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
115585–115608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1992
IL TEST AST, PN 35312
K923641 · CIT
Instrumentation Laboratory CO
Chemistry · 97d
Cleared Oct 26, 1992
CHOLESTEROL TEST
K923733 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 91d
Cleared Oct 26, 1992
TIMESH TITANIUM MINI-SOFTPLATE/SCREW
K923802 · JEY
Ti-Mesh, Inc.
Dental · 89d
Cleared Oct 26, 1992
IL TEST PT FIBRINOGEN HS
K923921 · GIS
Instrumentation Laboratory CO
Hematology · 82d
Cleared Oct 26, 1992
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
K924074 · CDD
Baxter Diagnostics, Inc.
Chemistry · 75d
Cleared Oct 26, 1992
REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILITY DISK
K924765 · JTN
Remel Co.
Microbiology · 33d
Cleared Oct 26, 1992
REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK
K924766 · JTN
Remel Co.
Microbiology · 33d
Cleared Oct 23, 1992
RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE
K913893 · KGO
Depuy, Inc.
General Hospital · 420d
Cleared Oct 23, 1992
QWIK-1(TM) IN-LINE IV FLUID WARMER
K914867 · LGZ
Microwave Medical Systems, Inc.
General Hospital · 360d
Cleared Oct 23, 1992
FLEXIBLE SILICONE GELIHORN
K920187 · HHW
Bioteque America, Inc.
Obstetrics & Gynecology · 283d
Cleared Oct 23, 1992
VENTILATOR CIRCUITS
K920885 · CAH
Vital Signs, Inc.
General Hospital · 262d
Cleared Oct 23, 1992
OXICOM-2100
K921519 · DQA
Waters Instruments, Inc.
Anesthesiology · 206d
Cleared Oct 23, 1992
8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS
K921755 · LJS
Davol, Inc.
General Hospital · 193d
Cleared Oct 23, 1992
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K922190 · FMF
Advanced Surgical, Inc.
General Hospital · 165d
Cleared Oct 23, 1992
LUNDEEN SUBTALAR PEG IMPLANT
K922292 · MJW
Sgarlato Laboratories, Inc.
Orthopedic · 161d
Cleared Oct 23, 1992
SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509
K922716 · FXX
Splash Shield, Inc.
General Hospital · 140d
Cleared Oct 23, 1992
AD-TECH SUB DURAL ELECTRODEDS
K923803 · GYC
Ad-Tech Medical Instrument Corp
Neurology · 86d
Cleared Oct 23, 1992
TX-3 SD
K923934 · GZJ
Skylark Device Co., Ltd.
Neurology · 79d
Cleared Oct 23, 1992
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K924451 · FGE
Interventional Therapeutics Corp.
Gastroenterology & Urology · 52d
Cleared Oct 22, 1992
PEDIATRIC VENTILATOR AND PARTNER VOLUME MONITOR
K915488 · CBK
Bird Products Corp.
Anesthesiology · 321d
Cleared Oct 22, 1992
VIROTHERM HUMIDIFIER
K915603 · KFZ
Virotherm Laboratory
Anesthesiology · 311d
Cleared Oct 22, 1992
MITEK BONE ANCHOR, MODIFICATION
K915889 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 307d
Cleared Oct 22, 1992
STERILE DISPOSABLE SURGICAL GOWN W/ TOWEL
K920568 · FYA
Border Opportunity Saver Systems, Inc.
General Hospital · 258d
Cleared Oct 22, 1992
S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD
K921111 · LZO
Joint Medical Products Corp.
Orthopedic · 227d