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
128473–128496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1989
WILTEK GASTRIC FEEDING TUBE
K894860 · FPD
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK PAPILLOTOME
K894861 · KNS
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK GRASPING FORCEPS
K894862 · OCZ
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK CYTOLOGY BRUSH
K894863 · FDX
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK BALLOON STONE EXTRACTOR
K894865 · LQR
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK STONE EXTRACTOR
K894866 · LQR
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK E.R.C.P. CATHETER
K894867 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK VARICES INJECTION NEEDLE
K894868 · FBK
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK POLYPECTOMY SNARE
K894869 · FDI
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK NASAL BILIARY DRAINAGE SET
K894870 · BSS
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK BILIARY STENT SET
K894871 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
PLATELIA RUBELLA IGG KIT
K894946 · LFX
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 140d
Cleared Dec 21, 1989
ORTHO-KEV APPLIANCE REINFORCING SYSTEM
K895714 · EBI
American Orthodontics
Dental · 87d
Cleared Dec 21, 1989
BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS
K895748 · KHS
Catachem, Inc.
Chemistry · 86d
Cleared Dec 21, 1989
HEMA-PRIMER
K895750 · KLE
Parkell
Dental · 86d
Cleared Dec 21, 1989
LATEX PATIENT EXAMINATION GLOVES
K895754 · LYY
Frontline Latex Products Pvt. , Ltd.
General Hospital · 84d
Cleared Dec 21, 1989
SILCOT COPAL CAVITY VARNISH
K895798 · EMA
Specialites Septodont
Dental · 84d
Cleared Dec 21, 1989
MODEL 4070 TEMPERATURE MONITOR
K895875 · FLL
Mallinckrodt Anesthesia Products
General Hospital · 78d
Cleared Dec 21, 1989
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR
K896167 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 57d
Cleared Dec 21, 1989
MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN
K896485 · GXY
Empi
Neurology · 38d
Cleared Dec 21, 1989
GYROVIEW HR HIGH RESOLUTION WORKSTATION
K896647 · LNH
Philips Medical Systems North...
Radiology · 27d
Cleared Dec 20, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892194 · LYY
Pao Chen Industrial Co., Ltd.
General Hospital · 253d
Cleared Dec 20, 1989
SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL)
K893800 · EJT
Deringer-Ney, Inc.
Dental · 212d
Cleared Dec 20, 1989
BIOCHEM 3100 OXIMETER
K893877 · DQO
Biochem International, Inc.
Cardiovascular · 208d