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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
172825–172848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#344)
K771490 · FIE
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#364)
K771491 · FIE
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#351)
K771492 · FIE
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#341)
K771493 · FIE
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (354)
K771494 · FIE
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#361)
K771495 · FIE
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
FLEXIBLE ARTERIAL CANNULAE
K771499 · DWF
3M Health Care, Sarns
Cardiovascular · 11d
Cleared Aug 16, 1977
PRESSUROMETER II
K771500 · DXN
Del Mar Avionics
Cardiovascular · 11d
Cleared Aug 16, 1977
SERVO-PAK MOLEL 0030
K771510 · BXA
Isothermal Systems, Inc.
Anesthesiology · 11d
Cleared Aug 16, 1977
CAPILLARY SAMPLE LINE
K771516 · CCI
Mcgaw Respiratory Therapy
Anesthesiology · 8d
Cleared Aug 16, 1977
INSPIRATORY FORCE ADAPTOR
K771518 · CAI
Vital Flow Products Corp.
Anesthesiology · 8d
Cleared Aug 16, 1977
FORCEPS, STYLE #849
K771522 · EMH
Premier Dental Products Co.
Dental · 8d
Cleared Aug 16, 1977
ACCU. CROWN COLD CURE
K771527 · EBG
Parker Laboratories, Inc.
Dental · 8d
Cleared Aug 16, 1977
CATHETER, CARDIAC PACING, ENDOCARDIAL
K771528 · DTB
American Technology, Inc.
Cardiovascular · 8d
Cleared Aug 16, 1977
PERITONEAL INTRODUCER & SHEATH
K771529 · GYK
Cordis Corp.
Neurology · 8d
Cleared Aug 15, 1977
IONTOPHORESIS SYSTEM MODULE, DM 500
K770717 · EGJ
Sorensen Research
Physical Medicine · 119d
Cleared Aug 10, 1977
GREEN RADIOPAQUE IN SURG. SPONGES
K770924 · GDY
Kendall Research Center
General & Plastic Surgery · 82d
Cleared Aug 10, 1977
ELECTROPHORESIS OVEN THERMOMETER
K771323 · JJN
Corning Medical & Scientific
Chemistry · 23d
Cleared Aug 10, 1977
SPINSEP-TBG
K771341 · CEE
Nuclear Diagnostics, Inc.
Chemistry · 22d
Cleared Aug 10, 1977
LDH-INT TEST
K771343 · CFH
Hycel, Inc.
Chemistry · 21d
Cleared Aug 10, 1977
PLATELET COUNTER & HEMATOCRIT ACCES.
K771353 · GKL
Hycel, Inc.
Hematology · 19d
Cleared Aug 10, 1977
TRANSPORTEO MODULE
K771446 · JQX
Hyland Therapeutic Div., Travenol...
Chemistry · 9d
Cleared Aug 05, 1977
RESPIRATOR, PROTABLE, VOLUME CONTROLLED
K771039 · CBK
Dept. of the Navy
Anesthesiology · 57d
Cleared Aug 04, 1977
AUTO DIFFERENTIAL CELL COUNTER SYSTEM
K770244 · GKZ
Abbott Laboratories
Hematology · 178d