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

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175,820 results
44425–44448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2012
SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM...
K120149 · FLE
Sakura Seiki Co., Ltd.
General Hospital · 111d
Cleared May 08, 2012
CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
K120298 · DQX
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 98d
Cleared May 08, 2012
LIFESTYLES ZERO LUBRICATED LATEX CONDOM
K120394 · HIS
Ansell Heathcare Products, LLC
Obstetrics & Gynecology · 90d
Cleared May 08, 2012
RELIANCE CERVICAL IBF SYSTEM
K120396 · ODP
Reliance Medical Systems, LLC
Orthopedic · 90d
Cleared May 08, 2012
GLOW BY ENDYMED
K120513 · OUH
Endymed Medical, Ltd.
General & Plastic Surgery · 77d
Cleared May 08, 2012
SYNAPSE 3D BRAIN PERFUSION
K120637 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared May 08, 2012
LATEX EXAMINATION GLOVES (POWDERED)
K120693 · LYY
Top Calibre Sdn Bhd
General Hospital · 62d
Cleared May 08, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL...
K120717 · HRS
Synthes (Usa)
Orthopedic · 61d
Cleared May 08, 2012
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS,...
K120761 · DJG
Lin-Zhi International, Inc.
Toxicology · 56d
Cleared May 08, 2012
INFU BOX TYPE 0412A
K120860 · LGZ
Medical Rescue Equipment Holding AS
General Hospital · 47d
Cleared May 08, 2012
SOMATOM DEFINITION FLASH
K121072 · JAK
Siemens Medical Systems, Inc.
Radiology · 29d
Cleared May 08, 2012
PLATEAU SPACER SYSTEM
K121116 · MAX
Life Spine
Orthopedic · 26d
Cleared May 08, 2012
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
K121166 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared May 08, 2012
TERUMO PALL AL20X ARTERIAL FILTER
K121209 · DTM
Terumo Cardiovascular Systems...
Cardiovascular · 18d
Cleared May 07, 2012
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
K112790 · LPS
Axis-Shield Diagnostics, Ltd.
Chemistry · 224d
Cleared May 07, 2012
GEN_2 MECHANICAL WHEELCHAIR
K113713 · IOR
Free Wheelchair Mission
Physical Medicine · 140d
Cleared May 07, 2012
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW,...
K113732 · JAK
Brainlab AG
Radiology · 140d
Cleared May 07, 2012
APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
K120106 · MUH
Apixia, Inc.
Radiology · 115d
Cleared May 07, 2012
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
K120550 · DQK
Biosense Webster, Inc.
Cardiovascular · 74d
Cleared May 07, 2012
PIONEER LATERAL PLATE SYSTEM
K120724 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 59d
Cleared May 04, 2012
QUANTUM DENTAL IMPLANT SYSTEM
K112279 · DZE
Quantum Bioengineering, Ltd.
Dental · 269d
Cleared May 04, 2012
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE...
K112549 · FRO
Covalontechnologies, Inc.
General & Plastic Surgery · 246d
Cleared May 04, 2012
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
K112665 · EKX
J. Morita USA, Inc.
Dental · 234d
Cleared May 04, 2012
STERILCONTAINER SYSTEM
K112671 · KCT
Aesculap, Ltd.
General Hospital · 233d