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
73753–73776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2003
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
K022143 · MQP
Interpore Cross Intl.
Orthopedic · 205d
Cleared Jan 23, 2003
BARD ER URETERAL STENT WITH SUTURE
K022447 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 181d
Cleared Jan 23, 2003
DRX3000
K022602 · ITH
Axiom Usa., Inc.
Physical Medicine · 170d
Cleared Jan 23, 2003
LUMEND FRONTRUNNER CTO CATHETER
K023114 · PDU
Lumend, Inc.
Cardiovascular · 126d
Cleared Jan 23, 2003
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
K023613 · IXW
Alphatek Corp.
Radiology · 87d
Cleared Jan 23, 2003
DIMISIL SCAR GEL
K023678 · MDA
Aesthetic and Reconstructive...
General & Plastic Surgery · 83d
Cleared Jan 23, 2003
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · KWY
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Jan 23, 2003
XENO III DENTAL ADHESIVE
K023776 · KLE
Dentsply Intl.
Dental · 72d
Cleared Jan 23, 2003
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804 · KWP
Depuyacromed
Orthopedic · 70d
Cleared Jan 23, 2003
RAPID THERMAL EXCHANGE SYSTEM
K023934 · DWJ
Avacore Technologies, Inc.
Cardiovascular · 58d
Cleared Jan 23, 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941 · KTT
Synthes (Usa)
Orthopedic · 58d
Cleared Jan 23, 2003
OSTEO-CABLE SLEEVE
K024022 · HXN
Biomet, Inc.
Orthopedic · 49d
Cleared Jan 23, 2003
ASCENSIA GLUCOFACTS
K024234 · NBW
Bayer Corp.
Chemistry · 31d
Cleared Jan 23, 2003
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K024326 · KWQ
Spinal Concepts, Inc.
Orthopedic · 28d
Cleared Jan 23, 2003
FREEDOM CONSTRAINED LINERS
K030047 · KWZ
Biomet, Inc.
Orthopedic · 17d
Cleared Jan 23, 2003
TRIAGE CARDIAC CONTROLS
K030089 · JJY
Biosite Incorporated
Chemistry · 13d
Cleared Jan 22, 2003
EXEL SECURETOUCH PTP SYRINGE
K011754 · MEG
Exelint Intl. Co.
General Hospital · 595d
Cleared Jan 22, 2003
STRYKER NAVIGATION SYSTEM - HIP MODULE
K022365 · HAW
Stryker Instruments
Neurology · 184d
Cleared Jan 22, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K022884 · GEX
Candela Corp.
General & Plastic Surgery · 145d
Cleared Jan 22, 2003
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K023128 · HIS
Secure Scientific Sdn Bhd
Obstetrics & Gynecology · 125d
Cleared Jan 22, 2003
CONCERT CRANIOPLAST
K023575 · GXP
Immedica, Inc.
Neurology · 90d
Cleared Jan 22, 2003
SONICAID ONE
K023618 · HGM
Oxford Instruments Medical , Ltd.
Obstetrics & Gynecology · 85d
Cleared Jan 22, 2003
EXAJET
K023751 · ELW
GC America, Inc.
Dental · 75d
Cleared Jan 22, 2003
SYDNEY IVF EMBRYO BIOPSY MEDIUM
K023850 · MQL
Cook Ob/Gyn
Obstetrics & Gynecology · 64d