FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71329–71352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 13, 2003
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K031021 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 74d
Cleared Jun 13, 2003
CARESTART HCG ONE-STEP PREGNANCY TEST
K031052 · DHA
Access Bio Incorporate
Chemistry · 72d
Cleared Jun 13, 2003
CORD STICK MULTIPLE DRAW SYSTEM
K031058 · FMI
Cord Stick Corp.
General Hospital · 71d
Cleared Jun 13, 2003
PASCO MIC AND MIC/ID PANELS
K031205 · JWY
Pasco Laboratories, Inc.
Microbiology · 58d
Cleared Jun 13, 2003
VANTAGE ANTERIOR FIXATION SYSTEM
K031533 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jun 12, 2003
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
K023559 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 232d
Cleared Jun 12, 2003
SINGLE USE ORAL MASK, MODEL HC455A
K023670 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 224d
Cleared Jun 12, 2003
BLACKSTONE POSTERIOR CERVICAL SYSTEM
K030197 · KWP
Blackstone Medical, Inc.
Orthopedic · 142d
Cleared Jun 12, 2003
OTI BONE CEMENT PLUG
K030608 · JDK
Osteoimplant Technology, Inc.
Orthopedic · 106d