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
118729–118752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1991
ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF
K912398 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 207d
Cleared Dec 17, 1991
MEDE-FLO I.V. EXTENSION SET
K912856 · FPA
Medevice, Inc.
General Hospital · 172d
Cleared Dec 17, 1991
PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE
K912902 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 168d
Cleared Dec 17, 1991
INFLUENZA MAB TEST/INFLUENZA A TEST
K913351 · GNW
Gull Laboratories, Inc.
Microbiology · 144d
Cleared Dec 17, 1991
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
K913384 · JPD
Helena Laboratories
Hematology · 141d
Cleared Dec 17, 1991
SOPHY NXT
K913641 · KPS
Sopha Medical Systems, Inc.
Radiology · 126d
Cleared Dec 17, 1991
SPECIALTY CONTROLS INTERFACE
K913645 · ITI
Everest & Jennings, Inc.
Physical Medicine · 123d
Cleared Dec 17, 1991
PALCO LABS LOADMATIC
K913694 · FMF
Palco Laboratories, Inc.
General Hospital · 120d
Cleared Dec 17, 1991
SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM
K913746 · ITX
Peripheral Systems Group
Radiology · 118d
Cleared Dec 17, 1991
MICROSURGE LASER FIBER WITH SMA CONNECTOR
K914175 · GEX
Microsurge, Inc.
General & Plastic Surgery · 90d
Cleared Dec 17, 1991
MENS 2000-D
K914441 · GZJ
Monad Corp.
Neurology · 78d
Cleared Dec 17, 1991
ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED
K914726 · GEX
Ion Laser Technology
General & Plastic Surgery · 57d
Cleared Dec 17, 1991
ASL MODEL 101
K914738 · ITI
Adaptive Switch Laboratories, Inc.
Physical Medicine · 57d
Cleared Dec 17, 1991
LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY
K914835 · CEC
London Diagnostics, Inc.
Chemistry · 53d
Cleared Dec 17, 1991
PRECISE TM HCG
K915197 · JHI
Becton Dickinson Advanced Diagnostics
Chemistry · 28d
Cleared Dec 17, 1991
LASER FIBEROPTIC DELIVERY SYSTEM
K915352 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 21d
Cleared Dec 17, 1991
MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE
K915393 · GDC
Mdt Corp., Inc.
General & Plastic Surgery · 18d
Cleared Dec 16, 1991
TANDEM SCANNING MICROSCOPE
K912514 · HJO
Tandem Scanning Corp.
Ophthalmic · 193d
Cleared Dec 16, 1991
ZOLL D-900 DEFIBRILLATOR
K913484 · LDD
Zmi Corp.
Cardiovascular · 132d
Cleared Dec 16, 1991
APR II HIP SYSTEM
K913634 · JDI
Intermedics Orthopedics
Orthopedic · 123d
Cleared Dec 16, 1991
TROCAR CATHETER
K913678 · KGY
Medovations, Inc.
General & Plastic Surgery · 119d
Cleared Dec 16, 1991
ROCATEC(R) -PLUS
K913857 · EJH
Espe GmbH (Us)
Dental · 111d
Cleared Dec 16, 1991
HELIOLUX
K913980 · EBZ
Ivoclar North America, Inc.
Dental · 101d
Cleared Dec 16, 1991
MIDAS BRACKET
K914003 · EJF
Gold'N Braces, Inc.
Dental · 101d