FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132745–132768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1989
MOLTENO IMPLANT
K890598 · KYF
Iop, Inc.
Ophthalmic · 21d
Cleared Feb 27, 1989
SUTTER HOSPITAL CPM
K890607 · BXB
Sutter Corp.
Physical Medicine · 21d
Cleared Feb 27, 1989
ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES
K890641 · HRS
Acufex Microsurgical, Inc.
Orthopedic · 19d
Cleared Feb 27, 1989
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
K890749 · JPK
R&D Systems, Inc.
Hematology · 14d
Cleared Feb 24, 1989
CRIS ADAPTER
K883986 · FPA
Y
General Hospital · 157d
Cleared Feb 24, 1989
MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD
K884688 · KWP
Synthes (Usa)
Orthopedic · 108d
Cleared Feb 24, 1989
HOLD-FAST DENTURE ADHESIVE
K884999 · KOL
Iodent, Co.
Dental · 85d
Cleared Feb 24, 1989
CLINISTAT HEMOGLOBIN REAGENT TEST
K885227 · KHG
Heraeus Kulzer, Inc.
Hematology · 66d
Cleared Feb 24, 1989
BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT
K885241 · FNJ
King Mfg. Co.
General Hospital · 65d
Cleared Feb 24, 1989
ATS LUGOL'S IODINE SOLUTION
K890020 · JTS
Alpha-Tec Systems, Inc.
Pathology · 51d
Cleared Feb 24, 1989
BIOTRACK APTT REAGENT CARTRIDGE
K890052 · GFO
Biotrack, Inc.
Hematology · 49d
Cleared Feb 24, 1989
MDP DISPOSABLE SYRINGE
K890155 · FMF
Mediplas Marketing
General Hospital · 38d
Cleared Feb 24, 1989
KODAK MIN-R 2 CASSETTE
K890361 · IXA
Eastman Kodak Company
Radiology · 30d
Cleared Feb 24, 1989
CP&S GAVAGE CONSTAINER, DISPOSABLE
K890552 · KNT
Consolidated Products & Services, Inc.
Gastroenterology & Urology · 18d
Cleared Feb 24, 1989
WRIGHT-GLEMSA STAIN
K890673 · IAF
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Feb 24, 1989
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
K890674 · IAF
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Feb 24, 1989
MELANOCYTE GROWTH MEDIUM (MGM)
K890700 · KIT
Clonetics Corp.
Pathology · 14d
Cleared Feb 24, 1989
ENDOTHELIAL GROWTH MEDIUM (EGM)
K890701 · KIT
Clonetics Corp.
Pathology · 14d
Cleared Feb 23, 1989
KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR
K874778 · LMA
Eastman Kodak Company
Radiology · 462d
Cleared Feb 23, 1989
DRENOVAC
K883982 · GCY
Iberhospitex, S.A.
General & Plastic Surgery · 156d
Cleared Feb 23, 1989
CNS-8200A CENTRAL NURSES STATION
K884050 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 150d
Cleared Feb 23, 1989
HIGH RESOLUTION OPTION FOR MAC SERIES ELECTROCARDI
K884087 · LOS
Marquette Electronics, Inc.
Cardiovascular · 149d
Cleared Feb 23, 1989
PATIENT MONITOR MODEL 701
K884096 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 148d
Cleared Feb 23, 1989
THYROXINE MICROASSAY
K884260 · KLI
Diamedix Corp.
Chemistry · 135d