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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
116689–116712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1992
SPINE LINE
K922366 · LYG
Dambrecine, Inc.
Physical Medicine · 54d
Cleared Jul 13, 1992
OLYMPUS CREATINE KINASE REAGENT
K922459 · CGS
Olympus Corp.
Chemistry · 48d
Cleared Jul 13, 1992
ULTRAGATER WHEELCHAIR LIFT
K922624 · ING
Crow River Industries, Inc.
Physical Medicine · 40d
Cleared Jul 13, 1992
TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR
K922772 · IKK
Biodan Medical Systems, Ltd.
Physical Medicine · 34d
Cleared Jul 13, 1992
TUMBLE FORMS TRISTANDER
K922965 · INW
Tumble Forms
Physical Medicine · 24d
Cleared Jul 13, 1992
745-M (MAGNUM)
K922980 · JFB
Tri W-G, Inc.
Physical Medicine · 21d
Cleared Jul 10, 1992
EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF
K914743 · BTO
Pertrach
Anesthesiology · 273d
Cleared Jul 10, 1992
PREMIER COCCIDIOIDES
K915493 · MIY
Meridian Diagnostics, Inc.
Microbiology · 214d
Cleared Jul 10, 1992
CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION
K915791 · HAW
Coritechs, Inc.
Neurology · 199d
Cleared Jul 10, 1992
MRT-150 QD KNEE COIL
K920096 · LNH
Toshiba America Mri, Inc.
Radiology · 184d
Cleared Jul 10, 1992
MRI OE 1.5 SI
K920543 · LNH
Otsuka Electronics
Radiology · 156d
Cleared Jul 10, 1992
DSL ACTIVE ALDOSTERONE (DSL 8600)
K921205 · CJM
Diagnostic Systems Laboratories, Inc.
Chemistry · 120d
Cleared Jul 10, 1992
VACUTAINER BRAND LUER ADAPTER
K921520 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 101d
Cleared Jul 10, 1992
COLUMNMATE II
K921676 · LCP
Helena Laboratories
Hematology · 93d
Cleared Jul 10, 1992
MP3000 SERIES III VIDEO IMAGER
K921992 · LMC
International Imaging Electronics
Radiology · 79d
Cleared Jul 10, 1992
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3
K922046 · JJY
Bio-Rad
Chemistry · 70d
Cleared Jul 10, 1992
KODAK EKTACHEM 250 ANALYER
K922072 · JJE
Eastman Kodak Company
Chemistry · 67d
Cleared Jul 10, 1992
OLYMPUS CALCIUM REAGENT
K922233 · CIC
Olympus Corp.
Chemistry · 59d
Cleared Jul 10, 1992
ELEGANCE FT4 ELISA
K922284 · CEC
Bioclone Australia Pty , Ltd.
Chemistry · 56d
Cleared Jul 10, 1992
P-LINK
K922313 · KPS
Virtual Imaging
Radiology · 70d
Cleared Jul 10, 1992
ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID
K922392 · ESD
A-1 Hearing Aid Lab
Ear, Nose, Throat · 51d
Cleared Jul 10, 1992
ANGEL WING SETS -- MODIFIED
K922468 · GIM
Mbo Laboratories, Inc.
Chemistry · 58d
Cleared Jul 10, 1992
OLYMPUS UREA NITROGEN (BUN) REAGENT
K922597 · CDQ
Olympus Corp.
Chemistry · 38d
Cleared Jul 10, 1992
CORTISOL CHEMILUMINESCENCE ASSAY
K922676 · CGR
Nichols Institute
Chemistry · 36d