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

Filters: Cleared only ×
176,076 results
62929–62952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2006
MEDELA SWING BREAST PUMP
K053052 · HGX
Medela AG
Obstetrics & Gynecology · 183d
Cleared May 02, 2006
EAGLEVISION GELLANSERTS, MODEL REF 0040
K053333 · LZU
Eagle Vision, Inc.
Ophthalmic · 152d
Cleared May 02, 2006
SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL...
K060273 · BZD
Sleepnet Corporation
Anesthesiology · 89d
Cleared May 02, 2006
FIDIS DSDNA
K060380 · LSW
Biomedical Diagnostics (Bmd) SA
Immunology · 77d
Cleared May 02, 2006
CMA CEREBRAL TISSUE MONITORING SYSTEM
K060554 · GWM
Cma Microdialysis AB
Neurology · 62d
Cleared May 02, 2006
COSMAN CSK RF CANNULA
K060799 · GXI
Cosman Medical, Inc.
Neurology · 39d
Cleared May 02, 2006
G.USBAMP
K060803 · GWL
G.Tec Medical Engineering GmbH
Neurology · 39d
Cleared May 02, 2006
BIFIX QM
K060894 · EMA
Voco GmbH
Dental · 29d
Cleared May 02, 2006
HEMOSIL PT-FIBRINOGEN HS PLUS
K060931 · GJS
Instrumentation Laboratory CO
Hematology · 27d
Cleared May 02, 2006
PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
K061009 · EZN
Onset Medical Corporation
Gastroenterology & Urology · 20d
Cleared May 01, 2006
PYLO-PLUS
K052708 · LYR
Arj Medical, Inc.
Microbiology · 214d
Cleared May 01, 2006
TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
K060073 · LZA
Shen Wei (Usa), Inc.
General Hospital · 112d
Cleared May 01, 2006
PIEZOTOME
K060274 · DZI
Satelec
Dental · 88d
Cleared May 01, 2006
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0
K060633 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared May 01, 2006
NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT
K060728 · MQV
Novabone Products, LLC
Orthopedic · 45d
Cleared May 01, 2006
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE...
K060771 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 40d
Cleared May 01, 2006
SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED
K060784 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 40d
Cleared May 01, 2006
15-INCH (38CM) COLOR LCD MONITOR CDL1566A
K060961 · LLZ
Totoku Electric Co., Ltd.
Radiology · 24d
Cleared May 01, 2006
JETSTREAM WORKSPACE
K061029 · LLZ
Adac Laboratories
Radiology · 17d
Cleared Apr 28, 2006
POROUS TITANIUM ACETABULAR SHELLS
K052996 · LPH
Biomet Manufacturing Corp
Orthopedic · 185d
Cleared Apr 28, 2006
MICRUS GUIDE WIRE, WATUSI 0.014
K053265 · DQX
Micrus Endovascular Corporation
Cardiovascular · 157d
Cleared Apr 28, 2006
PRESEP OLIGON OXIMETRY CATHETERS
K060093 · DQE
Edwards Lifesciences, LLC
Cardiovascular · 106d
Cleared Apr 28, 2006
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
K060139 · DCK
Diagnostic Chemicals , Ltd.
Chemistry · 99d
Cleared Apr 28, 2006
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K060147 · LZA
Hongye Plastic Products Co., Ltd.
General Hospital · 99d