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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
108505–108528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1994
RNP EIA TEST KIT
K935415 · LJM
David A. Fuccillo, Ph.D.
Immunology · 174d
Cleared May 02, 1994
RO EIA TEST KIT
K935416 · LJM
David A. Fuccillo, Ph.D.
Immunology · 174d
Cleared May 02, 1994
CIRCUMCISION TRAY
K935697 · HFX
Cush Medical Products
Obstetrics & Gynecology · 153d
Cleared May 02, 1994
MURDOCH INTRAOPERATIVE LAPAROSCOPIC LENS CLEANER
K935754 · GCJ
Cook Urological, Inc.
General & Plastic Surgery · 157d
Cleared May 02, 1994
CIR LATEX GLOVES (CIR GOLD SEAL)
K935980 · LYY
Crocker Industrial Resources Sdn. Bhd.
General Hospital · 140d
Cleared May 02, 1994
SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER
K936023 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 138d
Cleared May 02, 1994
GABRIEL URETERAL ILLUMINATOR SYSTEM
K940019 · FCS
Gabriel Medical, Inc.
Gastroenterology & Urology · 119d
Cleared May 02, 1994
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER
K940058 · GIM
Sherwood Medical Co.
Chemistry · 117d
Cleared May 02, 1994
HY BOND, GLASIONOMER CX
K940122 · EMA
Shofu Dental Corp.
Dental · 112d
Cleared May 02, 1994
PERI-STRIPS
K940205 · FTM
Bio-Vascular, Inc.
General & Plastic Surgery · 108d
Cleared May 02, 1994
VERIDENT PLUS, OPTIFORM
K940244 · ELM
Lactona Corp.
Dental · 103d
Cleared May 02, 1994
HISTONE EIA TEST KIT
K940253 · LJM
David A. Fuccillo, Ph.D.
Immunology · 103d
Cleared May 02, 1994
ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN...
K940299 · GEI
Debusk Technology Corp.
General & Plastic Surgery · 101d
Cleared May 02, 1994
ISOLYER (4X4, 12 PLY)
K940754 · EFQ
Thantex Specialties, Inc.
General & Plastic Surgery · 73d
Cleared May 02, 1994
ISOLYER (4X4, 8PLY)
K940755 · NAB
Isolyer Co.
General & Plastic Surgery · 73d
Cleared May 02, 1994
ISOLYSER (X-RAY DETECTABLE)
K940756 · GDY
Thantex Specialties, Inc.
General & Plastic Surgery · 73d
Cleared May 02, 1994
ISOLYSER (4X18) X-RAY DETECTABLE
K940757 · GDY
Thantex Specialties, Inc.
General & Plastic Surgery · 73d
Cleared May 02, 1994
ISOLYSER (18X18 X-RAY DETECTABLE)
K940762 · GDY
Thantex Specialties, Inc.
General & Plastic Surgery · 73d
Cleared May 02, 1994
ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)
K940763 · GDY
Thantex Specialties, Inc.
General & Plastic Surgery · 73d
Cleared May 02, 1994
MYOMA DRILL 5MM-8383.611
K940844 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 68d
Cleared May 02, 1994
LIQUID AST (SGOT)REAGENT SET
K941132 · CIT
Pointe Scientific, Inc.,
Chemistry · 54d
Cleared May 02, 1994
POLY-MEDICS HEAT PACK
K941245 · IMD
Biomet, Inc.
Physical Medicine · 48d
Cleared May 02, 1994
ROLL A BOUT WALKER
K941301 · IOR
Roll A Bout Corp.
Physical Medicine · 46d
Cleared May 02, 1994
CONQUEST PRELUDE
K941374 · EBF
Jeneric/Pentron, Inc.
Dental · 41d