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
147289–147312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1985
RF CARD TEST
K853054 · DHR
Preco, Inc.
Immunology · 13d
Cleared Aug 01, 1985
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
K853073 · GTZ
Marion Laboratories, Inc.
Microbiology · 9d
Cleared Jul 31, 1985
ULTRATHIN/SP LENS
K843957 · HRG
Optical Systems Intl., Inc.
Ophthalmic · 294d
Cleared Jul 31, 1985
TUBULITEC PRIMER
K851052 · LBH
Dental Therapeutics AB
Dental · 139d
Cleared Jul 31, 1985
CUPRIDENT
K851073 · EJR
Bio Systems, Inc.
Dental · 135d
Cleared Jul 31, 1985
TROPHY COMPACT - DENTAL UNIT
K851136 · EIA
Trophy Radiologie
Dental · 132d
Cleared Jul 31, 1985
ANNE MARIE PERRIS SUNGLASSES AND FRAMES
K851698 · HQY
Perlinea Co.
Ophthalmic · 98d
Cleared Jul 31, 1985
OMRON DIGITAL BP MONITOR HEM-400C
K851707 · DXN
Omron Tateisi Electronics Co.
Cardiovascular · 97d
Cleared Jul 31, 1985
RESTORE*
K851929 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 90d
Cleared Jul 31, 1985
COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM
K852102 · CCM
Warren E. Collins, Inc.
Anesthesiology · 77d
Cleared Jul 31, 1985
SITE INFUSION CONTACT LENS W/ILLUMINATOR
K852187
Microsurgical Systems, Inc.
Ophthalmic · 72d
Cleared Jul 31, 1985
DENTAL CASTING ALLOY GDC 1686
K852347 · EJS
Deringer-Ney, Inc.
Dental · 61d
Cleared Jul 31, 1985
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
K852384 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 56d
Cleared Jul 31, 1985
INTERPLAK
K852476 · JEQ
Dental Research Corp.
Dental · 50d
Cleared Jul 31, 1985
SATLEC PROPHY UNIT PU 3055
K852521 · KOJ
Spelna, Inc.
Dental · 47d
Cleared Jul 31, 1985
SATALEC SERVOTORQUE S2 SX2
K852524 · EIA
Spelna, Inc.
Dental · 47d
Cleared Jul 31, 1985
ATL 225 MW TRAIL LENS SET
K852548 · HPA
Ascon Medical Instruments, Ltd.
Ophthalmic · 49d
Cleared Jul 31, 1985
A-COMPANY ELASTIC LIGATURE RINGS
K852596 · ECI
A Company, Inc.
Dental · 42d
Cleared Jul 31, 1985
A-COMPANY ELASTIC ROTATION WEDGES
K852597 · ECI
A Company, Inc.
Dental · 42d
Cleared Jul 31, 1985
A-COMPANY SEPARATING ELASTICS
K852598 · ECI
A Company, Inc.
Dental · 42d
Cleared Jul 31, 1985
A-COMPANY ELASTOMERIC TUBING
K852599 · ECI
A Company, Inc.
Dental · 42d
Cleared Jul 31, 1985
A-COMPANY ELASTOMERIC CHAIN DISPENSER
K852600 · ECI
A Company, Inc.
Dental · 42d
Cleared Jul 31, 1985
A-COMPANY ESPREE SAFETY HEADGEAR
K852670 · DZB
A Company, Inc.
Dental · 37d
Cleared Jul 31, 1985
HEARING AID, UNITRON MODEL UM60-H
K852690 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 36d