Inc.
General & Plastic Surgery · 66d
Cleared Jul 11, 2013
NEXUS HEMORRHOID LIGATOR
K131282 · FHN
Inx Medical
Gastroenterology & Urology · 66d
Cleared Jul 11, 2013
NEXUS ANTERIOR CERVICAL PLATE SYSTEM
K131520 · KWQ
Core-Nexus
Orthopedic · 44d
Cleared Jul 10, 2013
FUSEFORCE IMPLANT SYSTEM
K124045 · JDR
Solana Surgical, LLC
Orthopedic · 191d
Cleared Jul 10, 2013
QDC-PRO, AND NOX-RIP
K124062 · MNR
Nox Medical
Anesthesiology · 191d
Cleared Jul 10, 2013
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA...
K130391 · LOX
Boston Scientific Corp
Cardiovascular · 145d
Cleared Jul 10, 2013
AIGIS RX N MEDIUM
K131007 · FTL
Tyrx, Inc.
General & Plastic Surgery · 90d
Cleared Jul 10, 2013
DLP CORONARY OSTIAL PERFUSION CANNULAE
K131269 · DWF
Medtronic, Inc.
Cardiovascular · 68d