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
105025–105048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1994
VERABOND V
K945712 · EJH
Aalba Dent, Inc.
Dental · 38d
Cleared Dec 29, 1994
VERABOND II
K945713 · EJH
Aalba Dent, Inc.
Dental · 38d
Cleared Dec 29, 1994
VERABOND III
K945714 · EJH
Aalba Dent, Inc.
Dental · 38d
Cleared Dec 29, 1994
MATRX MDM, RA
K945722 · BSZ
Matrx Medical, Inc.
Anesthesiology · 38d
Cleared Dec 29, 1994
OPULENT 76 AND 83
K945723 · EJT
Aalba Dent, Inc.
Dental · 38d
Cleared Dec 29, 1994
TOTAL ETCH GEL
K945769 · EBF
Dentsply Intl.
Dental · 57d
Cleared Dec 29, 1994
R&D PART 5518, 5306, 5315 AND 5457
K945867 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 28d
Cleared Dec 29, 1994
QUEST 2 AND 20
K945910 · EJT
Aalba Dent, Inc.
Dental · 27d
Cleared Dec 28, 1994
NEOSCREEN ELISA HYDROXYPROGESTERONE
K940233 · JLX
Pantex
Chemistry · 344d
Cleared Dec 28, 1994
COMPEX 2
K940301 · IPF
Biodex Medical Systems, Inc.
Physical Medicine · 338d
Cleared Dec 28, 1994
AQUALITE FSH
K943437 · CGJ
Sealite Sciences, Inc.
Chemistry · 163d
Cleared Dec 28, 1994
STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES
K943698 · MKJ
Zoll Medical Corp
Cardiovascular · 152d
Cleared Dec 28, 1994
ACE(TM) CEDIA(R) PHENYTOIN ASSAY
K944085 · DIP
Schiapparelli Biosystems, Inc.
Chemistry · 128d
Cleared Dec 28, 1994
DYNAMO
K944277 · INI
Pride Health Care, Inc.
Physical Medicine · 120d
Cleared Dec 28, 1994
ORTHOMET RESURFACING FEMORAL COMPONENT
K944752 · KXA
Orthomet, Inc.
Orthopedic · 93d
Cleared Dec 28, 1994
PHENOBARBITAL FLEX REAGENT CARTRIDGE
K944932 · DLZ
Dupont Medical Products
Toxicology · 83d
Cleared Dec 28, 1994
KITTNER DISSECTOR
K945333 · GDY
Lorrex Health Products
General & Plastic Surgery · 57d
Cleared Dec 28, 1994
CHERRY DISSECTOR
K945335 · GDY
Lorrex Health Products
General & Plastic Surgery · 57d
Cleared Dec 28, 1994
CEDIA DAU BARBITURATE ASSAY
K945344 · DIS
Microgenics Corp.
Toxicology · 57d
Cleared Dec 28, 1994
HORIZON 55 BI-CON
K945365 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 56d
Cleared Dec 28, 1994
ROUND STICK SPONGES, FLAT STICK SPONGES
K945553 · GDY
Lorrex Health Products
General & Plastic Surgery · 48d
Cleared Dec 28, 1994
TRIANGULAR SPONGES
K945606 · GDY
Lorrex Health Products
General & Plastic Surgery · 43d
Cleared Dec 28, 1994
CYLINDRICAL SPONGE
K945866 · GDY
Lorrex Health Products
General & Plastic Surgery · 27d
Cleared Dec 27, 1994
TACTYLON(TM) CONDOM
K911431 · HIS
Tactyl Technologies, Inc.
Obstetrics & Gynecology · 1365d