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
69793–69816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2004
FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
K040472 · GAT
Teleflex Medical
General & Plastic Surgery · 20d
Cleared Mar 15, 2004
COLTOLUX LED CURING LIGHT
K040551 · EBZ
Coltene/Whaledent, Inc.
Dental · 13d
Cleared Mar 12, 2004
INVACARE POLARIS EX CPAP, MODEL ISP3000
K031064 · BZD
Invacare Corp.
Anesthesiology · 344d
Cleared Mar 12, 2004
ENDOFLEX TRACHEAL TUBE
K031794 · BTR
Merlyn Associates, Inc.
Anesthesiology · 276d
Cleared Mar 12, 2004
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL...
K032936 · JIX
Stanbio Laboratory
Chemistry · 172d
Cleared Mar 12, 2004
RFS VACUUM GAUGE SCAVENGING CIRCUIT
K033503 · CBN
Accutron, Inc.
Anesthesiology · 128d
Cleared Mar 12, 2004
IMAGE MANAGEMENT SYSTEM
K033870 · HEX
Welch Allyn, Inc.
Obstetrics & Gynecology · 91d
Cleared Mar 12, 2004
SPECTRUM MODULAR SYSTEM
K033893 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Mar 12, 2004
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL...
K033919 · LPL
Ciba Vision Corporation
Ophthalmic · 85d
Cleared Mar 12, 2004
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
K033944 · LZO
Stelkast Company
Orthopedic · 84d
Cleared Mar 12, 2004
STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM
K040022 · HRS
Stryker Leibinger
Orthopedic · 65d
Cleared Mar 12, 2004
IMMUNICON CELLTRACKS AUTOPREP SYSTEM
K040077 · GKH
Immunicon Corp.
Hematology · 58d
Cleared Mar 12, 2004
TRIMED BEARING PLATE
K040112 · HRS
Tri-Med, Inc.
Orthopedic · 52d
Cleared Mar 12, 2004
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
K040295 · HET
Applied Medical Resources Corp.
Obstetrics & Gynecology · 32d
Cleared Mar 12, 2004
SINON POWER WHEELCHAIR, SN-P401
K040320 · ITI
Sinon Corporation
Physical Medicine · 32d
Cleared Mar 12, 2004
MODIFICATION TO ORIA TOP CLIP SYSTEM
K040346 · MNI
Ortho Tec, LLC
Orthopedic · 29d
Cleared Mar 12, 2004
RANDOX LIQUID CRP CONTROLS
K040351 · JJX
Randox Laboratories, Ltd.
Chemistry · 29d
Cleared Mar 12, 2004
EMU128S, MODEL EX-NW-128S
K040360 · GWQ
Excel Tech. , Ltd.
Neurology · 28d
Cleared Mar 12, 2004
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
K040447 · LQC
Boston Scientific Corp
Gastroenterology & Urology · 21d
Cleared Mar 11, 2004
POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
K033177 · HET
Gunter Bissinger Medizintechnik GmbH
Obstetrics & Gynecology · 162d
Cleared Mar 11, 2004
GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
K033351 · HRY
Global Orthopaedic Technology, USA, Inc.
Orthopedic · 143d
Cleared Mar 11, 2004
NAVIPRO KNEE SOFTWARE MODULE
K033668 · HAW
Kinamed, Inc.
Neurology · 111d
Cleared Mar 11, 2004
KAEN YIH UMBILICAL CORD CLAMP
K033846 · HFW
Kaen Yih Enterprise Co., Ltd.
Obstetrics & Gynecology · 91d
Cleared Mar 11, 2004
DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323,...
K033876 · DQA
Dolphin Medical, Inc.
Anesthesiology · 87d