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
72601–72624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2003
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K031286 · GAM
Aesculap, Inc.
General & Plastic Surgery · 36d
Cleared May 29, 2003
THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20
K031481 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 17d
Cleared May 28, 2003
WATER PURIFICATION SYSTEM
K022448 · FIP
Purity Water Company of San Antonio,...
Gastroenterology & Urology · 306d
Cleared May 28, 2003
PAPILLON MASK SET
K023068 · BZD
Map Medizintechnik Fur Arzt Und...
Anesthesiology · 254d
Cleared May 28, 2003
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
K023662 · MCF
Hwadong International Company , Ltd.
Dental · 209d
Cleared May 28, 2003
ENCORE ANTERIOR SPINAL STAPLE SYSTEM
K030667 · KWQ
Encore Medical, L.P.
Orthopedic · 86d
Cleared May 28, 2003
IN-VISION IMAGING SYSTEM
K031148 · DXK
Jomed, Inc.
Cardiovascular · 48d
Cleared May 28, 2003
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K031219 · HSB
Orthofix, Inc.
Orthopedic · 41d
Cleared May 27, 2003
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
K012889 · MED
Pascal Co., Inc.
General Hospital · 637d
Cleared May 27, 2003
COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM
K023937 · DYB
Cook Vascular, Inc.
Cardiovascular · 182d
Cleared May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared May 27, 2003
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618 · BSP
Wilson-Cook Medical, Inc.
Anesthesiology · 90d
Cleared May 27, 2003
APTUS BLUE
K030884 · KJJ
Acadental
Dental · 68d
Cleared May 27, 2003
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K031610 · MCW
Rex Medical
Cardiovascular · 5d
Cleared May 23, 2003
PATHWAY STM-10 PELVIC FLOOR STIMULATOR
K030039 · KPI
The Prometheus Group
Gastroenterology & Urology · 137d
Cleared May 23, 2003
AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)
K030230 · DXN
Avita Corporation
Cardiovascular · 121d
Cleared May 23, 2003
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
K030398 · DQR
Cardiacassist, Inc.
Cardiovascular · 106d
Cleared May 23, 2003
GAMBRO POLYFLUX, MODEL 140H, 170H, 210H
K030592 · KDI
Gambro Renal Care Products
Gastroenterology & Urology · 87d
Cleared May 23, 2003
DEFLECTING URETERAL ACCESS SHEATH
K030642 · FED
Applied Medical Resources Corp.
Gastroenterology & Urology · 84d
Cleared May 23, 2003
AMSURE FOLEY INSERTION TRAY
K030664 · FCM
Amsino International, Inc.
Gastroenterology & Urology · 81d
Cleared May 23, 2003
AMSURE URETHRAL CATHETERIZATION TRAY
K030712 · FCM
Amsino International, Inc.
Gastroenterology & Urology · 78d
Cleared May 23, 2003
FYRELINK VL
K030728 · LLZ
Mpacs, LLC
Radiology · 77d
Cleared May 23, 2003
NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204
K030827 · HAW
Orthosoft, Inc.
Neurology · 70d
Cleared May 23, 2003
ULTRAEKOGEL MODELS EK 2000 & EK 2001
K030889 · MUI
Inmed Ltda.
Radiology · 63d