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
80641–80664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2001
DIAMOND ALOE VERA, STERILE
K002666 · MGQ
Medi-Tech Intl. Corp.
General & Plastic Surgery · 186d
Cleared Feb 27, 2001
PARE ENDOSCOPIC SUTURING SYSTEM
K003102 · OCW
Pare Surgical, Inc.
Gastroenterology & Urology · 146d
Cleared Feb 27, 2001
MEDIVISION IGS SYSTEM
K003699 · HAW
Medivision (U.S.A.), Inc.
Neurology · 88d
Cleared Feb 27, 2001
SMF RESORBABLE MESHES AND SHEETS
K003786 · JEY
Synthes (Usa)
Dental · 81d
Cleared Feb 27, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003868 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 75d
Cleared Feb 27, 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K003946 · MOS
GE Medical Systems
Radiology · 68d
Cleared Feb 27, 2001
ENGPLUS
K010059 · GWN
Western Systems Research, Inc.
Neurology · 50d
Cleared Feb 27, 2001
PALFIQUE ESTELITE LV CLEAR
K010267 · EBF
Tokuyama America, Inc.
Dental · 29d
Cleared Feb 27, 2001
DUO-DENT DENTAL IMPLANT
K010386 · DZE
Duo-Dent Dental Implant Systems, LLC
Dental · 19d
Cleared Feb 27, 2001
MODEL THERMO TEK QUICKCARE
K010502 · FLL
Saat , Ltd.
General Hospital · 6d
Cleared Feb 23, 2001
MAEDA NEW NEEDLE DISPOSABLE
K000581 · MQX
Maeda Toyokichi Shoten
General Hospital · 367d
Cleared Feb 23, 2001
EASE-A-CULT
K002756 · KHE
Diagnostica, Inc.
Hematology · 171d
Cleared Feb 23, 2001
ORTHOPILOT
K003347 · HAW
Kinamed, Inc.
Neurology · 121d
Cleared Feb 23, 2001
FREEDLAND TENSION SYSTEM
K003648 · MBI
Etzem Technologies, Inc.
Orthopedic · 88d
Cleared Feb 23, 2001
TRITON HIP SYSTEM
K003649 · LWJ
Hayes Medical, Inc.
Orthopedic · 88d
Cleared Feb 23, 2001
FADASSI MEDICAL FM-1 NO BLENDER
K003665 · MRO
Fadasis Medical, Inc.
Anesthesiology · 87d
Cleared Feb 23, 2001
PERCUSSIVENEB, MODEL PN-2001
K003684 · NHJ
Vortran Medical Technology 1, Inc.
Anesthesiology · 86d
Cleared Feb 23, 2001
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
K003749 · FYC
Banta Healthcare
General Hospital · 81d
Cleared Feb 23, 2001
MICROTARGETING DRIVE SYSTEM
K003776 · HAW
FHC, Inc.
Neurology · 78d
Cleared Feb 23, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003834 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Feb 23, 2001
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
K010021 · FOZ
Medical Components, Inc.
General Hospital · 51d
Cleared Feb 23, 2001
ENA SCREEN EIA KIT
K010148 · LLL
The Binding Site, Ltd.
Immunology · 37d
Cleared Feb 23, 2001
STERILE POWDERED LATEX SURGEON GLOVES
K010198 · KGO
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 32d
Cleared Feb 23, 2001
CD HORIZON SPINAL SYSTEM
K010249 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d