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
71449–71472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2003
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
K032635 · LMC
Agfa Corp.
Radiology · 29d
Cleared Sep 24, 2003
MODIFICATION TO: AURORA
K032678 · LNH
Aurora Imaging Technology, Inc.
Radiology · 26d
Cleared Sep 24, 2003
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
K032681 · LMC
Konica Medical and Graphic Corporation
Radiology · 26d
Cleared Sep 24, 2003
INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC
K032780 · MEG
Inviro Medical
General Hospital · 16d
Cleared Sep 23, 2003
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
K023429 · MNW
Rowenta, Inc.
Gastroenterology & Urology · 347d
Cleared Sep 23, 2003
PALACOS R
K030902 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 183d
Cleared Sep 23, 2003
OSTEOPAL
K030903 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 183d
Cleared Sep 23, 2003
PALAMED
K030904 · LOD
Heraeus Medical GmbH Technology
Orthopedic · 183d
Cleared Sep 23, 2003
CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
K030966 · NAJ
Boston Scientific Corp
Obstetrics & Gynecology · 180d
Cleared Sep 23, 2003
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K031214 · KWQ
Encore Medical, L.P.
Orthopedic · 159d
Cleared Sep 23, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031305 · LFL
Olympus Optical Co., Ltd.
General & Plastic Surgery · 152d
Cleared Sep 23, 2003
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE...
K031449 · KWS
Implex Corp.
Orthopedic · 139d
Cleared Sep 23, 2003
S&T MICROSURGICAL SUTURE
K031531 · GAR
S & T AG
General & Plastic Surgery · 131d
Cleared Sep 23, 2003
STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING
K031669 · KGO
P.T. Saptindo Surgica
General Hospital · 117d
Cleared Sep 23, 2003
STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING
K031670 · KGO
P.T. Saptindo Surgica
General Hospital · 117d
Cleared Sep 23, 2003
KSEA OPSERVER LAP
K031895 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 96d
Cleared Sep 23, 2003
PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
K031897 · INI
Imc-Heart Way LLC
Physical Medicine · 96d
Cleared Sep 23, 2003
VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
K031944 · LZA
Arista Latindo Industrial Ltd. P.T
General Hospital · 91d
Cleared Sep 23, 2003
PERSONNA PLUS SAFETY SCALPEL SYSTEM
K032242 · GES
Omi Manufacturing Pty., Ltd.
General & Plastic Surgery · 64d
Cleared Sep 23, 2003
MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932)
K032364 · FLL
Microlife Intellectual Property GmbH
General Hospital · 54d
Cleared Sep 23, 2003
F-11 FOLDING POWER CHAIR
K032440 · ITI
Wheelchair & Scooter Express
Physical Medicine · 47d
Cleared Sep 23, 2003
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
K032468 · GAQ
Suturtek Incorporated
General & Plastic Surgery · 43d
Cleared Sep 23, 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS...
K032553 · HCG
Cordis Neurovascular, Inc.
Neurology · 35d
Cleared Sep 23, 2003
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6...
K032606 · JWH
Exactech, Inc.
Orthopedic · 29d