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
123049–123072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1991
ANATECH X-RAY GENERATOR
K904114 · IZO
Continental X-Ray Corp.
Radiology · 119d
Cleared Jan 03, 1991
MORSE BALLOON INFLATION DEVICE
K904275 · MAV
North American Instrument Corp.
Cardiovascular · 107d
Cleared Jan 03, 1991
MEDTRONIC MODEL 5301B TEST CABLE
K904602 · DXY
Medtronic Vascular
Cardiovascular · 85d
Cleared Jan 03, 1991
ACS URETHAN CORONARY GUIDING CATHETER
K904884 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 69d
Cleared Jan 03, 1991
MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
K904941 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 63d
Cleared Jan 03, 1991
TITAN GEL
K905149 · DAH
Helena Laboratories
Immunology · 49d
Cleared Jan 03, 1991
IMMUNOWELL TPO (MICROSOME) TEST
K905486 · JNL
General Biometrics, Inc.
Immunology · 28d
Cleared Jan 03, 1991
KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS
K905566 · LMC
Eastman Kodak Company
Radiology · 22d
Cleared Jan 02, 1991
AIROX AXR. 1A
K901953 · CBK
Ferguson Medical
Anesthesiology · 246d
Cleared Jan 02, 1991
DOPPLER OPTION FOR PLATINUM
K902691 · IYN
Philips Medical Systems, Inc.
Radiology · 197d
Cleared Jan 02, 1991
STIMTRAC PC, CATALOG NO. 78-8510
K903128 · GZJ
Stimtech Products
Neurology · 170d
Cleared Jan 02, 1991
ORAL-CATH SUCTION CATHETER
K903552 · BSY
Concord Protex
Anesthesiology · 149d
Cleared Jan 02, 1991
MODEL OSP, SANDHILL AMS
K904231 · FAD
Sandhill Scientific, Inc.
Gastroenterology & Urology · 127d
Cleared Jan 02, 1991
CUSTOMED CARDIOVASCULAR PACK
K904693 · KKX
Customed, Inc.
General Hospital · 78d
Cleared Jan 02, 1991
CUSTOMED ANGIODRAPE PACK FEMORAL
K904694 · KKX
Customed, Inc.
General Hospital · 78d
Cleared Jan 02, 1991
GDC-1501
K904695 · EJT
Deringer-Ney, Inc.
Dental · 78d
Cleared Jan 02, 1991
OXYGEN/AIR TUBING
K904715 · CAF
Tri/Bor Medical, Inc.
Anesthesiology · 76d
Cleared Jan 02, 1991
AERO-GEN NEBULIZER
K904716 · CAF
Tri/Bor Medical, Inc.
Anesthesiology · 76d
Cleared Jan 02, 1991
DISPOSABLE FACE MASK
K904719 · BYG
Tri/Bor Medical, Inc.
Anesthesiology · 76d
Cleared Jan 02, 1991
VISTAR
K905070 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 54d
Cleared Jan 02, 1991
TPN FLUID TRANSFER SET
K905201 · LHI
Mcgaw, Inc.
General Hospital · 43d
Cleared Jan 02, 1991
LANEX EXAM GLOVES
K905667 · LYY
Mokiem & Julian Industrial Corp.
General Hospital · 15d
Cleared Jan 01, 1991
PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC
K896851 · JDI
Lima Intl. Corp.
Orthopedic · 392d
Cleared Dec 31, 1990
ORION STERILE OR TOWELS
K903117 · KKX
Orion Life Systems, Inc.
General Hospital · 168d