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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
47161–47184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2011
VISTA DIGITAL OPTHALMOSCOPE
K102412 · HKI
Eyequick.Llc
Ophthalmic · 303d
Cleared Jun 23, 2011
CENTURION PRESSURE INJECTABLE EXTENSION SET
K103562 · FPA
Centurion Medical Products Corporation
General Hospital · 199d
Cleared Jun 23, 2011
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
K110239 · LDJ
Lin-Zhi International, Inc.
Chemistry · 148d
Cleared Jun 23, 2011
SOUND SURGICAL VASER 2.1 LIPO SYSTEM
K110306 · QPB
Sound Surgical Technologies, LLC
General & Plastic Surgery · 141d
Cleared Jun 23, 2011
STAT-MAT MINOR
K110500 · KCT
Macpherson Medical, Inc.
General Hospital · 121d
Cleared Jun 23, 2011
INOMAX DS(IR) (DELIVERY SYSTEM)
K110635 · MRN
Ino Therapeutics, LLC/Dba Ikaria
Anesthesiology · 111d
Cleared Jun 23, 2011
SURGICAL PROCEDURE PACKS
K110724 · FYA
Omnia Spa
General Hospital · 99d
Cleared Jun 23, 2011
CUROS PORT PROTECTOR
K110826 · QBP
Ivera Medical
General Hospital · 91d
Cleared Jun 23, 2011
METAL OPAQUER
K110859 · EBF
Apex Dental Materials, Inc.
Dental · 87d
Cleared Jun 23, 2011
ACTIVE WASTE GAS SCAVENGER
K110930 · CBN
G. Dundas Co.,Inc.
Anesthesiology · 80d
Cleared Jun 23, 2011
15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE...
K111581 · NHA
Nobel Biocare AB
Dental · 16d
Cleared Jun 23, 2011
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
K111657 · KFM
Medtronic, Inc.
Cardiovascular · 9d
Cleared Jun 22, 2011
CORELEADER ALGIPLASTER MODEL AP 050501
K102942 · FRO
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 261d
Cleared Jun 22, 2011
CUTERA QSWITCH LASER SYSTEM
K102954 · GEX
Cutera, Inc.
General & Plastic Surgery · 260d
Cleared Jun 22, 2011
THE SENSITITRE AIM
K103456 · LIE
Trek Diagnostic Systems
Microbiology · 210d
Cleared Jun 22, 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
K110647 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 107d
Cleared Jun 22, 2011
ALEUTIAN SPACER SYSTEM
K110843 · MAX
K2m, Inc.
Orthopedic · 89d
Cleared Jun 22, 2011
PALOMAR ICON (TM) AESTHETIC SYSTEM
K110907 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 83d
Cleared Jun 22, 2011
SURGIVISION INC. CLEARPOINT SYSTEM
K111073 · ORR
Surgi-Vision, Inc.
Radiology · 65d
Cleared Jun 22, 2011
THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
K111138 · DYB
Access Scientific, Inc.
Cardiovascular · 61d
Cleared Jun 22, 2011
APEX PS KNEE SYSTEM - PS-C INSERT
K111184 · JWH
Omni Life Science, Inc.
Orthopedic · 56d
Cleared Jun 22, 2011
MICROSCAN MICROSTEP
K111394 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 35d
Cleared Jun 22, 2011
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
K111444 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Jun 21, 2011
ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
K101005 · NHA
Astra Tech AB
Dental · 435d