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
62449–62472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2006
VIPER SPINE SYSTEM
K061520 · NKB
Depuy Spine, Inc.
Orthopedic · 21d
Cleared Jun 23, 2006
EBI ARRAY SPINAL SYSTEM
K061563 · NKB
Ebi, L.P.
Orthopedic · 18d
Cleared Jun 23, 2006
FULLCARD ANALYSIS
K061587 · KPS
Ge Healthcare
Radiology · 15d
Cleared Jun 22, 2006
AG-PLUS, MODEL 91210
K060404 · CAF
Medel S.P.A.
Anesthesiology · 127d
Cleared Jun 22, 2006
LUNG FLUTE
K060439 · BYI
Medical Acoustics, LLC
Anesthesiology · 121d
Cleared Jun 22, 2006
4CIS VANE SPINE SYSTEM
K060702 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 98d
Cleared Jun 22, 2006
TRIAGE TOX DRUG SCREEN, MODEL 94400
K060791 · DJR
Biosite Incorporated
Toxicology · 91d
Cleared Jun 22, 2006
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES
K061120 · HQD
Synergeyes, Inc.
Ophthalmic · 62d
Cleared Jun 22, 2006
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K061157 · MVN
Bausch & Lomb
Ophthalmic · 57d
Cleared Jun 22, 2006
ILED
K061317 · FSY
Trumpf Kreuzer Medizin Systeme GmbH +...
General & Plastic Surgery · 42d
Cleared Jun 22, 2006
HI-TORQUE WHISPER VIEW GUIDE WIRE
K061453 · DQX
Guidant Corp.
Cardiovascular · 28d
Cleared Jun 22, 2006
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
K061503 · DLJ
Dade Behring, Inc.
Toxicology · 21d
Cleared Jun 22, 2006
NEMIO XG, SAA-580A
K061605 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Jun 21, 2006
CONFIDENCE HIGH VISCOSITY BONE CEMENT
K060300 · NDN
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 135d
Cleared Jun 21, 2006
SOYALA, SOYALA BLUE
K060405 · BZD
Weinmann Gerate Fur Medizin GmbH +...
Anesthesiology · 125d
Cleared Jun 21, 2006
REVJET TURBO
K060842 · CAF
Promedic, Inc.
Anesthesiology · 85d
Cleared Jun 21, 2006
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
K061024 · HQF
Peregrine Surgical , Ltd.
Ophthalmic · 69d
Cleared Jun 21, 2006
DEPOTONE
K061032 · FMI
Imprint Pharmaceuticals Limited
General Hospital · 68d
Cleared Jun 21, 2006
MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR
K061205 · BTA
Medela AG
General & Plastic Surgery · 51d
Cleared Jun 21, 2006
A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR
K061456 · DXN
A&D Engineering, Inc.
Cardiovascular · 27d
Cleared Jun 21, 2006
SMDIE DEVICE INTERFACING SYSTEM
K061590 · MWI
Siemens Medical Solutions Health...
Cardiovascular · 13d
Cleared Jun 21, 2006
DEFIBRILLATOR CABLE TESTER, MODEL DT2200
K061606 · DRG
Medical Devices/Padpro, Inc.
Cardiovascular · 12d
Cleared Jun 20, 2006
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597,...
K061089 · KYI
Biopro, Inc.
Orthopedic · 63d
Cleared Jun 20, 2006
NANOLITE SKIN CARE SYSTEM
K061117 · GEX
Nanolite Technology, Inc.
General & Plastic Surgery · 60d