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
63337–63360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2006
N ANTISERA TO HUMAN CERULOPLASMIN
K053074 · DDB
Dade Behring, Inc.
Immunology · 135d
Cleared Mar 16, 2006
N ANTISERA TO HUMAN TRANSFERRIN
K053075 · DDG
Dade Behring, Inc.
Immunology · 135d
Cleared Mar 16, 2006
ALLOFIX ANCHOR
K053339 · GAT
Musculoskeletal Transplant Foundation
General & Plastic Surgery · 105d
Cleared Mar 16, 2006
ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM
K053431 · DQY
Medtronic, Ireland
Cardiovascular · 97d
Cleared Mar 16, 2006
MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS
K053477 · DQA
Masimo Corporation
Anesthesiology · 92d
Cleared Mar 16, 2006
EQUIPMENT SLUSH DRAPE
K053495 · KKX
Advance Medical Designs, Inc.
General Hospital · 91d
Cleared Mar 16, 2006
DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
K053536 · KWA
Zimmer GmbH
Orthopedic · 87d
Cleared Mar 16, 2006
MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
K053560 · FAJ
Vision-Sciences, Inc.
Gastroenterology & Urology · 85d
Cleared Mar 16, 2006
BREAS VIVO 40 SYSTEM
K053607 · MNT
Breas Medical AB
Anesthesiology · 79d
Cleared Mar 16, 2006
CELLTRACKS ANALYZER II
K060110 · NQI
Immunicon Corp.
Pathology · 58d
Cleared Mar 16, 2006
SONIC PALPOMETER
K060125 · IKE
Palpometer Systems, Inc.
Physical Medicine · 57d
Cleared Mar 16, 2006
HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
K060127 · KRR
Arthrosurface, Inc.
Orthopedic · 57d
Cleared Mar 16, 2006
SPINAL USA CEMENT RESTRICTOR SYSTEM
K060132 · JDK
Spinal USA
Orthopedic · 57d
Cleared Mar 16, 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
K060137 · MQB
Eastman Kodak Company
Radiology · 56d
Cleared Mar 16, 2006
ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
K060216 · GEX
Energist, Ltd.
General & Plastic Surgery · 48d
Cleared Mar 16, 2006
BONEGEN - TR
K060285 · LYC
Bio-Lok Intl., Inc.
Dental · 41d
Cleared Mar 16, 2006
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER
K060440 · LMC
Codonics, Inc.
Radiology · 23d
Cleared Mar 16, 2006
ERBE VIO ESU, MODEL VIO 300 D
K060484 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 20d
Cleared Mar 16, 2006
INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR
K060582 · IOR
Invacare Corporation
Physical Medicine · 9d
Cleared Mar 16, 2006
DENFIL FLOW
K060637 · EBF
Vericom Co., Ltd.
Dental · 6d
Cleared Mar 15, 2006
CRYOFLOW 700, CRYOFLOW 1000
K052310 · GEX
Uniphy Elektromedizin GmbH & Co. KG
General & Plastic Surgery · 203d
Cleared Mar 15, 2006
MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
K052555 · DTQ
Rand S.R.L.
Cardiovascular · 180d
Cleared Mar 15, 2006
COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
K053290 · GEI
Valleylab
General & Plastic Surgery · 110d
Cleared Mar 15, 2006
MYOTRAC INFINITI ELECTRICAL STIMULATOR
K053434 · KPI
Thought Technology , Ltd.
Gastroenterology & Urology · 96d