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
64729–64752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2005
POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
K052273 · LYY
Pt Mahakarya Inti Buana
General Hospital · 39d
Cleared Sep 30, 2005
COLOR CORONIS 2MP-21 AND MFCD 2321
K052352 · LLZ
Barcoview
Radiology · 32d
Cleared Sep 30, 2005
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
K052464 · LCP
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Sep 30, 2005
E-2320 PA S
K052529 · LLZ
Barcoview
Radiology · 16d
Cleared Sep 30, 2005
DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE
K052551 · FMF
Devon Safety Products, Inc.
General Hospital · 14d
Cleared Sep 29, 2005
CARTO RMT EP NAVIGATION SYSTEM
K042681 · DQK
Biosense Webster, Inc.
Cardiovascular · 365d
Cleared Sep 29, 2005
REFSTAR RMT EXTERNAL REFERENCE PATCH
K042998 · DRF
Biosense Webster, Inc.
Cardiovascular · 332d
Cleared Sep 29, 2005
LINEAGE HA ACETABULAR SHELLS
K043099 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 324d
Cleared Sep 29, 2005
ADVANTA T-GRAFT
K051332 · DSY
Atrium Medical Corp.
Cardiovascular · 129d
Cleared Sep 29, 2005
RINGLOC BI-POLAR ACETABULAR COMPONENT
K051569 · JDI
Biomet, Inc.
Orthopedic · 107d
Cleared Sep 29, 2005
MERRIES UNI-OSTEO, MODEL CS30250-CS10102
K051698 · MQV
Merries International, Inc.
Orthopedic · 97d
Cleared Sep 29, 2005
VICRYL * MESH BAG
K051701 · FTL
Ethicon, Inc.
General & Plastic Surgery · 97d
Cleared Sep 29, 2005
COPELAND EAS HUMERAL RESURFACING HEADS
K051843 · HSD
Biomet, Inc.
Orthopedic · 84d
Cleared Sep 29, 2005
OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
K052027 · CGZ
Osmetech, Inc.
Chemistry · 64d
Cleared Sep 29, 2005
NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
K052083 · DRF
Biosense Webster, Inc.
Cardiovascular · 58d
Cleared Sep 29, 2005
VITEK 2 GRAM NEGATIVE TIGECYCLINE
K052311 · LON
bioMerieux, Inc.
Microbiology · 36d
Cleared Sep 29, 2005
POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS
K052415 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 27d
Cleared Sep 29, 2005
SITE-RITE 5 ULTRASOUND SYSTEM
K052517 · ITX
C.R. Bard, Inc.
Radiology · 15d
Cleared Sep 28, 2005
CAREVENT ATV+ AND CAREVENT MRI
K051469 · BTL
O-Two Medical Technologies, Inc.
Anesthesiology · 117d
Cleared Sep 28, 2005
THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777
K051861 · INK
Savion Industries, Ltd.
Physical Medicine · 83d
Cleared Sep 28, 2005
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
K051940 · MXK
Sis Ltd., Surgical Instrument Systems
Ophthalmic · 72d
Cleared Sep 28, 2005
CERAMENT BONE VOID FILLER
K051951 · MQV
Bonesupport AB
Orthopedic · 72d
Cleared Sep 28, 2005
CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR
K052009 · GEI
Conmed Corporation
General & Plastic Surgery · 65d
Cleared Sep 28, 2005
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS
K052131 · KWP
Depuy Spine, Inc.
Orthopedic · 54d