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
150169–150192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1984
UROPAPER EIKEN 5
K843756 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN AG
K843757 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN GK
K843758 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN HAG
K843759 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN G
K843760 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
K843978 · LLL
Behring Diagnostics, Inc.
Immunology · 68d
Cleared Dec 18, 1984
PROVIDER PA 3000 INFUSION SYSTEM
K844078 · FRN
Pancretec, Inc.
General Hospital · 60d
Cleared Dec 18, 1984
MICRO-BETA U100 SYRINGE
K844796 · FMF
Orange Medical Instruments, Inc.
General Hospital · 7d
Cleared Dec 17, 1984
MONOJECT MENGHINI SOFT TISSUE BIOPSY
K843264 · FMI
Sherwood Medical Co.
General Hospital · 119d
Cleared Dec 17, 1984
ND3100 VIDEO IMAGER
K843349 · LMB
Nuclear Data, Inc.
Radiology · 112d
Cleared Dec 17, 1984
PACE *AID MODEL 52
K843547 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 98d
Cleared Dec 17, 1984
QCA HEMOGLOBIN KIT
K843695 · KRZ
Bd Becton Dickinson Vacutainer...
Hematology · 89d
Cleared Dec 17, 1984
CLOSED URINARY DRAINAGE UNIT
K843698 · KNX
Pathfinder Intl. Corp.
Gastroenterology & Urology · 88d
Cleared Dec 17, 1984
NUCLEAR 700 MEDICINE MECHANICAL POSIT-
K843716 · IYX
Technicare Corp.
Radiology · 84d
Cleared Dec 17, 1984
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
K843805 · JPK
Coulter Electronics, Inc.
Hematology · 81d
Cleared Dec 17, 1984
COROMETRICS FETAL MONITOR 142
K843918 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 73d
Cleared Dec 17, 1984
PRESTILIX 1690
K843926 · IXR
Cgr Medical Corp.
Radiology · 51d
Cleared Dec 17, 1984
CT 9000
K843927 · JAK
General Electric Co.
Radiology · 73d
Cleared Dec 17, 1984
COUNTERBALANCED VERTICAL CASSETTE HOLDER
K843928 · IYB
Poersch Metal Mfg. Co.
Radiology · 73d
Cleared Dec 17, 1984
CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE
K844015 · GWS
Cns, Inc.
Neurology · 66d
Cleared Dec 17, 1984
CLAMP, TUBING, LINE
K844121 · FKK
Dyn-A-Med Products
Gastroenterology & Urology · 55d
Cleared Dec 17, 1984
VENTIBOX
K844160 · KPY
Syncor Intl. Corp.
Radiology · 54d
Cleared Dec 17, 1984
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
K844280 · KNX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 42d
Cleared Dec 17, 1984
SCRUB MATE DRY STERILE SCRUB BRUSH
K844411 · GEC
American Sterilizer Co.
General & Plastic Surgery · 33d