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
93337–93360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1997
IMMULITE PYRILINKS-D
K971312 · JMM
Diagnostic Products Corp.
Chemistry · 48d
Cleared May 27, 1997
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
K971477 · CDQ
Trace America, Inc.
Chemistry · 34d
Cleared May 27, 1997
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K971485 · CDO
Trace America, Inc.
Chemistry · 34d
Cleared May 27, 1997
QUANTEX ASO-CRP-RF CONTROL
K971777 · JJT
Instrumentation Laboratory CO
Chemistry · 13d
Cleared May 23, 1997
RUSCH ENTERAL FEEDING TUBE
K963779 · FPD
Rusch, Inc.
Gastroenterology & Urology · 245d
Cleared May 23, 1997
CENTOCOR CA 15-3 RIA MODEL NO. 800-033
K963803 · MOI
Centocor, Inc.
Immunology · 242d
Cleared May 23, 1997
OCCLUSION CLAMP** DEVICE
K964251 · DXC
United States Surgical, A Division of...
Cardiovascular · 211d
Cleared May 23, 1997
BETTER-BLADDER (BB)
K964337 · FIB
Circulatory Technology, Inc.
Gastroenterology & Urology · 204d
Cleared May 23, 1997
STA D-DI CALIBRATOR KIT
K964718 · DAP
American Bioproducts Co.
Hematology · 179d
Cleared May 23, 1997
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
K970077 · KPI
Utah Medical Products, Inc.
Gastroenterology & Urology · 134d
Cleared May 23, 1997
#ES-32 SUCTION CATHETER 32 FR.
K970890 · KNT
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 73d
Cleared May 23, 1997
AUTO HDL CHOLESTEROL CALIBRATOR
K970933 · JIS
Pointe Scientific, Inc.,
Chemistry · 71d
Cleared May 23, 1997
ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR
K971100 · EIA
Atrion Medical Products, Inc.
Dental · 58d
Cleared May 23, 1997
ENDO SMARTCAP (100501)
K971125 · OCX
Endo Smart Cap Co.
Gastroenterology & Urology · 57d
Cleared May 23, 1997
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
K971275 · FDI
Mill-Rose Laboratory
Gastroenterology & Urology · 46d
Cleared May 23, 1997
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT,...
K971333 · JIX
Beckman Instruments, Inc.
Chemistry · 43d
Cleared May 23, 1997
VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
K971415 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 36d
Cleared May 23, 1997
VINYL PATIENT EXAMINATION GLOVE, POWDERED
K971423 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 36d
Cleared May 23, 1997
CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
K971584 · OCV
Clarus Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared May 23, 1997
MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT
K971658 · DBL
Jay H. Geller
Immunology · 39d
Cleared May 22, 1997
VECTORVISION
K962939 · HAW
Brainlab, Inc.
Neurology · 297d
Cleared May 22, 1997
BIO-ANCHOR
K963369 · MAI
Linvatec Corp.
Orthopedic · 268d
Cleared May 22, 1997
OSMOCYTE WOUND MANAGER SHEET DRESSING
K965143 · MGQ
Procyte Corp.
General & Plastic Surgery · 150d
Cleared May 22, 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF...
K970257 · HSB
Ferguson Medical
Orthopedic · 119d