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

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176,076 results
68617–68640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2004
PRO WALKER PL-200 POWER WHEELCHAIR
K041336 · ITI
Pro Walker, Inc.
Physical Medicine · 62d
Cleared Jul 20, 2004
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054
K041376 · MWI
Analogic Corp.
Cardiovascular · 57d
Cleared Jul 20, 2004
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR,...
K041417 · NBC
Dade Behring, Inc.
Chemistry · 54d
Cleared Jul 20, 2004
FS SERIES WHEELCHAIR
K041814 · IOR
Foshan Dongfang Medical Equipment...
Physical Medicine · 14d
Cleared Jul 19, 2004
MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM
K033897 · ECX
Aga-Linde Health Care
Anesthesiology · 216d
Cleared Jul 19, 2004
GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION...
K040010 · QEW
Genesis Medical Interventional, Inc.
Cardiovascular · 196d
Cleared Jul 19, 2004
EXPEDIUM SPINE SYSTEM
K041119 · KWP
Depuy Spine, Inc.
Orthopedic · 81d
Cleared Jul 19, 2004
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
K041174 · MVM
Sweden Diagnostics (Germany) GmbH
Immunology · 75d
Cleared Jul 19, 2004
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
K041317 · LZG
Medtronic Minimed
General Hospital · 62d
Cleared Jul 19, 2004
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
K041318 · LZG
Medtronic Minimed
General Hospital · 62d
Cleared Jul 19, 2004
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER
K041324 · LYC
Lifecore Biomedical, Inc.
Dental · 62d
Cleared Jul 19, 2004
MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
K041338 · MWS
Medtronic Vascular
Cardiovascular · 60d
Cleared Jul 19, 2004
MODEL BBC-127 BIOPSY BREAST COIL
K041481 · MOS
Mri Devices Corp.
Radiology · 46d
Cleared Jul 19, 2004
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
K041674 · DQA
Philips Medical Systems
Anesthesiology · 28d
Cleared Jul 19, 2004
C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM
K041794 · KWQ
Interpore Cross Intl.
Orthopedic · 17d
Cleared Jul 19, 2004
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
K041816 · DRG
Rtx Healthcare A/S
Cardiovascular · 13d
Cleared Jul 16, 2004
MERLIN RESUSCITATOR
K031395 · BTM
Merlin Medical Limited
Anesthesiology · 441d
Cleared Jul 16, 2004
BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST...
K040466 · MVM
The Binding Site
Immunology · 144d
Cleared Jul 16, 2004
ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256
K040554 · GWQ
Manufacturing Technology, Inc.
Neurology · 136d
Cleared Jul 16, 2004
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
K040851 · HPZ
Porex Surgical, Inc.
Ophthalmic · 107d
Cleared Jul 16, 2004
MODIFICATION TO ENCOMPASS
K040896 · LLZ
Heartlab, Inc.
Radiology · 101d
Cleared Jul 16, 2004
SPLIT SEPTUM INJECTION SITES
K041042 · FPA
Fresenius Medical Care North America
General Hospital · 85d
Cleared Jul 16, 2004
MAGNETOM C! MR SYSTEM
K041111 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Jul 16, 2004
EMPOWER TRANSFER SET, (CAT. NO. 7725)
K041178 · FPK
E-Z-Em, Inc.
General Hospital · 72d