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
125929–125952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1990
LATEX CONDOMS - CODE NO. 403, 406, 421 & 1033
K901696 · HIS
Allercare/Nsl, Inc.
Obstetrics & Gynecology · 34d
Cleared May 16, 1990
MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE
K902016 · LYU
Aor-Sullivan
General Hospital · 16d
Cleared May 15, 1990
KING OF HEARTS CDM
K896040 · DXH
Instromedix, Inc.
Cardiovascular · 211d
Cleared May 15, 1990
BIOMER(R) F COMPOSITE LUTING CEMENT
K896340 · EMA
Dentsply Intl.
Dental · 193d
Cleared May 15, 1990
CELLOGNOST SYPHILIS H
K896410 · GMT
Behring Diagnostics, Inc.
Microbiology · 189d
Cleared May 15, 1990
PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER
K896481 · MCF
Purebrush Assoc.
Dental · 181d
Cleared May 15, 1990
INTERFACE BONDING SYSTEM
K896769 · EBF
Smile Horizons, Inc.
Dental · 165d
Cleared May 15, 1990
PALFIQUE LIGHT LINER
K896980 · EBI
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
TOKUSO REBASE
K896981 · EBI
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
PALFIQUE LIGHT BONDING AGENT
K897009 · KLE
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
PALFIQUE LIGHT COMPOSITE RESIN
K897010 · EBF
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
PALFIQUE LIGHT-S COMPOSITE RESIN
K897011 · EBF
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
NOVUS BONDING AGENT
K900301 · EBI
The Hygenic Corp.
Dental · 113d
Cleared May 15, 1990
MEDILASE 5010 ENDOSCOPE CONSOLE
K900380 · FET
Medical Laser, Inc.
Gastroenterology & Urology · 109d
Cleared May 15, 1990
VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
K900688 · LFY
Clinical Sciences, Inc.
Microbiology · 91d
Cleared May 15, 1990
EPI DENT TOOTHBRUSH
K900766 · JEQ
Epi Mfg.
Dental · 88d
Cleared May 15, 1990
COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS
K900799 · EBI
Comfort Acrylics Co.
Dental · 84d
Cleared May 15, 1990
ANTI-HUMAN LEU-3A (CD4) FITC
K900802 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 84d
Cleared May 15, 1990
HEMODIALYSIS TRANSDUCER PROTECTOR
K900841 · FIB
Mediflex Intl.
Gastroenterology & Urology · 82d
Cleared May 15, 1990
ENZYMUN TEST(R) FT4 (FREE THYROXINE)
K900883 · CEC
Boehringer Mannheim Corp.
Chemistry · 78d
Cleared May 15, 1990
ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER
K900887 · CGZ
Abbott Laboratories
Chemistry · 78d
Cleared May 15, 1990
LOCKBOX
K900888 · FRN
Pharmacia Deltec, Inc.
General Hospital · 78d
Cleared May 15, 1990
CODERE-DURETTE ORBITAL FLOOR IMPLANT
K900927 · HQX
Oculo Plastik, Inc.
Ophthalmic · 77d
Cleared May 15, 1990
COX MALAR EMINENCE IMPLANTS
K900928 · HQX
Oculo Plastik, Inc.
Ophthalmic · 77d