Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Cleared only ×
175,820 results
139561–139584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1987
TEMREX ETCHING GEL
K872569 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 22d
Cleared Jul 21, 1987
FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH
K872627 · CGJ
Serono Diagnostics, Inc.
Chemistry · 15d
Cleared Jul 21, 1987
INNOFLUOR VANCOMYCIN CALIBRATOR SET
K872644 · DLJ
Innotron of Oregon, Inc.
Toxicology · 15d
Cleared Jul 21, 1987
RGB CAMERA SYSTEM
K872661 · FWF
Aspen Laboratories, Inc.
General & Plastic Surgery · 14d
Cleared Jul 21, 1987
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
K872714 · GBI
Roseburg SA
General & Plastic Surgery · 11d
Cleared Jul 21, 1987
QM300 HAPTOGLOBIN ANTIBODY PACK
K872717 · DAD
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 11d
Cleared Jul 21, 1987
VINYL POLYSILOXANE IMPRESSION SYSTEM
K872745 · ELW
Crown Delta Corp.
Dental · 8d
Cleared Jul 21, 1987
VITALLIUM WIRE
K872746 · EJW
Austenal Dental, Inc.
Dental · 8d
Cleared Jul 20, 1987
ENZYGNOST ANTI-CMV IGG TEST
K863488 · GQI
Behring Diagnostics, Inc.
Microbiology · 314d
Cleared Jul 20, 1987
TDXR FETAL LUNG MATURITY
K871593 · JHG
Abbott Laboratories
Chemistry · 87d
Cleared Jul 17, 1987
FLEXIBLE FASCICULATED BONE PLATE
K870041 · JEY
The Deca Co.
Dental · 193d
Cleared Jul 17, 1987
CLEARFIL FII NEW BOND
K871634 · EBF
Kuraray Co.
Dental · 81d
Cleared Jul 17, 1987
CLEARFIL CORE NEW BOND
K871637 · EBF
Kuraray Co.
Dental · 81d
Cleared Jul 16, 1987
MINOS AUTOMATIC CELL COUNTER
K864579 · GKZ
Abx, Inc.
Hematology · 238d
Cleared Jul 16, 1987
GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT
K870176 · LKT
Genetic Systems Corp.
Microbiology · 182d
Cleared Jul 16, 1987
NITROGLYCERINE PUMP SET
K871084 · FRN
Churchill Corp.
General Hospital · 120d
Cleared Jul 16, 1987
MINISTIK MINI PUNCTURE SET CATALOG CODE #57505
K871137 · DQX
Dlp, Inc.
Cardiovascular · 118d
Cleared Jul 16, 1987
DELFLEX RIGID DRAIN CONTAINER
K871155 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 114d
Cleared Jul 16, 1987
KUMAR CERVICAL APPLICATOR
K871213 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 112d
Cleared Jul 16, 1987
HENSCHKE AFTERLOADING APPLICATOR
K871217 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 112d
Cleared Jul 16, 1987
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.
K871220 · HHR
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 118d
Cleared Jul 16, 1987
MURRAY/WELCH TOTAL HIP SYSTEM
K871402 · JDI
Kirschner Medical Corp.
Orthopedic · 99d
Cleared Jul 16, 1987
RESPIRONICS SANDERS BIPAPEASY
K871523 · BYE
Respironics, Inc.
Anesthesiology · 87d
Cleared Jul 16, 1987
ROKONICS 8500
K871576 · BZQ
Rokonics, Inc.
Anesthesiology · 85d