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
143449–143472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1986
STACLOT PROTEIN C TEST KIT
K861079 · GGP
American Bioproducts Co.
Hematology · 90d
Cleared Jun 19, 1986
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY
K861372 · GEI
Snowden-Pencer
General & Plastic Surgery · 69d
Cleared Jun 19, 1986
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
K861377 · JXG
Cordis Corp.
Neurology · 66d
Cleared Jun 19, 1986
ELECTROSURGICAL BLADE ELECTRODE (SOLID TYPE)
K861495 · GEI
National Wire & Stamping, Inc.
General & Plastic Surgery · 58d
Cleared Jun 19, 1986
PORT-A-TRAC
K861554 · JFB
Port-A-Trac Co.
Physical Medicine · 55d
Cleared Jun 19, 1986
TERUMO SENSIBEAD EIA TSH KIT
K861573 · JLW
Terumo Medical Corp.
Chemistry · 52d
Cleared Jun 19, 1986
ACUSON S228, S519 & L558 TRANSDUCERS
K861577 · HGL
Acuson Computed Sonography
Obstetrics & Gynecology · 52d
Cleared Jun 19, 1986
ELECTROSURGICAL NEEDLE ELECTRODE (SOLID TYPE)
K861594 · GEI
National Wire & Stamping, Inc.
General & Plastic Surgery · 51d
Cleared Jun 19, 1986
BALL ELECTRODES
K861595 · GEI
National Wire & Stamping, Inc.
General & Plastic Surgery · 51d
Cleared Jun 19, 1986
WISE IRIDOTOMY-SPINCTEROTOMY LENS
K861648 · HJK
Ocular Instruments, Inc.
Ophthalmic · 50d
Cleared Jun 19, 1986
MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR
K861707 · CBK
Siemens Elema AB
Anesthesiology · 45d
Cleared Jun 19, 1986
HIGH EFFICIENCY HEMODIALYSIS SYSTEM
K861776 · KDI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 42d
Cleared Jun 19, 1986
MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER
K861951 · DYB
Teleflex, Inc.
Cardiovascular · 30d
Cleared Jun 19, 1986
MODEL RS-3 RADIOGRAPHIC STAND
K861995 · IYB
Medicor USA , Ltd.
Radiology · 27d
Cleared Jun 19, 1986
IMMPULSE FERRITIN ASSAY REAGENT
K862014 · DBF
Sclavo, Inc.
Chemistry · 22d
Cleared Jun 19, 1986
LIC-ORTHION MULTI-THERAPY TREATMENT TABLE
K862022 · JFB
Lic-Orthion
Physical Medicine · 22d
Cleared Jun 19, 1986
SWAN-NECK PERITONEAL DIALYSIS CATHETERS
K862046 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 21d
Cleared Jun 19, 1986
SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM
K862048 · DQX
Murex Corp.
Chemistry · 21d
Cleared Jun 19, 1986
ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE
K862063 · HQC
Entravision, Inc.
Ophthalmic · 20d
Cleared Jun 19, 1986
ENTRAVISION EP-500 I/A ECCO PACK
K862064 · HQC
Entravision, Inc.
Ophthalmic · 20d
Cleared Jun 19, 1986
LENS-EZE
K862094 · HJK
Insight International, Inc.
Ophthalmic · 17d
Cleared Jun 19, 1986
NO. 100352 GALVANIC OXYGEN SENSOR
K862113 · CCL
Vascular Technology Incorporated
Anesthesiology · 16d
Cleared Jun 19, 1986
STERILE LAPAROTOMY GAUZE SPONGE
K862126 · EFQ
Anago, Inc.
General & Plastic Surgery · 15d
Cleared Jun 19, 1986
HCI MECONIUM ASPIRATOR
K862132 · BSY
Hospital Concepts, Inc.
Anesthesiology · 15d