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
72769–72792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2003
SMARTXIDE
K031224 · GEX
Cynosure, Inc.
General & Plastic Surgery · 22d
Cleared May 09, 2003
QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
K031289 · ITI
Sunrise Medical, Inc.
Physical Medicine · 16d
Cleared May 09, 2003
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K031293 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 16d
Cleared May 09, 2003
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
K031347 · ODG
Olympus Optical Co., Ltd.
Radiology · 10d
Cleared May 09, 2003
TRANSVAGINAL DOPPLER PROBE
K031358 · ITX
Vascular Control Systems, Inc.
Radiology · 9d
Cleared May 08, 2003
HEADFIX
K030439 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 86d
Cleared May 08, 2003
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344,...
K030573 · JKA
Bd Vacutainer Systems Preanalyical...
Chemistry · 73d
Cleared May 08, 2003
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
K031056 · MOS
Usa Instruments, Inc.
Radiology · 35d
Cleared May 08, 2003
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
K031089 · MOS
W.L. Gore & Associates, Inc.
Radiology · 31d
Cleared May 07, 2003
CO2 CLIP
K023820 · CCK
Bregas AB
Anesthesiology · 173d
Cleared May 07, 2003
ARTEGRAL AND POLYSTAR SELECTION
K030588 · ELM
Merz Dental GmbH
Dental · 71d
Cleared May 07, 2003
PD CASTA-H
K030632 · EJH
Mountain Medico, Inc.
Dental · 68d
Cleared May 06, 2003
SURGICAL SIMPLEX P WITH TOBRAMYCIN
K014199 · LOD
Howmedica Osteonics Corp.
Orthopedic · 501d
Cleared May 06, 2003
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
K022062 · MOD
Impact Instrumentation, Inc.
Anesthesiology · 315d
Cleared May 06, 2003
READI-LOAD SYSTEM, MODEL PSS 1820RL
K022389 · KXK
Worldwide Medical Technologies, LLC
Radiology · 287d
Cleared May 06, 2003
PEDIATRIC CENTRAL VENOUS CATHETER KIT
K023253 · FOZ
B.Braun Medical, Inc.
General Hospital · 218d
Cleared May 06, 2003
KALAZAR DETECT
K023483 · LOO
Inbios Intl., Inc.
Microbiology · 201d
Cleared May 06, 2003
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
K023615 · MSF
Gambro Renal Products
Gastroenterology & Urology · 190d
Cleared May 06, 2003
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF...
K023648 · LDJ
Sun Biomedical Laboratories, Inc.
Toxicology · 188d
Cleared May 06, 2003
ARAMIS II DERMATOLOGICAL LASER
K023734 · GEX
Quantel Medical
General & Plastic Surgery · 180d
Cleared May 06, 2003
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER
K023759 · DQD
Sonomedica
Cardiovascular · 179d
Cleared May 06, 2003
CT COLONOGRAPHY
K023943 · JAK
Ge Medical Systems, Inc.
Radiology · 161d
Cleared May 06, 2003
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
K030450 · JAK
J. Morita USA, Inc.
Radiology · 84d
Cleared May 06, 2003
LAC-MAC LIMITED INNERBLOC O.R. GOWN
K030536 · FYA
Lac Mac, Ltd.
General Hospital · 75d