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
140761–140784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1987
SPARK-KIT(TM)
K864509
Lyphomed, Inc.
General Hospital · 96d
Cleared Feb 18, 1987
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
K864530 · CGA
Miles Laboratories, Inc.
Chemistry · 93d
Cleared Feb 18, 1987
SIMULTRAC FREE T4[57CO]/TSH MAB[125I]
K864838 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 71d
Cleared Feb 18, 1987
JMS HALO APPLICATION TRAY
K864969 · KDD
Jerome Medical
General & Plastic Surgery · 58d
Cleared Feb 18, 1987
SERA-TEK MICROSOMAL ANTIBODY TEST
K865053 · JZO
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Feb 18, 1987
NEW SECOND FRENCH SIZE MAHURKAR CATHETER
K865096 · LFK
Quinton, Inc.
Gastroenterology & Urology · 50d
Cleared Feb 18, 1987
REFLOTRON(R) AST (GOT)
K870246 · CIT
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Feb 18, 1987
MONITORX LASERX THEOPHYLLINE REAGENT SET
K870277 · LGS
American Monitor Corp.
Toxicology · 22d
Cleared Feb 17, 1987
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724 · ELL
Dentsply Intl.
Dental · 77d
Cleared Feb 17, 1987
DOLPHIN UMBILICAL CORD CLAMP
K870446 · HFW
Andermac, Inc.
Obstetrics & Gynecology · 14d
Cleared Feb 13, 1987
QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM
K860581 · IYO
Quantum Medical Systems, Inc.
Radiology · 360d
Cleared Feb 13, 1987
ACUSON S519B TRANSDUCER
K863236
Acuson Computed Sonography
Gastroenterology & Urology · 176d
Cleared Feb 13, 1987
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
K863868 · DFF
Cooper Biomedical, Inc.
Immunology · 133d
Cleared Feb 13, 1987
UTISCREEN(R) BACTERIAL ATP TEST
K864202 · JXA
Los Alamos Diagnostics
Microbiology · 109d
Cleared Feb 13, 1987
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO
K864512 · DAD
Cooper Biomedical, Inc.
Immunology · 92d
Cleared Feb 13, 1987
PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)
K864519 · LLZ
Parexel Intl. Corp.
Radiology · 88d
Cleared Feb 13, 1987
VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER
K864621 · EHZ
Seldoren , Ltd.
Dental · 81d
Cleared Feb 13, 1987
MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH
K864705 · DYB
Quinton, Inc.
Cardiovascular · 73d
Cleared Feb 13, 1987
WAKO (TM) AUTOKIT GOT TEST
K864813 · CIT
Wako Chemicals USA, Inc.
Chemistry · 66d
Cleared Feb 13, 1987
INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM
K864861 · EGM
Instrumentations Unltd.
Dental · 64d
Cleared Feb 13, 1987
ELECTRA AUTOMATIC SAMPLER
K864875 · JQW
Medical Laboratory Automation...
Chemistry · 63d
Cleared Feb 13, 1987
DU PONT LIQUID MULTI-ANALYTE CALIBRATOR
K864909 · JIX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 60d
Cleared Feb 13, 1987
AZTREONAM 30 MCG. SENSI-DISC
K865034 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 52d
Cleared Feb 13, 1987
ASSERA-PLATE PROTEIN S KIT
K870042
American Bioproducts Co.
Hematology · 39d