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
67921–67944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2004
POWERED WHEELCHAIR, MODEL C-1000
K041211 · ITI
Otto Bock Healthcare LP
Physical Medicine · 144d
Cleared Oct 01, 2004
SYNTHES CONTOURED SYNMESH SPACER
K041389 · MQP
Synthes Spine
Orthopedic · 129d
Cleared Oct 01, 2004
E-PAIN CARE
K041714 · FRN
Breg, Inc.
General Hospital · 100d
Cleared Oct 01, 2004
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K041808 · KWP
Endius, Inc.
Orthopedic · 87d
Cleared Oct 01, 2004
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587,...
K041962 · FGE
Abbott Laboratories
Gastroenterology & Urology · 72d
Cleared Oct 01, 2004
M2A MAGNUM SYSTEM
K042037 · KWA
Biomet, Inc.
Orthopedic · 64d
Cleared Oct 01, 2004
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
K042070 · JOX
Medtronic Vascular
Hematology · 60d
Cleared Oct 01, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042402 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Oct 01, 2004
LSO PET/CT HIREZ 64
K042467 · KPS
Cti Pet Systems, Inc.
Radiology · 18d
Cleared Oct 01, 2004
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
K042503 · ETA
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 16d
Cleared Oct 01, 2004
ZILVER 518 BILIARY STENT
K042518 · FGE
Cook, Inc.
Gastroenterology & Urology · 15d
Cleared Oct 01, 2004
CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL...
K042525 · LLZ
Ge Medical Systems Information...
Radiology · 14d
Cleared Sep 30, 2004
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
K040630 · JWH
Implex Corp.
Orthopedic · 204d
Cleared Sep 30, 2004
ERCHONIA EML LASER
K041139 · NHN
Erchonia Medical, Inc.
Physical Medicine · 153d
Cleared Sep 30, 2004
STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM
K041651 · DZE
Stryker Leibinger
Dental · 105d
Cleared Sep 30, 2004
COOLCUBE COOLPEN
K041767 · GEX
Bruce J. Sand M.D.
General & Plastic Surgery · 92d
Cleared Sep 30, 2004
AZ ULTRASONIC SYSTEM
K042056 · ELC
J. Morita USA, Inc.
Dental · 62d
Cleared Sep 30, 2004
SHOULDER FIXATION SYSTEM
K042059 · LXT
Hand Innovations, Inc.
Orthopedic · 62d
Cleared Sep 30, 2004
PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
K042062 · KCT
Bard Peripheral Vascular, Inc.
General Hospital · 59d
Cleared Sep 30, 2004
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
K042065 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 59d
Cleared Sep 30, 2004
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
K042226 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 44d
Cleared Sep 30, 2004
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS...
K042267 · MSH
Inovel, LLC
General Hospital · 38d
Cleared Sep 30, 2004
PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
K042364 · OLV
Lamont Medical, Inc.
Neurology · 30d
Cleared Sep 30, 2004
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K042424 · JLX
Wallac OY
Chemistry · 22d