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
134521–134544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1988
CANON IOL ESTIMATOR KU-1
K881889 · IYO
Canon USA, Inc.
Radiology · 133d
Cleared Sep 15, 1988
BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
K882556 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 86d
Cleared Sep 15, 1988
EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM
K882605 · HIB
Buckman Co., Inc.
Obstetrics & Gynecology · 83d
Cleared Sep 15, 1988
ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
K882721 · ESD
Hear-O Inc. C/O L.P. Leale & Assoc.
Ear, Nose, Throat · 76d
Cleared Sep 15, 1988
VITRABOND LIGHT CURE GLASS IONOMER LINER
K882821 · EKJ
3M Company
Dental · 69d
Cleared Sep 15, 1988
SITE MACROBORE PHACO NEEDLE
K883099 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 55d
Cleared Sep 15, 1988
MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
K883199 · HQC
Chiron Vision Corp.
Ophthalmic · 49d
Cleared Sep 15, 1988
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
K883213 · HQF
Nidek, Inc.
Ophthalmic · 48d
Cleared Sep 15, 1988
KOMET SURGICAL BUR
K883255 · GFF
Komet Medical, Div. of Brasseler USA...
General & Plastic Surgery · 44d
Cleared Sep 15, 1988
COUNT-A-DOSE
K883311 · FMF
Pavel Jordan & Associates, Inc.
General Hospital · 41d
Cleared Sep 15, 1988
HERAEUS C SPECIAL
K883507 · EJS
Degussa Dental, Inc.
Dental · 29d
Cleared Sep 15, 1988
DEGUPAL 4
K883510 · EJS
Degussa Dental, Inc.
Dental · 29d
Cleared Sep 15, 1988
OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.
K883613 · GDC
Stierlen-Maquet AG
General & Plastic Surgery · 24d
Cleared Sep 15, 1988
CYTOGUARD(R)
K883614 · FMF
Survival Technology, Inc.
General Hospital · 22d
Cleared Sep 15, 1988
SKID RESISTANT, LONG LASTING SHOE COVERS
K883657 · FXP
James River Corp.
General Hospital · 20d
Cleared Sep 15, 1988
SUNGLASSES, IMPORTED
K883771 · HQY
Norcon, Inc.
Ophthalmic · 9d
Cleared Sep 14, 1988
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
K870722 · FJK
National Medical Care, Medical...
Gastroenterology & Urology · 587d
Cleared Sep 14, 1988
MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K881478 · KNQ
Keymed (Medical & Industrial...
Gastroenterology & Urology · 161d
Cleared Sep 14, 1988
BREAST LESION LOCALIZATION NEEDLE
K881697 · IZH
Bd Becton Dickinson Vacutainer...
Radiology · 148d
Cleared Sep 14, 1988
OMEGA NV(TM) BALLOON DILATATION CATHETER
K882052 · LIT
Cook, Inc.
Cardiovascular · 121d
Cleared Sep 14, 1988
SHIMADZU LATERAL C-ARM MH-31
K882311 · JAA
Shimadzu Precision Instruments, Inc.
Radiology · 103d
Cleared Sep 14, 1988
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
K882394 · CAZ
Medtronic Vascular
Anesthesiology · 96d
Cleared Sep 14, 1988
COULTER CLONE B1 MONOCLONAL ANTIBODY
K882557 · GKZ
Coulter Immunology
Hematology · 85d
Cleared Sep 14, 1988
DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM
K883072 · IZI
Siemens Gammasonics, Inc.
Radiology · 56d