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
55465–55488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2008
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
K081893 · HWC
Arthrocare Corp.
Orthopedic · 90d
Cleared Oct 01, 2008
NEOMED POLYURETHANE FEEDING TUBE
K082238 · FPD
Neomed, Inc.
Gastroenterology & Urology · 55d
Cleared Oct 01, 2008
MAGNETOM C!
K082331 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Oct 01, 2008
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS...
K082510 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 33d
Cleared Oct 01, 2008
MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER
K082707 · ILY
Medx Electronics, Inc.
Physical Medicine · 15d
Cleared Oct 01, 2008
MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE...
K082757 · JEY
Bioplate, Inc.
Dental · 12d
Cleared Oct 01, 2008
STRAUMANN WN CARES TITANIUM ABUTMENT
K082764 · NHA
Institut Straumann AG
Dental · 9d
Cleared Sep 30, 2008
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
K080570 · NXD
Centers For Disease Control and...
Microbiology · 214d
Cleared Sep 30, 2008
COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
K081425 · LJT
Cook Vascular, Inc.
General Hospital · 132d
Cleared Sep 30, 2008
ENCORE SHOULDER REVISION GLENOID
K081448 · MBF
Encore Medical, L.P.
Orthopedic · 130d
Cleared Sep 30, 2008
POWDER-FREE VINYL EXAMINATION GLOVES
K081658 · LYZ
Jiangsu Alfa Glove Co., Ltd.
General Hospital · 110d
Cleared Sep 30, 2008
AVANTE Z ZIRCONIA (AS)3 BLOCKS
K081749 · EIH
Pentron Ceramics, Inc.
Dental · 103d
Cleared Sep 30, 2008
COLLIEVA
K081782 · KGN
Innocoll Pharmaceuticals
General & Plastic Surgery · 99d
Cleared Sep 30, 2008
SECURACATH CATHETER, MODEL SPK01
K082047 · OKC
Interrad Medical, Inc.
General Hospital · 74d
Cleared Sep 30, 2008
CIVASTRING PD-103
K082159 · KXK
Civatech Oncology, Inc.
Radiology · 61d
Cleared Sep 30, 2008
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR...
K082364 · NFJ
Topcon Corp.
Ophthalmic · 43d
Cleared Sep 30, 2008
DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
K082444 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 36d
Cleared Sep 30, 2008
APPLIED BIOSYSTEMS 7500 FAST DX
K082562 · NSU
Applied Biosystems, Inc.
Microbiology · 26d
Cleared Sep 30, 2008
AVAULTA SUPPORT SYSTEM
K082571 · OTP
C.R. Bard, Inc.
Obstetrics & Gynecology · 25d
Cleared Sep 30, 2008
MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
K082656 · IYN
Fukuda Denshi USA, Inc.
Radiology · 18d
Cleared Sep 29, 2008
AED BIPOLAR FORCEPS, MODEL 13-1646
K081553 · GEI
National Advanced Endoscopy Devices,...
General & Plastic Surgery · 118d
Cleared Sep 29, 2008
VENTRIO HERNIA PATCH
K081777 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 98d
Cleared Sep 29, 2008
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
K081865 · LPL
CooperVision, Inc.
Ophthalmic · 90d
Cleared Sep 29, 2008
UNIVERSAL ELECTRODES
K081871 · GXY
Neurometrix, Inc.
Neurology · 90d