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
151105–151128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1984
THE CLINICIAN
K842574 · GEI
Solidstate Systems Corp.
General & Plastic Surgery · 84d
Cleared Sep 25, 1984
T.O.D. PLATE SYSTEM
K842681 · KTT
Kirschner Medical Corp.
Orthopedic · 77d
Cleared Sep 25, 1984
T.O.D. PLATE SYS STERILE
K842695 · KTT
Kirschner Medical Corp.
Orthopedic · 76d
Cleared Sep 25, 1984
EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
K842714 · GWQ
Nihon Kohden America, Inc.
Neurology · 75d
Cleared Sep 25, 1984
CRYSTAL MEDICAL MILK COLLECTION KIT
K842766 · HGX
Crystal Medical Products, Inc.
Obstetrics & Gynecology · 71d
Cleared Sep 25, 1984
MEDICAL DIAG. ULTRASOUND INSTR. 77065
K842897 · IYO
Hewlett-Packard Co.
Radiology · 64d
Cleared Sep 25, 1984
LORRAINE DSL LABOR & DELIVERY BED
K842962 · KNC
Pulley-Kellam Co., Inc.
Obstetrics & Gynecology · 60d
Cleared Sep 25, 1984
PERRY DERMAGUARD SURGICAL GLOVES
K843125 · KGO
Perry, Div.
General Hospital · 48d
Cleared Sep 25, 1984
BRIMFIELD CANNULATED GRASPING HOOKS
K843136 · GDG
Brimfield Scientific Instruments
General & Plastic Surgery · 47d
Cleared Sep 25, 1984
AUTO SUTURE SURGICLIP DISPOS. CLIP APPL
K843312
United States Surgical, A Division of...
General & Plastic Surgery · 32d
Cleared Sep 25, 1984
EMIT 700 CANNABINOID ASSAY
K843421 · LDJ
Syva Co.
Toxicology · 25d
Cleared Sep 24, 1984
ELECTRODE PACEMAKER, PERM & TEMP
K840668 · DTB
Vitatron Medical BV
Cardiovascular · 237d
Cleared Sep 24, 1984
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K842364 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 98d
Cleared Sep 24, 1984
VENI-SHIELD
K842999 · KMK
U.S. Mfg. & Management, Inc.
General Hospital · 56d
Cleared Sep 24, 1984
LIFELINE TLE 476-04
K843393 · DTB
Intermedics, Inc.
Cardiovascular · 26d
Cleared Sep 24, 1984
LIFELINE TLE 484-02
K843394 · DTB
Intermedics, Inc.
Cardiovascular · 26d
Cleared Sep 24, 1984
PHARMA-PLAST SMOOTH BORE CONNECTORS
K843476 · GAZ
Zimmar Consulting , Ltd.
General Hospital · 18d
Cleared Sep 21, 1984
12SSL-SC
K842308 · LOS
Marquette Electronics, Inc.
Cardiovascular · 101d
Cleared Sep 21, 1984
WRINKLE CHAPEAU BLACKY
K842502 · HIS
Circle Rubber Corp.
Obstetrics & Gynecology · 87d
Cleared Sep 21, 1984
STANBIO QUICK-TELL MONOCLONAL INDIRECT
K842544 · JHJ
Stanbio Laboratory
Chemistry · 81d
Cleared Sep 21, 1984
ACE/FISHER EXTERNAL FIXATOR
K842768 · KTT
Buckman Co., Inc.
Orthopedic · 67d
Cleared Sep 21, 1984
DRABKIN REAGENT
K842931 · KAG
E K Ind., Inc.
Hematology · 58d
Cleared Sep 21, 1984
AXCAN UTERINE SUCCION INJECTOR
K842943 · HIG
Axcan Scientific Corp.
Obstetrics & Gynecology · 58d
Cleared Sep 21, 1984
ANGIO SYS STERILE FIELD COVER
K843257
Angiosystems, Inc.
General & Plastic Surgery · 32d