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

Filters: Cleared only ×
175,820 results
48745–48768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2010
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
K103360 · JIT
Siemens Corp.
Chemistry · 31d
Cleared Dec 17, 2010
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
K103392 · NFB
Inovo, Inc.
Anesthesiology · 28d
Cleared Dec 17, 2010
UNITY NETWORK ID
K103432 · MWI
Ge Medical Systems Information...
Cardiovascular · 24d
Cleared Dec 17, 2010
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
K103538 · JTN
Hardy Diagnostics
Microbiology · 15d
Cleared Dec 16, 2010
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K093299 · OAT
Synthes (Usa)
Dental · 421d
Cleared Dec 16, 2010
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
K100646 · DTM
Medtronic, Inc.
Cardiovascular · 286d
Cleared Dec 16, 2010
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE
K101363 · ODP
Musculoskeletal Clinical Regulatory...
Orthopedic · 216d
Cleared Dec 16, 2010
EUROMI EVA SP6
K101413 · QPB
Euromi S.A
General & Plastic Surgery · 210d
Cleared Dec 16, 2010
GNR TRAFFIC LIGHT PNA FISH
K101558 · JSS
Advandx, Inc.
Microbiology · 195d
Cleared Dec 16, 2010
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL...
K101659 · DQY
Vascular Solutions, Inc.
Cardiovascular · 188d
Cleared Dec 16, 2010
STRAUMANN MEMBRAGEL
K101956 · NPK
Straumann USA (On Behalf of Institut...
Dental · 157d
Cleared Dec 16, 2010
PEAK PULSAR II GENERATOR MODEL PS100-102
K102029 · GEI
Peak Surgical, Inc.
General & Plastic Surgery · 150d
Cleared Dec 16, 2010
STIMPOD NMS450 NERVE STIMULATOR
K102084 · BXN
Xavant Technology (Pty), Ltd.
Anesthesiology · 143d
Cleared Dec 16, 2010
ENDO FLIP
K102214 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 132d
Cleared Dec 16, 2010
EXPEDIUM SPINE SYSTEM
K102249 · NKB
Depuy Spine, A Johnson & Johnson Company
Orthopedic · 129d
Cleared Dec 16, 2010
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
K102323 · OVE
Theken Spine, LLC
Orthopedic · 121d
Cleared Dec 16, 2010
VIPI BLOCK
K102341 · EBG
Vipi Industria,Comercio,Exportacao E...
Dental · 120d
Cleared Dec 16, 2010
GSP NEONATAL IRT KIT (3306-001U)
K102419 · JNO
Wallac Oy, Subsidiary of Perkinelmer
Chemistry · 113d
Cleared Dec 16, 2010
AVITA WRIST TYPE BLOOD PRESSURE MONITOR
K102624 · DXN
Avita Corporation
Cardiovascular · 94d
Cleared Dec 16, 2010
CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY
K102755 · GEX
Biolitec, Inc.
General & Plastic Surgery · 84d
Cleared Dec 16, 2010
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
K102766 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 83d
Cleared Dec 16, 2010
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K103147 · MNI
Medyssey Co, Ltd.
Orthopedic · 52d
Cleared Dec 16, 2010
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE...
K103249 · LZA
Cardinal Health, Inc.
General Hospital · 43d
Cleared Dec 16, 2010
POSTERIOR LATERAL PLATES
K103408 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 27d