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
42457–42480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2012
INVENDO C25 COLONOSCOPY SYSTEM
K121582 · FDF
Invendo Medical Gbmh
Gastroenterology & Urology · 204d
Cleared Dec 20, 2012
REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER
K121913 · OWQ
Stryker Sustainability Solutions, Inc.
Cardiovascular · 171d
Cleared Dec 20, 2012
HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM...
K121998 · FYA
Changzhou Holymed Products Co., Ltd.
General Hospital · 164d
Cleared Dec 20, 2012
DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
K122075 · CCK
Intersurgical, Inc.
Anesthesiology · 157d
Cleared Dec 20, 2012
EXTERNAL FIXATOR SYSTEM
K122208 · NDK
Christopher D. Endara
Orthopedic · 148d
Cleared Dec 20, 2012
NOVA ONE BLOOD GLUCOSE MONITOR
K122435 · LFR
Nova Biomedical Corporation
Chemistry · 132d
Cleared Dec 20, 2012
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS,...
K122575 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 119d
Cleared Dec 20, 2012
FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF...
K122658 · PCF
Femasys, Inc.
Obstetrics & Gynecology · 111d
Cleared Dec 20, 2012
OXICARE FINGERTIP PULSE OXIMETER
K122927 · DQA
Delbio Incorporated
Anesthesiology · 87d
Cleared Dec 20, 2012
GKS PRIME FLEX CR TOTAL KNEE SYSTEM
K122975 · JWH
Permedica
Orthopedic · 85d
Cleared Dec 20, 2012
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K122991 · JWH
Conformis, Inc.
Orthopedic · 85d
Cleared Dec 20, 2012
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
K123046 · DFC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d
Cleared Dec 20, 2012
FUTURO (TM) TRAVEL KNEE-HIGHS
K123085 · DWL
3M Company
General Hospital · 80d
Cleared Dec 20, 2012
STABILINK MIS SPINAL FIXATION SYSTEM
K123093 · KWP
Southern Spine, LLC
Orthopedic · 79d
Cleared Dec 20, 2012
Q-PLUS T+ IPL LASER SYSTEM
K123168 · GEX
Quanta System Spa
General & Plastic Surgery · 72d
Cleared Dec 20, 2012
g.HIamp
K123255 · GWL
G.Tec Medical Engineering GmbH
Neurology · 63d
Cleared Dec 20, 2012
TRUEBEAM
K123291 · IYE
Varian Medical Systems, Inc.
Radiology · 59d
Cleared Dec 20, 2012
HEALTHVIEW ECG MANAGER
K123466 · DQK
Lumedx
Cardiovascular · 41d
Cleared Dec 20, 2012
AEROPILOT
K123499 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 37d
Cleared Dec 20, 2012
SCENIUM
K123528 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Dec 20, 2012
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
K123530 · LLZ
Hologic, Inc.
Radiology · 34d
Cleared Dec 20, 2012
SYNGO, CT CARDIAC FUNCTION
K123585 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Dec 20, 2012
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF...
K123659 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Dec 19, 2012
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
K112644 · MQK
Lotus Bio, Ltd.
Obstetrics & Gynecology · 464d