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
160609–160632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 09, 1982
QUANTUM MODELS 253-09, 254-09 254-10
K820853 · DXY
Intermedics, Inc.
Cardiovascular · 14d
Cleared Apr 08, 1982
MARK 500 SYSTEM
K812416
Kallestad Laboratories, Inc.
Obstetrics & Gynecology · 227d
Cleared Apr 08, 1982
GLYCO-GEL TEST KIT
K820279 · LCP
Pierce Chemical Co.
Hematology · 65d
Cleared Apr 08, 1982
CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV
K820298 · DHX
Ventrex Laboratories, Inc.
Immunology · 63d
Cleared Apr 08, 1982
SPIRAL STONE AND RETRIEVAL BASKETS
K820429 · OCZ
American Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 08, 1982
DIATHERMIC SNARES
K820430 · KNS
American Endoscopy, Inc.
Gastroenterology & Urology · 50d