Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
72097–72120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2003
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K030442 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 160d
Cleared Jul 21, 2003
ENDOS DC
K030634 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 144d
Cleared Jul 21, 2003
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K030926 · FZP
Advanced Surgical Products, Inc.
General & Plastic Surgery · 119d
Cleared Jul 21, 2003
GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)
K031085 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 108d
Cleared Jul 21, 2003
MODIFICATION TO STRYKER PAINPUMP
K031249 · FRN
Stryker Instruments
General Hospital · 94d
Cleared Jul 21, 2003
DUNLEE FORMAT COLLIMATOR FAMILY
K031597 · IZW
Philips Medical Systems North America...
Radiology · 61d
Cleared Jul 21, 2003
SLED CURING LIGHT SYSTEM
K031615 · EBZ
Dentsply International
Dental · 59d
Cleared Jul 21, 2003
CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION
K031638 · LLZ
Electromed Imaging, Inc.
Radiology · 55d
Cleared Jul 21, 2003
CORIX 70 PLUS-USV
K031802 · EHD
Coramex, S.A.
Radiology · 40d
Cleared Jul 21, 2003
CARDIOVATIONS OPTICAL BIPOLAR DEVICE
K031846 · GEI
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Jul 21, 2003
CARDIOVATIONS RETRACTOR
K031847 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Jul 21, 2003
BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE...
K031912 · LON
Becton, Dickinson & CO
Microbiology · 31d
Cleared Jul 21, 2003
AMPLAID A756 SCREENING ADMITTANCE METER
K031978 · ETY
Amplaid
Ear, Nose, Throat · 25d
Cleared Jul 21, 2003
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
K032114 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared Jul 21, 2003
BRODA MODEL 587 MANUAL WHEELCHAIR
K032133 · IOR
Broda Ent., Inc.
Physical Medicine · 10d
Cleared Jul 21, 2003
SITE-RITE IV ULTRASOUND SYSTEM
K032135 · IYO
Dymax Corp
Radiology · 10d
Cleared Jul 18, 2003
DIADEXUS PLAC TEST
K030477 · NOE
Diadexus, Inc.
Chemistry · 155d
Cleared Jul 18, 2003
PROVIDENCE MOLDING HELMET
K030669 · MVA
Northeast Orthotics and Prothetics, Inc.
Neurology · 137d
Cleared Jul 18, 2003
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
K031057 · JOH
Portex, Inc.
Anesthesiology · 106d
Cleared Jul 18, 2003
PRIMA III TOTALSENSE TORSO COIL
K031365 · MOS
Usa Instruments, Inc.
Radiology · 79d
Cleared Jul 18, 2003
HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS
K031477 · LPL
Ocular Sciences, Inc.
Ophthalmic · 70d
Cleared Jul 18, 2003
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
K031504 · KNG
Koven Technology, Inc.
Radiology · 65d
Cleared Jul 18, 2003
BRAIN COIL, MODEL 9900GE-64
K031536 · MOS
Clinical MR Solutions, LLC
Radiology · 63d
Cleared Jul 18, 2003
STEREOTACTIC BODY FRAME, MODEL COD. 70-1A
K031631 · IYE
3D Line USA, Inc.
Radiology · 52d