FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128953–128976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1989
INTRASITE CAVITY WOUND DRESSING
K895354 · KOZ
Smith & Nephew United, Inc.
General & Plastic Surgery · 67d
Cleared Nov 06, 1989
ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
K884651 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 364d
Cleared Nov 06, 1989
BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE
K890044 · HRY
Biopro, Inc.
Orthopedic · 305d
Cleared Nov 06, 1989
CCO SYSTEM MODEL SP1467,SP5567,SP6267
K892941 · KRB
Spectramed, Inc.
Cardiovascular · 199d
Cleared Nov 06, 1989
SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
K893744 · LNH
Shimadzu Medical Systems
Radiology · 172d
Cleared Nov 06, 1989
ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.
K893821 · JDI
Kinamed, Inc.
Orthopedic · 167d
Cleared Nov 06, 1989
THERASTIM
K893851 · IPF
Physiodynamics, Inc.
Physical Medicine · 165d
Cleared Nov 06, 1989
TOITU FETAL ACTOCARDIOGRAPH, MT-332
K894036 · HGM
Toitu of America, Inc.
Obstetrics & Gynecology · 153d
Cleared Nov 06, 1989
ULTRANET-S COLLIMATOR
K894142 · IZW
GE Medical Systems
Radiology · 146d
Cleared Nov 06, 1989
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K894514 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 110d
Cleared Nov 06, 1989
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
K895026 · HGL
Hewlett-Packard Co.
Obstetrics & Gynecology · 90d
Cleared Nov 06, 1989
MODEL 410T TELECOMMUNICATION SYSTEM
K895045 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 89d
Cleared Nov 06, 1989
ARROW HANDS-OFF THERMO-PACE
K895268 · DQO
Arrow Intl., Inc.
Cardiovascular · 75d
Cleared Nov 06, 1989
ULTIMA XS MICROCURRENT TENS
K895295 · GZJ
American Imex
Neurology · 73d
Cleared Nov 06, 1989
AVL MODEL 912 CO-OXYLITE
K895466 · GLY
Avl Scientific Corp.
Hematology · 56d
Cleared Nov 06, 1989
PATIENT POSITIONING ACCESSORIES
K895500 · IYE
Perkins Mfg. Co.
Radiology · 55d
Cleared Nov 06, 1989
PEMACO 3000 INTRAORAL DENTAL WAX
K895561 · EGD
Pemaco, Inc.
Dental · 61d
Cleared Nov 06, 1989
PEMACO 2000 INTRAORAL DENTAL WAX
K895562 · EGD
Pemaco, Inc.
Dental · 61d
Cleared Nov 06, 1989
PEMACO BITE WAX SHEETS
K895563 · EGD
Pemaco, Inc.
Dental · 61d
Cleared Nov 06, 1989
PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD
K895564 · EGD
Pemaco, Inc.
Dental · 61d
Cleared Nov 06, 1989
PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT
K895566 · EGD
Pemaco, Inc.
Dental · 61d
Cleared Nov 06, 1989
STIMTRAC II CATALOG NUMBER 78-8500
K895671 · IPF
Stimtech Products
Physical Medicine · 47d
Cleared Nov 06, 1989
BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES
K895725 · FCG
Interson Corp.
Gastroenterology & Urology · 42d
Cleared Nov 06, 1989
X-RAY EQUIPMENT (VARIOUS TYPES)
K895730 · JAA
Continental X-Ray Corp.
Radiology · 45d