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
44881–44904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2012
BIOBOLT
K120540 · MAI
Arthrex, Inc.
Orthopedic · 26d
Cleared Mar 19, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K110536 · LYZ
Zibo Tengyue Plastic Products Co., Ltd.
General Hospital · 388d
Cleared Mar 19, 2012
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
K112078 · KIF
Maruchi
Dental · 242d
Cleared Mar 19, 2012
CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
K112268 · KNT
Codan US Corp.
Gastroenterology & Urology · 224d
Cleared Mar 19, 2012
HIVOX BIOTEK INC.
K112392 · NUH
Hivox Biotek, Inc.
Neurology · 214d
Cleared Mar 19, 2012
METHA HIP SYSTEM
K112682 · LZO
Aesculap Implant Systems, LLC
Orthopedic · 186d
Cleared Mar 19, 2012
CLEARCORRECT SYSTEM
K113618 · NXC
Clearcorrect, Inc.
Dental · 103d
Cleared Mar 19, 2012
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K113808 · LJS
C.R. Bard, Inc.
General Hospital · 87d
Cleared Mar 19, 2012
PLEURX PERITONEAL CATHETER SYSTEM
K113854 · PNG
Care Fusion
Gastroenterology & Urology · 81d
Cleared Mar 19, 2012
ABL90 FLEX
K120197 · CHL
Radiometer Medical Aps
Chemistry · 56d
Cleared Mar 19, 2012
FILTEK BULK FILL FLOWABLE RESTORATIVE
K120453 · EBF
3M Espe Dental Products
Dental · 34d
Cleared Mar 19, 2012
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
K120544 · DRF
St Jude Medical
Cardiovascular · 25d
Cleared Mar 19, 2012
SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35
K120557 · OVD
Biomet Spine & Bone Healing Technologies
Orthopedic · 24d
Cleared Mar 16, 2012
UNIVERSAL MAXILLARY MOLAR
K110337 · DZE
Oco Biomedical
Dental · 406d
Cleared Mar 16, 2012
ENDO-EXPRESS (R) HANDPIECE
K111541 · EGS
Essential Dental Systems, Inc.
Dental · 288d
Cleared Mar 16, 2012
FEMTO LDV
K112154 · HQF
Sie Ag,Surgical Instument Engineering
Ophthalmic · 233d
Cleared Mar 16, 2012
NUVASIVE NVM5 SYSTEM
K112718 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 179d
Cleared Mar 16, 2012
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
K113239 · DXN
Health & Life Co., Ltd.
Cardiovascular · 135d
Cleared Mar 16, 2012
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA...
K113320 · MEH
Exactech, Inc.
Orthopedic · 127d
Cleared Mar 16, 2012
RNARETAIN
K113420 · OZF
Asuragen, Inc.
Pathology · 119d
Cleared Mar 16, 2012
1.5T GEM FLEX COIL
K113474 · MOS
Neocoil, LLC
Radiology · 115d
Cleared Mar 16, 2012
HORIZON CARDIOLOGY ECG MANAGEMENT
K113515 · DQK
Mckesson Israel , Ltd.
Cardiovascular · 109d
Cleared Mar 16, 2012
BD BACTEC Plus Aerobic/F Culture Vials (plastic)
K113558 · MDB
Becton, Dickinson and Company
Microbiology · 106d
Cleared Mar 16, 2012
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
K113763 · GAW
Nobles Medical Technologies Ii, Inc.
General & Plastic Surgery · 86d