FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126529–126552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 15, 1990
SPIVEY-ALLEN ORBITAL FLOOR IMPLANT
K900930 · HQX
Oculo Plastik, Inc.
Ophthalmic · 77d
Cleared May 15, 1990
DU PONT LINX LASER IMAGER W/THE LINX NETWORKING
K900935 · LMD
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 76d
Cleared May 15, 1990
VISUWELL(R) CHLAMYDIA
K900973 · LJC
Adi Diagnostics, Inc.
Microbiology · 74d
Cleared May 15, 1990
SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
K900991 · EFS
Tocad America, Inc.
Dental · 74d
Cleared May 15, 1990
DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
K901017 · JFJ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 71d
Cleared May 15, 1990
SUNGLASSES
K901047 · HQY
Command Marketing Corp.
Ophthalmic · 70d
Cleared May 15, 1990
EDENTEC MODEL 2000W SYSTEM 700 MONITOR
K901060 · DQA
Edentec Corp.
Anesthesiology · 70d
Cleared May 15, 1990
NON-PRESCRIPTION SUNGLASSES
K901168 · HQY
Renauld Intl. , Ltd.
Ophthalmic · 63d
Cleared May 15, 1990
TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE
K901239 · EFB
Teledyne Getz
Dental · 61d
Cleared May 15, 1990
CELEBRITY-CARENZA-SUNGEAR-SUMMIT SUNGLASSES
K901299 · HQY
Sun Mark, Inc.
Ophthalmic · 56d