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
156121–156144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1983
ULTRA PULSATOR MF
K831473 · IPF
Medelco , Ltd.
Physical Medicine · 81d
Cleared Jul 26, 1983
MINI PULSATOR
K831474
Medelco , Ltd.
Physical Medicine · 81d
Cleared Jul 26, 1983
HEATING BLOCK MICROELISA SYSTEM
K831642 · LIB
Organon Teknika Corp.
Chemistry · 64d
Cleared Jul 26, 1983
STRIPREADER MICROELISA SYSTEM
K831643 · LIB
Organon Teknika Corp.
Chemistry · 64d
Cleared Jul 26, 1983
TEMP. BIPOLAR EPICARDIAL LEAD
K831645 · LDF
Cordic Corp.
Cardiovascular · 64d
Cleared Jul 26, 1983
MICROELISA COMP
K831658 · LIB
Organon Teknika Corp.
Chemistry · 64d
Cleared Jul 26, 1983
AMOXAPINE 8-HYDRO-XYAMOXAPINE
K831734 · DIF
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 26, 1983
MAPROTILINE
K831735 · LAS
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 26, 1983
CAFFINE TOXICOLOGY CONTROL
K831738 · LAS
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 26, 1983
FLURAZEPAM TOXICOLOGY CONTROL
K831741 · DIF
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 26, 1983
PM-3
K831750 · DXS
Delta Medical Industries
Cardiovascular · 55d
Cleared Jul 26, 1983
IMPLANTABLE CARDIAC PACING LEADS
K831767 · DTB
Oscor, Inc.
Cardiovascular · 55d
Cleared Jul 26, 1983
EGG YOLK AGAR
K831827 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 49d
Cleared Jul 26, 1983
UNIVERSAL LEVEL SENSOR
K831879 · DTW
3M Health Care, Sarns
Cardiovascular · 43d
Cleared Jul 26, 1983
MEDTRONIC MODELS 4012 & 4512
K832099 · DTB
Medtronic Vascular
Cardiovascular · 27d
Cleared Jul 26, 1983
HEARING AID G3H & G3T
K832129 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jul 26, 1983
CIRCUT 1
K832147
Brimfield Scientific Instruments
General & Plastic Surgery · 26d
Cleared Jul 26, 1983
DELTA CONDUCTIVE ADHESIVE ELECTROSURG-
K832157 · GEI
Delta Medical Electronics, Inc.
General & Plastic Surgery · 21d
Cleared Jul 26, 1983
SURGICAL FACE MASK-DISPOSABLE
K832194 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 18d
Cleared Jul 26, 1983
GAUZE CONVERSION CLASS II STERILE
K832213 · EFQ
Winn Hirsch & Assoc.
General & Plastic Surgery · 14d
Cleared Jul 26, 1983
GAUZE CONVERSION CLASS I-NON-STERILE
K832214 · EFQ
Winn Hirsch & Assoc.
General & Plastic Surgery · 14d
Cleared Jul 26, 1983
I.V. BAG ADDISEAL
K832247 · KPE
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 15d
Cleared Jul 26, 1983
BAXA ADDISEAL
K832254 · KPE
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 15d
Cleared Jul 22, 1983
TRIGLYCERIDES REAGENT SET
K831858 · CDT
Stanbio Laboratory
Chemistry · 42d