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

Filters: Cleared only ×
176,076 results
62233–62256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2006
STORM OPERATING KIT, MODEL 1-10-0
K061607 · HTY
Intelligent Orthopaedics, Ltd.
Orthopedic · 39d
Cleared Jul 18, 2006
KALIX II IMPLANT
K061765 · HWC
New Deal, S.A.
Orthopedic · 26d
Cleared Jul 18, 2006
NUVASIVE SPHERX II SYSTEM
K061778 · MNH
Nuvasive, Inc.
Orthopedic · 22d
Cleared Jul 18, 2006
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0...
K061792 · DIC
Dade Behring, Inc.
Toxicology · 22d
Cleared Jul 18, 2006
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
K061818 · JIT
Dade Behring, Inc.
Chemistry · 20d
Cleared Jul 18, 2006
MODIFICATION TO ALLOMATRIX CUSTOM
K061939 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 8d
Cleared Jul 17, 2006
COMPACT PLUS - EXTREME - PERFECT PLUS
K052574 · EIA
J.O. Suarez & Cia, Ltda
Dental · 301d
Cleared Jul 17, 2006
SURGICAL MESH SYSTEM
K053215 · FTL
Nuvasive, Inc.
General & Plastic Surgery · 242d
Cleared Jul 17, 2006
MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
K053624 · HRS
Medicon EG
Orthopedic · 201d
Cleared Jul 17, 2006
ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS
K060675 · DQA
Envitec-Wismar GmbH
Anesthesiology · 125d
Cleared Jul 17, 2006
VIRTUAL
K060891 · ELW
Ivoclar Vivadent, Inc.
Dental · 108d
Cleared Jul 17, 2006
GALILEO GOLD ASV
K061090 · CBK
Hamilton Medical AG
Anesthesiology · 90d
Cleared Jul 17, 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · KWL
Smith & Nephew, Inc.
Orthopedic · 75d
Cleared Jul 17, 2006
NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
K061553 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 42d
Cleared Jul 17, 2006
FRAGMENT PLATE SYSTEM
K061748 · KTT
Hand Innovations, LLC
Orthopedic · 26d
Cleared Jul 17, 2006
DEPUY AML HIP PROSTHESIS
K061833 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 18d
Cleared Jul 14, 2006
SCORPION ULTRASONIC SCALING INSERTS
K053578 · ELC
Scorpion
Dental · 204d
Cleared Jul 14, 2006
INVITRO MATURATION MEDIA
K053646 · MQL
Sage In-Vitro Fertilization, Inc.
Obstetrics & Gynecology · 196d
Cleared Jul 14, 2006
TYRX ANTIMICROBIAL MESH
K053656 · FTL
Tyrx Pharma, Inc.
General & Plastic Surgery · 196d
Cleared Jul 14, 2006
MASKMEDIC CONCEPT NASAL MASK
K060067 · BZD
Maskmedic
Anesthesiology · 186d
Cleared Jul 14, 2006
POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE
K060812 · LJT
C.R. Bard, Inc.
General Hospital · 112d
Cleared Jul 14, 2006
COLLAGEN NERVE WRAP
K060952 · JXI
Collagen Matrix, Inc.
Neurology · 99d
Cleared Jul 14, 2006
PDS PLUS ANTIBACTERIAL SUTURE
K061037 · NEW
Ethicon, Inc.
General & Plastic Surgery · 91d
Cleared Jul 14, 2006
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
K061050 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 88d