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
71113–71136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2003
ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110
K030627 · DRF
C.R. Bard, Inc.
Cardiovascular · 238d
Cleared Oct 23, 2003
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · LZG
Medtronic Minimed
General Hospital · 100d
Cleared Oct 23, 2003
MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
K032530 · FGE
Guidant Corporation
Gastroenterology & Urology · 69d
Cleared Oct 23, 2003
BIOPSY BREAST COIL, MODEL BBC
K032576 · MOS
Mri Devices Corp.
Radiology · 64d
Cleared Oct 23, 2003
COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE
K032698 · GAM
Coapt Systems, Inc.
General & Plastic Surgery · 51d
Cleared Oct 23, 2003
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
K032820 · ODE
Ndo Surgical, Inc.
Gastroenterology & Urology · 43d
Cleared Oct 23, 2003
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K032930 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 31d
Cleared Oct 23, 2003
ELEKTA SYNERGY SYSTEM
K032996 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 28d
Cleared Oct 23, 2003
GE MARLIN ULTRASOUND
K033139 · IYN
General Electric Co.
Radiology · 23d
Cleared Oct 22, 2003
RAPHAEL
K022679 · CBK
Hamilton Medical AG
Anesthesiology · 436d
Cleared Oct 22, 2003
ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE
K023139 · KGO
Van Oostveen Medical B.V.
General Hospital · 397d
Cleared Oct 22, 2003
FERRIS POLYMEM SILVER WOUND DRESSING
K031307 · FRO
Ferris Mfg. Corp.
General & Plastic Surgery · 181d
Cleared Oct 22, 2003
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE...
K031329 · IMI
Dynatronics Corp.
Physical Medicine · 177d
Cleared Oct 22, 2003
CONKLUSION PEDICLE SCREW SYSTEM
K031455 · MNI
Signus Medical, LLC
Orthopedic · 168d
Cleared Oct 22, 2003
INTER-OS LIMB LENGTHENER
K031875 · KTT
Inter-Os Technologies
Orthopedic · 127d
Cleared Oct 22, 2003
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
K031952 · NOP
Focus Technologies, Inc.
Microbiology · 119d
Cleared Oct 22, 2003
WEST NILE VIRUS ELISA IGG, MODEL EL0300G
K031953 · NOP
Focus Technologies, Inc.
Microbiology · 119d
Cleared Oct 22, 2003
PARIEFIX
K032093 · GCJ
Sofradim Production
General & Plastic Surgery · 107d
Cleared Oct 22, 2003
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
K032374 · LZC
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 82d
Cleared Oct 22, 2003
MORALES PROTRACTION FACEMASK
K032392 · DZB
Ortosim, S.A. DE C.V.
Dental · 79d
Cleared Oct 22, 2003
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC...
K032420 · GAM
Ethicon, Inc.
General & Plastic Surgery · 78d
Cleared Oct 22, 2003
THERMASSAGE ENERGY PRODUCT, MODEL HY5000
K032449 · JFB
Migun Medical Instrument Co. , Ltd.
Physical Medicine · 75d
Cleared Oct 22, 2003
GE LOGIQ BOOK
K032477 · IYN
General Electric Co.
Radiology · 71d
Cleared Oct 22, 2003
T2 NAILING SYSTEM
K032523 · HSB
Howmedica Osteonics Corp.
Orthopedic · 68d