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
64825–64848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2005
HIPAX MEDICAL IMAGING SOFTWARE
K052411 · LLZ
Steinhart Medizinsysteme GmbH
Radiology · 23d
Cleared Sep 21, 2005
GE LOGIQ 7 ULTRASOUND BT05
K052441 · IYN
General Electric Co.
Radiology · 15d
Cleared Sep 21, 2005
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
K052447 · JAK
Analogic Corp.
Radiology · 14d
Cleared Sep 21, 2005
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
K052452 · EOB
Olympus Medical Systems Corporation
Ear, Nose, Throat · 15d
Cleared Sep 21, 2005
POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE
K052460 · LLZ
Ramsoft, Inc.
Radiology · 14d
Cleared Sep 20, 2005
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
K051259 · GEX
Theralight, Inc.
General & Plastic Surgery · 127d
Cleared Sep 20, 2005
NON-STERILE SURGICAL MASK
K051291 · FXX
A.R. Medicom, Inc.
General Hospital · 125d
Cleared Sep 20, 2005
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A
K051357 · GWF
Digitimer , Ltd.
Neurology · 119d
Cleared Sep 20, 2005
MAYFIELD INFINITY SKULL CLAMP
K051440 · HBL
Integra Lifesciences Corp.
Neurology · 110d
Cleared Sep 20, 2005
BLUEPHASE 16I
K051782 · EBZ
Ivoclar Vivadent, Inc.
Dental · 81d
Cleared Sep 20, 2005
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · FLL
Ge Healthcare
General Hospital · 71d
Cleared Sep 20, 2005
VENAFLO II VASCULAR GRAFT
K052282 · DSY
Bard Peripheral Vascular, Inc.
Cardiovascular · 29d
Cleared Sep 20, 2005
MAXIMUS 3.0 AND OS IMPLANTS
K052419 · DZE
BioHorizons Implant Systems, Inc.
Dental · 18d
Cleared Sep 20, 2005
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
K052444 · JEY
Inion , Ltd.
Dental · 14d
Cleared Sep 19, 2005
O.A.S.I. SYSTEM
K051552 · DZE
Lancer Orthodontics, Inc.
Dental · 98d
Cleared Sep 19, 2005
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
K051750 · LBH
Ultradent Products, Inc.
Dental · 82d
Cleared Sep 16, 2005
BIOBANDS
K051397 · MVV
Biobands Distributors, Inc.
Neurology · 112d
Cleared Sep 16, 2005
NEURODRIVE SYSTEM
K051830 · GZL
Alpha Omega , Ltd.
Neurology · 72d
Cleared Sep 16, 2005
MBCP
K051885 · LYC
Biomatlante
Dental · 66d
Cleared Sep 16, 2005
IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7
K052008 · ITI
Imc-Heart Way LLC
Physical Medicine · 53d
Cleared Sep 16, 2005
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
K052412 · OWB
Ge Healthcare
Radiology · 14d
Cleared Sep 15, 2005
SCHUCO MIST AND SCHUCO DELUXE MIST
K051260 · CAF
Allied Healthcare Products, Inc.
Anesthesiology · 123d
Cleared Sep 15, 2005
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
K051313 · MNR
Salter Labs
Anesthesiology · 119d
Cleared Sep 15, 2005
3I OSSEOTITE DENTAL IMPLANTS
K051461 · DZE
Implant Innovations, Inc.
Dental · 104d