FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
123745–123768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1990
HIGH RISK
K903559 · LYY
Medical Resources, Ltd.
General Hospital · 135d
Cleared Dec 21, 1990
CHIROFLEX FORCEPS
K903575 · KYB
Chiron Ophthalmics
Ophthalmic · 135d
Cleared Dec 21, 1990
ARIES MELDICAL MODEL 2100HC HANK CRANK
K903925 · KFM
Aries Medical, Inc.
Cardiovascular · 130d
Cleared Dec 21, 1990
SEROFAST
K903958 · GSA
Intl. Mycoplasma/Mdc Assoc.
Microbiology · 115d
Cleared Dec 21, 1990
MICRO-MIST NEBULIZER
K904196 · CAF
Bp , Ltd.
Anesthesiology · 100d
Cleared Dec 21, 1990
SURGICAL TROCAR AND CANNULA
K904379 · HET
Applied Vascular Devices, Inc.
Obstetrics & Gynecology · 87d
Cleared Dec 21, 1990
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED
K904523 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 86d
Cleared Dec 21, 1990
KAPPER
K904527 · EJI
Senair-Mot
Dental · 80d
Cleared Dec 21, 1990
ENEMA BULB
K904534 · FCE
R.A.C., Inc.
Gastroenterology & Urology · 78d
Cleared Dec 21, 1990
BONE STAPLE(S)
K904553 · JDR
Synthes (Usa)
Orthopedic · 77d
Cleared Dec 21, 1990
QAR HANDPIECE
K904671 · EFB
Collagen Corp.
Dental · 70d
Cleared Dec 21, 1990
STERILE SURGICAL GLOVES/DOUBLE GLOVER
K905012 · KGO
American Advisors, Inc.
General Hospital · 45d
Cleared Dec 21, 1990
MICRO-AIRE MODEL NUMBER: MK-426
K905097 · HBE
Micro Surgical Instruments Corp.
Neurology · 38d
Cleared Dec 21, 1990
X-L AND X-LX
K905325 · EJT
Ivoclar North America, Inc.
Dental · 23d
Cleared Dec 21, 1990
MRT35-SP
K905442 · LNH
Toshiba America Mri, Inc.
Radiology · 87d
Cleared Dec 21, 1990
PATIENT EXAM GLOVES(MFG: LIAONING MACHINERY)
K905585 · LYY
Pioneer Trading Co.
General Hospital · 8d
Cleared Dec 21, 1990
ELLIPSE 2.3
K905621 · IOR
Everest & Jennings, Inc.
Physical Medicine · 7d
Cleared Dec 20, 1990
THE OMNIFIT EPF HIP JOINT FEMORAL STEM
K896047 · MEH
Osteonics Corp.
Orthopedic · 428d
Cleared Dec 20, 1990
BODYHEAT
K902650 · DWJ
Medadvances, Inc.
Cardiovascular · 188d
Cleared Dec 20, 1990
KETOREX SANWA STANDARDS
K903365 · JIN
Ihara Medics U.S., Inc.
Chemistry · 147d
Cleared Dec 20, 1990
MAGNUM-20 (TM) INFLATION DEVICE
K903621 · MAV
Vascumed Systems
Cardiovascular · 134d
Cleared Dec 20, 1990
MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
K903993 · DKZ
Immunotech Corp.
Chemistry · 113d
Cleared Dec 20, 1990
CARDIOMATIC MODEL MSC-2001
K904353 · DRT
Medical Systems Corp.
Cardiovascular · 87d
Cleared Dec 20, 1990
ANEROID BLOOD PRESSURE GAUGE
K904376 · FCY
Biomedical Dynamics, Inc.
Gastroenterology & Urology · 86d