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
79777–79800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2001
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K011474 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 17d
Cleared May 30, 2001
SCAPHIX, STAPLE, FIXATION, BONE
K003033 · JDR
Avanta Orthopaedics, Inc.
Orthopedic · 244d
Cleared May 30, 2001
REBSTOCK YASARGIL ANEURYSM CLIP
K003500 · HCH
Rebstock - Instrumente GmbH
Neurology · 198d
Cleared May 30, 2001
SYNTHES RESORABLE MESHES AND SHEETS
K003788 · HRS
Synthes (Usa)
Orthopedic · 173d
Cleared May 30, 2001
CONVERGENCE CERVICAL SPINAL SYSTEM
K010639 · KWQ
Spinal Innovations, LLC
Orthopedic · 86d
Cleared May 30, 2001
ENSIL FABRIC
K010675 · MDA
Gottfried Medical, Inc.
General & Plastic Surgery · 85d
Cleared May 30, 2001
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD,...
K010716 · FSY
Valmed Corp.
General & Plastic Surgery · 82d
Cleared May 30, 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared May 30, 2001
2.0/2.4 CANNULATED SCREW SYSTEM
K010783 · HWC
Osteomed Corp.
Orthopedic · 76d
Cleared May 30, 2001
PERC-D SPINEWAND
K010811 · HRX
Arthrocare Corp.
Orthopedic · 72d
Cleared May 30, 2001
MARK 9000 PHASED ARRAY SHOULDER COIL
K010946 · MOS
Usa Instruments, Inc.
Radiology · 62d
Cleared May 30, 2001
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
K011002 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 57d
Cleared May 30, 2001
FORTAFLEX SURGICAL SLING
K011027 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 55d
Cleared May 30, 2001
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
K011105 · GAL
Qrc Consulting
General & Plastic Surgery · 49d
Cleared May 30, 2001
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
K011111 · KPR
Modular X-Ray Devices
Radiology · 49d
Cleared May 30, 2001
EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM
K011252 · IYO
Hitachi Medical Corp.
Radiology · 36d
Cleared May 30, 2001
PROGNOST ES, MODEL 0302 0000
K011290 · IZF
Xmar Corp.
Radiology · 33d
Cleared May 30, 2001
ALPCO MILENIA ANTI-TG EIA
K011415 · JZO
American Laboratory Products Co., Ltd.
Immunology · 22d
Cleared May 29, 2001
VECTORSURGE 5, MODEL VS-500
K002058 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 327d
Cleared May 29, 2001
DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
K003630 · MVA
Danmar Products, Inc.
Neurology · 186d
Cleared May 29, 2001
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647 · DIS
Alfa Scientific Designs, Inc.
Toxicology · 183d
Cleared May 29, 2001
SCS CLOSED SCREW
K003733 · MNH
Ortho Tec, LLC
Orthopedic · 176d
Cleared May 29, 2001
SYNTHES SYNEX SPACER SYSTEM
K003836 · MQP
Synthes
Orthopedic · 168d
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
K003845 · LAF
Alfa Scientific Designs, Inc.
Toxicology · 168d