Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
161449–161472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1982
HEMALET AUTOMATIC LANCET DEVICE
K820625 · FMK
Medprobe Laboratories
General & Plastic Surgery · 32d
Cleared Apr 09, 1982
OPTI-DISC
K820626 · KQM
Video-Medical Devices, Ltd.
General & Plastic Surgery · 32d
Cleared Apr 09, 1982
PEDIATRIC SUCKER
K820638 · KDC
3M Health Care, Sarns
General & Plastic Surgery · 32d
Cleared Apr 09, 1982
OBTURATION SYSTEM KIT
K820639 · EKM
U.S. Shizai Corp.
Dental · 32d
Cleared Apr 09, 1982
RIONET HEARING AID HA-57
K820656 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 31d
Cleared Apr 09, 1982
HS17/HS18 SERIES MONITORS
K820670 · FLL
Medtel Pty. , Ltd.
General Hospital · 29d
Cleared Apr 09, 1982
SELF-CURING HARD DENTURE LINER
K820673 · EBI
Coe Laboratories, Inc.
Dental · 29d
Cleared Apr 09, 1982
DISPOSABLE TUBING SETS
K820680 · KYG
Innovative Surgical Products, Inc.
Ophthalmic · 29d
Cleared Apr 09, 1982
DENTURE ADJUSTMENT KIT
K820685 · EBO
Camdent Laboratories
Dental · 29d
Cleared Apr 09, 1982
C.S.R. WRAPPERS
K820689 · FRG
General Medical Co.
General Hospital · 28d
Cleared Apr 09, 1982
MIDWEST LIGHT WAND
K820693 · EBZ
American Midwest
Dental · 28d
Cleared Apr 09, 1982
CATHETER GUIDE WIRE
K820699 · DQX
Quest Medical, Inc.
Cardiovascular · 25d
Cleared Apr 09, 1982
WATERLESS SEAL & VACUUM REGULATOR
K820706 · KDP
Sorensen Research
General Hospital · 24d
Cleared Apr 09, 1982
MIDDLE EAR ANALYZER (IMPEDANCE AUDIO
K820715 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 25d
Cleared Apr 09, 1982
MICRO CISE DIAMOND SCALPEL
K820730 · GDX
CooperVision, Inc.
General & Plastic Surgery · 23d
Cleared Apr 09, 1982
PERISCOPE VOICE PROSTHESIS
K820737 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 22d
Cleared Apr 09, 1982
LUSTRALLOY
K820738 · EJJ
Hoyt Laboratories
Dental · 22d
Cleared Apr 09, 1982
GLAUKON
K820751 · HKX
Sonometrics Systems, Inc.
Ophthalmic · 21d
Cleared Apr 09, 1982
AMERLEX LH RIA KIT (CODE IM2081)
K820753 · CEP
Amersham Corp.
Chemistry · 21d
Cleared Apr 09, 1982
BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60
K820767 · DTB
Siemens Elema AB
Cardiovascular · 18d
Cleared Apr 09, 1982
IMPLANTABLE, MULTIPROGRAMMABLE
K820774 · DXY
Biotronik Sales, Inc.
Cardiovascular · 17d
Cleared Apr 09, 1982
COAT-A-COUNT AMIKACIN IRA
K820781 · KLQ
Diagnostic Products Corp.
Toxicology · 17d
Cleared Apr 09, 1982
CONCENTRATED CLEANER FOR HARD CONTACTS
K820818 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 16d
Cleared Apr 09, 1982
AUDICRAFT VIP HEARING AID
K820833 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 14d