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
72433–72456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2003
OMNILUX BLUE
K030883 · GEX
Photo Therapeutics Limited
General & Plastic Surgery · 90d
Cleared Jun 18, 2003
LUMEND FRONTRUNNER GW CTO CATHETER
K031005 · PDU
Lumend, Inc.
Cardiovascular · 79d
Cleared Jun 18, 2003
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS...
K031231 · JJW
Bio-Rad
Chemistry · 61d
Cleared Jun 18, 2003
ANDIODYNAMICS, INC. ELVS PROCEDURE KIT
K031233 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 62d
Cleared Jun 18, 2003
LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
K031443 · NEW
Lsi Solutions
General & Plastic Surgery · 43d
Cleared Jun 18, 2003
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
K031452 · KWP
Ortho Tec, LLC
Orthopedic · 42d
Cleared Jun 18, 2003
NIM-SPINE
K031510 · ETN
Medtronic Xomed
Ear, Nose, Throat · 35d
Cleared Jun 18, 2003
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · HRX
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Jun 17, 2003
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
K023666 · FGE
Rusch Intl.
Gastroenterology & Urology · 229d
Cleared Jun 17, 2003
TENS PRO 900
K023726 · GZJ
Acumed Medical Supplies , Ltd.
Neurology · 223d
Cleared Jun 17, 2003
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
K030099 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 158d
Cleared Jun 17, 2003
ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
K030528 · JIY
Clinical Data
Chemistry · 118d
Cleared Jun 17, 2003
MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK...
K030531 · LZG
Minimed, Inc.
General Hospital · 118d
Cleared Jun 17, 2003
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
K030891 · HNO
Surgistar, Inc.
Ophthalmic · 88d
Cleared Jun 17, 2003
VMATE MODEL VMM1000
K030948 · HQE
Howard Instruments, Inc.
Ophthalmic · 83d
Cleared Jun 17, 2003
ONE-STEP PREGNANCY TEST
K031271 · LCX
Amerisource Pharmacal, Inc.
Chemistry · 56d
Cleared Jun 17, 2003
IMAGINE REFLEX
K031326 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d
Cleared Jun 17, 2003
MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR,...
K031384 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 47d
Cleared Jun 17, 2003
URINARY CATHETERS
K031409 · GBM
Promedic, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 17, 2003
PHILIPS EASYDIAGNOST ELEVA
K031535 · KPR
Philips Medical Systems North America...
Radiology · 32d
Cleared Jun 17, 2003
LORENZE EXTERNAL MANDIBULAR DISTRACTOR
K031696 · MQN
Walter Lorenz Surgical, Inc.
Dental · 15d
Cleared Jun 17, 2003
SKYLIGHT IMAGING SYSTEM
K031705 · KPS
Adac Laboratories
Radiology · 15d
Cleared Jun 16, 2003
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER
K030020 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 164d
Cleared Jun 16, 2003
VIDAS TROPONIN I (TNI), MODEL 30 445
K030950 · MMI
bioMerieux, Inc.
Chemistry · 82d