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
71281–71304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2003
SONOMA ANTERIOR CERVICAL PLATE SYSTEM
K032368 · KWQ
Seaspine
Orthopedic · 69d
Cleared Oct 09, 2003
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
K032427 · JEC
Meridan Medical
Orthopedic · 64d
Cleared Oct 09, 2003
SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM
K032506 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 56d
Cleared Oct 09, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
K032581 · LPH
Howmedica Osteonics Corp.
Orthopedic · 49d
Cleared Oct 09, 2003
PORT CASSETTE
K032654 · IXK
Orex Computed Radiography, Ltd.
Radiology · 42d
Cleared Oct 09, 2003
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
K032700 · MQP
Blackstone Medical, Inc.
Orthopedic · 37d
Cleared Oct 09, 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724 · MUJ
Adac Laboratories
Radiology · 36d
Cleared Oct 09, 2003
MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
K032768 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 31d
Cleared Oct 09, 2003
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD...
K032789 · FRN
American I.V. Products, Inc.
General Hospital · 31d
Cleared Oct 09, 2003
US-100 PORTABLE ULTRASOUND THERAPY UNIT
K032793 · IMI
Ito Co., Ltd.
Physical Medicine · 30d
Cleared Oct 09, 2003
MAS PAR TDM
K032826 · DIF
Medical Analysis Systems, Inc.
Toxicology · 29d
Cleared Oct 09, 2003
UNOMEDICAL MONICA INFUSION SET
K032854 · FPA
Unomedical A/S
General Hospital · 27d
Cleared Oct 09, 2003
T2 RECON NAIL SYSTEM
K032898 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Oct 09, 2003
SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES
K033160 · JEY
Synthes (Usa)
Dental · 9d
Cleared Oct 08, 2003
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437 · JIL
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Oct 08, 2003
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING
K032605 · KIF
Meta Biomed Co., Ltd.
Dental · 44d
Cleared Oct 08, 2003
ENDOTINE FOREHEAD DEVICE
K032770 · HWC
Coapt Systems, Inc.
Orthopedic · 30d
Cleared Oct 08, 2003
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO...
K032772 · HGM
Hill-Rom Manufacturing, Inc.
Obstetrics & Gynecology · 30d
Cleared Oct 08, 2003
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
K032795 · LNH
Ge Medical Systems, LLC
Radiology · 30d
Cleared Oct 08, 2003
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
K032960 · LLZ
Wide Corporation
Radiology · 15d
Cleared Oct 07, 2003
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
K023366 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 364d
Cleared Oct 07, 2003
NICO WITH MARS, MODEL 7300
K030886 · CCK
Respironics Novametrix, Inc.
Anesthesiology · 200d
Cleared Oct 07, 2003
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · KMF
3M Company
General & Plastic Surgery · 169d
Cleared Oct 07, 2003
VIGORMIST COMPRESSOR NEBULIZER
K031413 · BTI
Vega Technologies, Inc.
Anesthesiology · 155d