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
70801–70824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2003
OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E
K023452 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 401d
Cleared Nov 20, 2003
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING...
K023537 · LYY
Sgmp Co., Ltd.
General Hospital · 395d
Cleared Nov 20, 2003
SYSTEM 100 ULTRAFILTRATION CATHETER
K023874 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 364d
Cleared Nov 20, 2003
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K030958 · MNI
Ortho Tec, LLC
Orthopedic · 238d
Cleared Nov 20, 2003
SCORPIO NRG KNEE SYSTEM
K030978 · JWH
Howmedica Osteonics Corp.
Orthopedic · 237d
Cleared Nov 20, 2003
BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580
K031375 · IPF
Besmed Health Business Corp
Physical Medicine · 204d
Cleared Nov 20, 2003
GROWTH GUIDANCE PLATE
K031493 · HRS
University of Utah/School of Medicine
Orthopedic · 192d
Cleared Nov 20, 2003
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q,...
K031676 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 174d
Cleared Nov 20, 2003
ARAMIS II DERMATOLOGICAL LASER
K032260 · GEX
Quantel Medical
General & Plastic Surgery · 121d
Cleared Nov 20, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286 · MQV
Biomet Orthopedics, Inc.
Orthopedic · 119d
Cleared Nov 20, 2003
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT...
K032331 · HBL
Pro-Med Instruments GmbH
Neurology · 114d
Cleared Nov 20, 2003
QUASAR, MODEL MD21
K032379 · ILY
Quantum Skincare, Inc.
Physical Medicine · 111d
Cleared Nov 20, 2003
TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE
K032613 · LDF
Peter M. Rothenberg, M.D.
Cardiovascular · 87d
Cleared Nov 20, 2003
PLASTALGIN AND PLASTALGIN ORTHO
K032708 · ELW
Septodont
Dental · 79d
Cleared Nov 20, 2003
UCR SPINAL SYSTEM
K032739 · MNI
Seaspine
Orthopedic · 77d
Cleared Nov 20, 2003
NEUROLASE, MODELS 150V, 150C, 1064
K032787 · ILY
Spectrum Laser & Technologies
Physical Medicine · 73d
Cleared Nov 20, 2003
BI-ANGULAR SHOULDER SYSTEM
K032895 · MBF
Biomet, Inc.
Orthopedic · 64d
Cleared Nov 20, 2003
FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
K032907 · LYZ
Shijiazhuang Fuguan Plastic Products...
General Hospital · 64d
Cleared Nov 20, 2003
FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K032908 · LYZ
Shijiazhuang Fuguan Plastic Products...
General Hospital · 64d
Cleared Nov 20, 2003
EPI-SCAN, MODEL P 100
K032935 · GZO
Edx Epi-Scan, Inc.
Neurology · 59d
Cleared Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150...
K032938 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 59d
Cleared Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50...
K032940 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 59d
Cleared Nov 20, 2003
SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
K032995 · ELC
Micron Corp.
Dental · 56d
Cleared Nov 20, 2003
TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
K033035 · ILY
Tlc Marketing, Inc.
Physical Medicine · 52d