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
78337–78360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2001
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
K013059 · GAQ
Stony Brook Surgical Innovations, Inc.
General & Plastic Surgery · 41d
Cleared Oct 22, 2001
BIOSCANNER PLUS
K013173 · CHH
Polymer Technology Systems, Inc.
Chemistry · 28d
Cleared Oct 22, 2001
STATUSBLUE
K013237 · ELW
Dmg USA, Inc.
Dental · 24d
Cleared Oct 22, 2001
ASTRALIS 7, MODEL 557545
K013277 · EBZ
Ivoclar Vivadent, Inc.
Dental · 20d
Cleared Oct 19, 2001
RIWO SYSTEM TRAYS
K012309 · FEB
Richard Wolf Medical Instruments Corp.
General Hospital · 88d
Cleared Oct 19, 2001
POWERPRO BATTERY SYSTEM
K012320 · HAB
Linvatec Corp.
General & Plastic Surgery · 88d
Cleared Oct 19, 2001
AML HIP PROSTHESIS
K012364 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Oct 19, 2001
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
K012510 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 74d
Cleared Oct 19, 2001
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016 · LZA
Tillotson Healthcare Corp.
General Hospital · 42d
Cleared Oct 19, 2001
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6...
K013135 · DHB
Diagnostic Products Corp.
Immunology · 30d
Cleared Oct 19, 2001
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
MARK II/MARK III MANOMETRIC PERFUSION PUMP
K013154 · FFX
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K013156 · MSX
Data Critical Corp.
Cardiovascular · 28d
Cleared Oct 19, 2001
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH...
K013162 · KNT
Medcomp
Gastroenterology & Urology · 28d
Cleared Oct 19, 2001
ASTRALIS 10, MODELS # 559588, 561859
K013275 · EBZ
Ivoclar Vivadent, Inc.
Dental · 18d
Cleared Oct 19, 2001
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K013356 · FCG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 9d
Cleared Oct 18, 2001
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
K002132 · MUJ
Intelligent Instruments Pvt. , Ltd.
Radiology · 461d
Cleared Oct 18, 2001
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
K003857 · JOW
Sterilmed, Inc.
Cardiovascular · 309d
Cleared Oct 18, 2001
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
K012409 · NHB
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 80d
Cleared Oct 18, 2001
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
K012424 · JAA
Shimadzu Corp.
Radiology · 80d
Cleared Oct 18, 2001
WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
K012522 · ITX
National Therapy Products, Inc.
Radiology · 73d
Cleared Oct 18, 2001
PROSAFE SAFETY SYRINGE
K012726 · MEG
Hou-Se Medical, Inc.
General Hospital · 64d
Cleared Oct 18, 2001
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
K012961 · JDI
Sulzer Orthopedics, Inc.
Orthopedic · 44d