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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
40561–40584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2013
HUMELOCK II CEMENTED SHOULDER SYSTEM
K123814 · KWT
Fx Solutions
Orthopedic · 244d
Cleared Aug 13, 2013
EASYSTAND BANTAM MEDIUM
K123834 · INO
Altimate Medical, Inc.
Physical Medicine · 243d
Cleared CT Aug 13, 2013
SOFIA(R) RSV FIA
K130398 · GQG
Quidel Corp.
Microbiology · 175d
Cleared Aug 13, 2013
OPTIFLOW II FLOWABLE COMPOSITE, LC
K130672 · EBF
Pac-Dent International, Inc.
Dental · 154d
Cleared Aug 13, 2013
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER...
K130682 · DZL
Hager& Meisinger GmbH
Dental · 153d
Cleared Aug 13, 2013
S4C NAVIGATION INSTRUMENTS
K130887 · OLO
Aesculap Implant System, Inc.
Orthopedic · 137d
Cleared Aug 13, 2013
EVICEL APPLICATION DEVICE
K130900 · FMF
Ethicon Inc (On Behalf of Omrix...
General Hospital · 134d
Cleared Aug 13, 2013
EXTRICARE NPWT FOOT DRESSING
K131464 · OMP
Devon Medical, Inc.
General & Plastic Surgery · 84d
Cleared Aug 12, 2013
FAHL TRACHEOSTOMY TUBES (MULTIPLE)
K123699 · JOH
Andreas Fahl Medizintechnik-Vertrieb...
Anesthesiology · 252d
Cleared Aug 12, 2013
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE...
K123864 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 238d
Cleared CT Aug 12, 2013
SPARTAN RX CYP2C19 TEST SYSTEM
K123891 · NTI
Spartan Bioscience, Inc.
Toxicology · 237d
Cleared Aug 12, 2013
PANA SPRAY PLUS
K131014 · EFB
Nsk America Corp.
Dental · 123d
Cleared Aug 12, 2013
PHILIPS SURESIGNS CENTRAL
K131032 · MHX
Philips Medical Systems
Cardiovascular · 122d
Cleared Aug 12, 2013
VIVORTE BVF LITE
K131133 · MQV
Vivorte, Inc.
Orthopedic · 111d
Cleared Aug 12, 2013
ELECTROMAGNETIC TRANSMITTING STYLET
K131532 · KNT
Corpak Medsystems
Gastroenterology & Urology · 76d
Cleared Aug 12, 2013
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
K131536 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 75d
Cleared Aug 12, 2013
CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER
K132197 · DQY
Pendracare International, B.V.
Cardiovascular · 27d
Cleared Aug 09, 2013
E-TENG MODEL EOR 1
K122562 · IPL
E-Teng Technology, Inc.
Physical Medicine · 352d
Cleared Aug 09, 2013
PROFTHAND MECHANICAL WHEELCHAIR
K123076 · IOR
Harmony Hill International
Physical Medicine · 312d
Cleared Aug 09, 2013
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
K123553 · KCY
Zimmer, Inc.
General & Plastic Surgery · 263d
Cleared Aug 09, 2013
SUREFIX INTERSPINOUS FUSION SYSTEM
K124014 · PEK
Jg Spine, LLC
Orthopedic · 225d
Cleared CT Aug 09, 2013
CROSSTREES PVA POD
K130089 · NDN
Crosstrees Medical, Inc.
Orthopedic · 207d
Cleared Aug 09, 2013
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
K130484 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 165d
Cleared Aug 09, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
K130685 · JFJ
Hitachi Chemical Diagnostics, Inc.
Chemistry · 149d