FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93961–93984 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1997
P.H.D. - PERSONAL HEART DEVICE MODEL 5258
K963904 · DXH
Heart Alert, Inc.
Cardiovascular · 227d
Cleared May 15, 1997
AMBU SPUR NEONATE
K964584 · BTM
Ambu, Inc.
Anesthesiology · 181d
Cleared May 15, 1997
HEWLETT-PACKARD CENTRALVUE SOFTWARE
K964832 · DSI
Hewlett-Packard Co.
Cardiovascular · 164d
Cleared May 15, 1997
NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S,...
K970639 · GXY
Medicotest, Inc.
Neurology · 84d
Cleared May 15, 1997
700-SP SERIES DISPOSABLE STIMULATION ELECTRODES
K971148 · MKJ
Cardiotronics Systems, Inc.
Cardiovascular · 48d
Cleared May 15, 1997
QUANTUM 3080SP SURGICAL TABLE
K971390 · GDC
STERIS Corporation
General & Plastic Surgery · 31d
Cleared May 14, 1997
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
K964518 · DYB
Daig Corp.
Cardiovascular · 201d
Cleared May 14, 1997
ODYSSEY I DENTAL WATER UNIT
K964796 · EIA
Germiphene Corp.
Dental · 166d
Cleared May 14, 1997
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K964869 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 161d
Cleared May 14, 1997
MODEL 405T WITH ETCO2 OPTION
K964961 · CCK
Ivy Biomedical Systems, Inc.
Anesthesiology · 154d
Cleared May 14, 1997
D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES
K965052 · LPL
Wesley Jessen Corp.
Ophthalmic · 147d
Cleared May 14, 1997
CALTAG CAL-LYSE
K965232 · GKZ
Caltag Laboratories, Inc.
Hematology · 134d
Cleared May 14, 1997
REST X SYSTEM
K970428 · FNM
Restxsys
General Hospital · 99d
Cleared May 14, 1997
MYERSON'S ECONOMY DENTURE BASE MATERIAL
K970522 · EBI
Austenal, Inc.
Dental · 92d
Cleared May 14, 1997
TENOSNARE
K970562 · HRX
Luxtec Corp.
Orthopedic · 90d
Cleared May 14, 1997
MODEL 1700, HYDRO PREP
K970694 · GYB
Physiometrix, Inc.
Neurology · 78d
Cleared May 14, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)
K970784 · DXG
Alexander Mfg. Co.
Cardiovascular · 71d
Cleared May 14, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
K970787 · DPS
Alexander Mfg. Co.
Cardiovascular · 71d
Cleared May 14, 1997
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)
K970799 · LIF
Alexander Mfg. Co.
Gastroenterology & Urology · 71d
Cleared May 14, 1997
SCANRITE DFS
K970850 · EHD
Scanrite Systems
Radiology · 68d
Cleared May 14, 1997
CEDIA DIGOXIN
K970881 · KXT
Boehringer Mannheim Corp.
Toxicology · 65d
Cleared May 14, 1997
B-350 CEILING MOUNTED C-POSITIONER
K970947 · JAA
Omega Medical Imaging, Inc.
Radiology · 61d
Cleared May 14, 1997
EPISTAXIS NASAL PACK
K971000 · EMX
Invotec International, Inc.
Ear, Nose, Throat · 56d
Cleared May 14, 1997
QUIKPAC II ONE STEP AMPHETAMINE TEST
K971109 · DKZ
Drial Consultants, Inc.
Toxicology · 49d