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
151129–151152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1984
ANGIO SYS BRACHIAL ANGIO DRAPE
K843258
Angiosystems, Inc.
General & Plastic Surgery · 32d
Cleared Sep 21, 1984
ANGIO SYS FLUOROSCOPE DRAPE
K843259
Angiosystems, Inc.
General & Plastic Surgery · 32d
Cleared Sep 21, 1984
ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE
K843260 · KKX
Angiosystems, Inc.
General Hospital · 32d
Cleared Sep 21, 1984
MINICAPS
K843361 · GIO
Medical Technomics, Ltd.
Hematology · 24d
Cleared Sep 21, 1984
RINGCAPS
K843362 · GIO
Medical Technomics, Ltd.
Hematology · 24d
Cleared Sep 21, 1984
PHARMA-PLAST PETRI DISH
K843483 · LIB
Zimmar Consulting , Ltd.
Microbiology · 15d
Cleared Sep 21, 1984
PRECISION DISPENSER
K843606 · JQW
Medical Technomics, Ltd.
Chemistry · 8d
Cleared Sep 21, 1984
LABOPETTOR
K843607 · JQW
Medical Technomics, Ltd.
Chemistry · 8d
Cleared Sep 20, 1984
SELF-ALIGNING ACETABULAR COMPONENT
K831792 · JDL
Endomedics, Inc.
Orthopedic · 475d
Cleared Sep 20, 1984
AUSTIN ENDOLYMPH DISPERSMENT SHUNT
K834094 · ESZ
Treace Medical, Inc.
Ear, Nose, Throat · 297d
Cleared Sep 20, 1984
SERVOMED MEDIVISION SCOPE SMV-235
K840209 · DXJ
Litton Medical Electronics
Cardiovascular · 245d
Cleared Sep 20, 1984
MEDILASER-S MEL-444-S
K840739 · GEX
Mochida Pharmaceutical Co., Ltd.
General & Plastic Surgery · 212d
Cleared Sep 20, 1984
SERVOMED OXCARDIORE SPIROGRAPH 324/111
K840832 · DRT
Litton Medical Electronics
Cardiovascular · 209d
Cleared Sep 20, 1984
FRONT RADIUS CUTTER
K841620 · HTX
Plastafil, Inc.
Orthopedic · 154d
Cleared Sep 20, 1984
BACK RADIUS CUTTER
K841621 · HTX
Plastafil, Inc.
Orthopedic · 154d
Cleared Sep 20, 1984
UNILET LANCET
K842517 · FML
Ulster Scientific, Inc.
General Hospital · 72d
Cleared Sep 20, 1984
AMIZYME-ANA TEST KIT
K842532 · LJM
Amico Lab, Inc.
Immunology · 84d
Cleared Sep 20, 1984
AMIZYME-ANDNA TEST KIT
K842533 · LJM
Amico Lab, Inc.
Immunology · 84d
Cleared Sep 20, 1984
CUSTOM NEURO TRAY
K842625
Deroyal Industries, Inc.
Neurology · 76d
Cleared Sep 20, 1984
GENERAL SURGERY TRAY
K842648 · LRO
Deroyal Industries, Inc.
General & Plastic Surgery · 38d
Cleared Sep 20, 1984
NU-THOR THORACOSTOMY KIT
K842666 · KGZ
Intl. Medical Devices , Ltd.
General & Plastic Surgery · 72d
Cleared Sep 20, 1984
SANG-A PETROLATUM GAUZE USP STERILE
K843035 · FRO
Tech-Cons Ltd., Intl.
General & Plastic Surgery · 49d
Cleared Sep 20, 1984
SENTRA
K843060 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Sep 20, 1984
IVAC C80014 Y SOLUTION ADMIN. SET
K843185 · FPA
Y
General Hospital · 38d