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
57553–57576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 2008
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
K072753 · HIF
Rg Medical USA
Obstetrics & Gynecology · 120d
Cleared Jan 25, 2008
AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE
K072754 · EFB
Axenic Dental, Inc.
Dental · 120d
Cleared Jan 25, 2008
G-TRAINER MEDICAL
K072887 · BXB
Alter-G, Inc.
Physical Medicine · 107d
Cleared Jan 25, 2008
SAFESTEP MAX POWER-INJECTABLE INFUSION SET
K073050 · FPA
Specialized Health Products...
General Hospital · 88d
Cleared Jan 25, 2008
MODIFICATION TO AVEA VENTILATOR
K073069 · CBK
Viasys Respiratory Care, Inc.
Anesthesiology · 87d
Cleared Jan 25, 2008
KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR
K073257 · FMI
Kawasumi Laboratories, Inc.
General Hospital · 67d
Cleared Jan 25, 2008
ORTHO ANCHOR SCREWS
K073461 · OAT
Mis Implants Technologies , Ltd.
Dental · 46d
Cleared Jan 25, 2008
MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
K073625 · DPS
Ge Healthcare Systems Information...
Cardiovascular · 30d
Cleared Jan 25, 2008
BENGAL STACKABLE CAGE SYSTEM
K073649 · MQP
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Jan 25, 2008
OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
K073656 · MUD
Hypermed, Inc.
Cardiovascular · 30d
Cleared Jan 25, 2008
ALGO 5 NEWBORN HEARING SCREENER
K073665 · GWJ
Natus Medical, Inc.
Neurology · 30d
Cleared Jan 25, 2008
KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE...
K073670 · MQB
Orex Computed Radiography, Ltd.
Radiology · 29d
Cleared Jan 25, 2008
VERIFY CHALLENGE PACKS - VERSION 2
K073683 · JOJ
STERIS Corporation
General Hospital · 28d
Cleared Jan 24, 2008
IMPLASA-HOECHST GMBH IMPLANTS
K071240 · DZE
Implasa-Hoechst GmbH
Dental · 266d
Cleared Jan 24, 2008
CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
K072166 · NDY
The Binding Site
Chemistry · 171d
Cleared Jan 24, 2008
LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500
K072596 · MKJ
Amco International Manufacturing &...
Cardiovascular · 132d
Cleared Jan 24, 2008
3VISEON/SURGERY
K072653 · LLZ
3Mensio Medical Imaging BV
Radiology · 126d
Cleared Jan 24, 2008
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K072777 · LPL
Ciba Vision Corporation
Ophthalmic · 118d
Cleared Jan 24, 2008
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
K072779 · GEX
Biolitec, Inc.
General & Plastic Surgery · 118d
Cleared Jan 24, 2008
MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
K072806 · HAW
Mako Surgical Corp.
Neurology · 115d
Cleared Jan 24, 2008
P-NAIN SYSTEM
K072833 · GEX
Jeisys Medical, Inc.
General & Plastic Surgery · 113d
Cleared Jan 24, 2008
DSS
K072969 · NQP
Paradigm Spine, LLC
Orthopedic · 94d
Cleared Jan 24, 2008
SPERMCHECK VASECTOMY
K073039 · POV
Princeton BioMeditech Corp.
Hematology · 87d
Cleared Jan 24, 2008
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
K073080 · JJY
Bio-Rad Laboratories
Chemistry · 85d