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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76897–76920 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2002
DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
K013513 · HRX
Pain Concepts, Inc.
Orthopedic · 87d
Cleared Jan 17, 2002
SIMPLE
K013519 · KLE
Bisco, Inc.
Dental · 86d
Cleared Jan 17, 2002
ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
K013539 · DXN
Rossmax International , Ltd.
Cardiovascular · 85d
Cleared Jan 17, 2002
POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN...
K013554 · LYY
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 84d
Cleared Jan 17, 2002
MAGICFIL
K013571 · EBF
Dmg USA, Inc.
Dental · 80d
Cleared Jan 17, 2002
ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE...
K013583 · DXN
Rossmax International , Ltd.
Cardiovascular · 79d
Cleared Jan 17, 2002
PERMACOL
K013625 · FTM
Tissue Science Laboratories, Plc
General & Plastic Surgery · 73d
Cleared Jan 17, 2002
GLOBAL HEALTHCARE VAGINAL SPECULUM
K013835 · HIB
Dynascend Consulting Int'L, LLC
Obstetrics & Gynecology · 59d
Cleared Jan 17, 2002
3DFIS, MODEL IES-FL-101
K013841 · LLZ
3Dsharp, Inc.
Radiology · 58d
Cleared Jan 17, 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 57d
Cleared Jan 17, 2002
SIMPLICITY STARPLUS SOFT INFUSION SET
K014061 · FPA
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Jan 17, 2002
SIMPLICITY EASY ACCESS INFUSION SET
K014062 · FPA
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Jan 17, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K014136 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 31d
Cleared Jan 17, 2002
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM,...
K014145 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jan 17, 2002
SELF-DRILLING RADIOGRAPHIC MARKER
K014148 · NEU
Walter Lorenz Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Jan 17, 2002
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
K014157 · MKJ
Philips Medical Systems
Cardiovascular · 29d
Cleared Jan 17, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K014194 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Jan 17, 2002
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · DQY
C.R. Bard, Inc.
Cardiovascular · 27d
Cleared Jan 17, 2002
SIEMENS INFINITY GATEWAY SUITE
K014213 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 27d
Cleared Jan 17, 2002
BREATHTEK - UBIT UBT FOR H. PYLORI
K014225 · MSQ
Meretek Diagnostics, Inc.
Microbiology · 22d
Cleared Jan 17, 2002
MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND:...
K014234 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 22d
Cleared Jan 16, 2002
LUMEND PERCUTANEOUS CATHETER
K011562 · DQY
Lumend, Inc.
Cardiovascular · 240d
Cleared Jan 16, 2002
OSTEOMED BIORESORBABLE FIXATION SYSTEM
K012486 · DZL
Osteomed Corp.
Dental · 167d
Cleared Jan 16, 2002
KONICA LASER IMAGER, DRYPRO MODEL 751/752
K013052 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 127d