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
91033–91056 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1998
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
K974119 · GXZ
Jack'S Electrodes
Neurology · 89d
Cleared Jan 28, 1998
LQUET CANNULA/TROCAR SYSTEM
K974139 · GCJ
Lifequest Endoscopic Technologies, Inc.
General & Plastic Surgery · 86d
Cleared Jan 28, 1998
HM-RUBY
K974142 · GEX
American Lasers, Inc.
General & Plastic Surgery · 86d
Cleared Jan 28, 1998
PARACENTESIS CATHETER DEVICE
K974146 · GCB
Allegiance Healthcare Corp.
General & Plastic Surgery · 86d
Cleared Jan 28, 1998
NARKOMED ULTRASONIC FLOW SENSOR
K974193 · BSZ
Draeger Medical, Inc.
Anesthesiology · 82d
Cleared Jan 28, 1998
DIAMEDIX IS-MEASLES IGG TEST SYSTEM
K974552 · LJB
Diamedix Corp.
Microbiology · 55d
Cleared Jan 28, 1998
STAT TRACKS
K974762 · JJQ
Awareness Technology, Inc.
Chemistry · 40d
Cleared Jan 28, 1998
CARESIDE GLOBULIN
K980055 · JGE
Exigent Diagnostics, Inc.
Chemistry · 22d
Cleared Jan 28, 1998
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
K980135 · JJS
Radiometer America, Inc.
Chemistry · 13d
Cleared Jan 27, 1998
BIOSPECTROMETER-NB OXIMETER IIII
K963903 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 484d
Cleared Jan 27, 1998
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
K973037 · IWJ
Avid N.I.T., Inc.
Radiology · 166d
Cleared Jan 27, 1998
ACTIVATOR II
K973506 · LXM
Activator Methods, Inc.
Physical Medicine · 133d
Cleared Jan 27, 1998
COBE OXYGENATOR PRODUCTS
K974085 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Jan 27, 1998
X-SIGHT DIGITAL IMAGING SYSTEM
K974134 · LLZ
Stallion Technologies, Inc.
Radiology · 85d
Cleared Jan 27, 1998
ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
K974224 · ESZ
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 78d
Cleared Jan 27, 1998
CD-R STATION AND VRS-2000
K974255 · LMD
Electromed Intl., Ltd.
Radiology · 75d
Cleared Jan 27, 1998
MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY
K974308 · MOS
Medrad, Inc.
Radiology · 71d
Cleared Jan 27, 1998
RUSCH SIMPLASTIC COUNCILL TIP CATHETER
K974419 · EZL
Rusch, Inc.
Gastroenterology & Urology · 64d
Cleared Jan 27, 1998
VIROTROL III
K974613 · JJY
Blackhawk Biosystems, Inc.
Microbiology · 47d
Cleared Jan 27, 1998
PERCUPUMP II WITH EDA
K974621 · DSB
E-Z-Em, Inc.
Radiology · 47d
Cleared Jan 27, 1998
BREEZY SERIES
K974820 · IOR
Sunrise Medical, Inc.
Physical Medicine · 35d
Cleared Jan 27, 1998
NON-PRESCRIPTION SUNGLASSES
K974861 · HQY
Wenzhou Hindar Optical Co., Ltd.
Ophthalmic · 29d
Cleared Jan 26, 1998
HUNTLEIGH FP5000 SYSTEM MODEL FP5000
K965153 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 399d
Cleared Jan 26, 1998
CORONARY VEIN GRAFT TAG MARKER
K971966 · KPK
Med-Edge, Inc.
Cardiovascular · 243d