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

Filters: Cleared only ×
176,076 results
72457–72480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 12, 2003
HA PMI FLANGED ACETABULAR COMPONENT
K030861 · LPH
Biomet, Inc.
Orthopedic · 86d
Cleared Jun 12, 2003
CONTACT LENS STORAGE CASE
K030987 · LRX
Pelican Products
Ophthalmic · 76d
Cleared Jun 12, 2003
NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES...
K030993 · LYY
Sgmp Co., Ltd.
General Hospital · 76d
Cleared Jun 12, 2003
NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH &...
K030994 · LYY
Sgmp Co., Ltd.
General Hospital · 76d
Cleared Jun 12, 2003
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500
K031083 · HTY
Opus Medical, Inc.
Orthopedic · 69d
Cleared Jun 12, 2003
PASCO MIC AND MIC/ID PANELS (ERTAPENEM)
K031103 · JWY
Pasco Laboratories, Inc.
Microbiology · 66d
Cleared Jun 12, 2003
PORTA PRESSOVER
K031264 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d