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
72409–72432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2003
C-1805M
K023815 · EIA
Anodia Systems
Dental · 216d
Cleared Jun 19, 2003
C-1890
K023896 · EIA
Anodia Systems
Dental · 209d
Cleared Jun 19, 2003
MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL...
K024093 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 190d
Cleared Jun 19, 2003
CP MEDICAL BONE WAX
K024372 · MTJ
Cp Medical
General & Plastic Surgery · 170d
Cleared Jun 19, 2003
GENICON LAPAROSCOPES
K030174 · GCJ
Genicon, LC
General & Plastic Surgery · 153d
Cleared Jun 19, 2003
DISPOSABLE M2-PE MICROKERATOME BLADES
K030401 · HNO
Oasis Medical, Inc.
Ophthalmic · 133d
Cleared Jun 19, 2003
SKINSTATION
K030897 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 90d
Cleared Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900 · HWC
Inion , Ltd.
Orthopedic · 87d
Cleared Jun 19, 2003
UFI GEL HARD C
K030916 · EBI
Voco GmbH
Dental · 87d
Cleared Jun 19, 2003
HEMCON BANDAGE OTC
K030946 · QSY
Hemcon, Inc.
General & Plastic Surgery · 85d
Cleared Jun 19, 2003
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K031029 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 79d
Cleared Jun 19, 2003
FLUENCY TRACHEOBRONCHIAL STENT GRAFT
K031041 · JCT
Bard Peripheral Vascular
General & Plastic Surgery · 79d
Cleared Jun 19, 2003
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
K031164 · DTD
Oscor, Inc.
Cardiovascular · 66d
Cleared Jun 19, 2003
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
K031177 · MSV
Axis-Shield Diagnostics, Ltd.
Immunology · 66d
Cleared Jun 19, 2003
SOLUTION FACE MASKS
K031353 · FXX
A Plus International, Inc.
General Hospital · 51d
Cleared Jun 19, 2003
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
K031571 · IZQ
E-Z-Em, Inc.
Radiology · 30d
Cleared Jun 19, 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K031626 · LJS
AngioDynamics, Inc.
General Hospital · 23d
Cleared Jun 18, 2003
DEMETECH NYLON NONABSORBABLE SUTURE
K023028 · GAR
Demetech Corp.
General & Plastic Surgery · 280d
Cleared Jun 18, 2003
DEMETECH POLYESTER NONABSORBABLE SUTURE
K023030 · GAT
Demetech Corp.
General & Plastic Surgery · 280d
Cleared Jun 18, 2003
QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
K023335 · NJW
Qc Sciences, LLC
Pathology · 254d
Cleared Jun 18, 2003
ULTRA HIGH PRESSURE INJECTOR LINES
K023591 · DQO
Deroyal Industries, Inc.
Cardiovascular · 236d
Cleared Jun 18, 2003
GYNE IDEAS MINITAPE RP DEVICE
K023898 · PAH
Gyne Ideas , Ltd.
Gastroenterology & Urology · 208d
Cleared Jun 18, 2003
CURAD SCAR THERAPY
K024057 · MDA
Beiersdorf, Inc.
General & Plastic Surgery · 191d
Cleared Jun 18, 2003
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K030654 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 107d