FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71833–71856 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 16, 2003
CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO...
K031048 · JHI
Access Bio Incorporate
Chemistry · 75d
Cleared Jun 16, 2003
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
K031101 · JJY
Hemagen Diagnostics, Inc.
Chemistry · 70d
Cleared Jun 16, 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031197 · FGE
Cordis Corp.
Gastroenterology & Urology · 61d
Cleared Jun 16, 2003
MODIFICATION TO IVS INTRODUCER SET, MODEL 1003
K031583 · DYB
Integrated Vascular Systems, Inc.
Cardiovascular · 26d
Cleared Jun 13, 2003
PROFILE 1064 LASER SYSTEM
K023881 · GEX
Sciton, Inc
General & Plastic Surgery · 204d
Cleared Jun 13, 2003
RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
K030211 · DKX
Icn Biomedicals, Inc.
Toxicology · 143d
Cleared Jun 13, 2003
FINAL VARNISH LC
K030844 · KLE
Voco GmbH
Dental · 88d
Cleared Jun 13, 2003
LEKTROGEL, MODEL LK3001
K030887 · GYB
Inmed Ltda.
Neurology · 84d