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
48049–48072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2011
BD FACS SAMPLE PREP ASSISTANT III (SPA III)
K102064 · GKZ
Becton, Dickinson & CO
Hematology · 227d
Cleared Mar 07, 2011
PALLA M SPINAL SYSTEM
K102574 · MNH
Korea Bone Bank Co., Ltd.
Orthopedic · 180d
Cleared Mar 07, 2011
EU-TTG IGA AND EU-TTG IGG
K102964 · MVM
Grifols USA, Inc.
Immunology · 153d
Cleared Mar 07, 2011
ALEUTTIAN
K103169 · ODP
K2m, Inc.
Orthopedic · 131d
Cleared Mar 07, 2011
GEM OPTION FOR 1.5 MRI SYSTEMS
K103335 · MOS
Ge Healthcare
Radiology · 112d
Cleared Mar 07, 2011
FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
K103400 · OLO
Stryker Corporation
Radiology · 108d
Cleared Mar 07, 2011
THORACIC VCAR
K103480 · LLZ
Ge Medical Systems, LLC
Radiology · 101d
Cleared Mar 04, 2011
STERRAD 100NX STERILIZER EXPRESS CYCLE
K092622 · MLR
Advanced Sterilization Products
General Hospital · 555d
Cleared Mar 04, 2011
EZ-MISTER
K093584 · CCT
N.M. Beale Co., Inc.
Anesthesiology · 470d
Cleared Mar 04, 2011
PULMOTRACK 2020 SYSTEM
K102229 · BZM
Karmelsonix
Anesthesiology · 207d
Cleared Mar 04, 2011
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
K102320 · IRP
Daesung Maref Co., Ltd.
Physical Medicine · 199d
Cleared Mar 04, 2011
QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL...
K102464 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 189d
Cleared Mar 04, 2011
FLAATZ 750E
K102474 · MQB
Drtech Corp.
Radiology · 186d
Cleared Mar 04, 2011
FOCUS EMG DEVICE
K102610 · IKN
Teleemg, LLC USA
Neurology · 175d
Cleared Mar 04, 2011
SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY,...
K102642 · IYN
Sonoscape Company Limited
Radiology · 172d
Cleared Mar 04, 2011
SOMATOM DEFINITION AS
K103127 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Mar 04, 2011
RAUMEDIC- ICP-MONITORING SYSTEM
K103206 · GWM
Raumedic AG
Neurology · 123d
Cleared Mar 04, 2011
TRIO TRAUMA SPINAL SYSTEM
K103292 · NKB
Stryker Corporation
Orthopedic · 116d
Cleared Mar 04, 2011
VIEWPOINT 6
K103458 · LLZ
Ge Healthcare
Radiology · 101d
Cleared Mar 04, 2011
CERAMIC FEMORAL HEAD
K103497 · MEH
United Orthopedic Corp.
Orthopedic · 95d
Cleared Mar 04, 2011
BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP
K103585 · EMA
Harry J. Bosworth Co.
Dental · 87d
Cleared Mar 04, 2011
PARIETEX PROGRIP
K103682 · FTL
Sofradim Production
General & Plastic Surgery · 77d
Cleared Mar 04, 2011
SYNAPSE 3D CEREBRAL ANALYSIS
K103687 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 77d
Cleared Mar 04, 2011
BARCO MAMMO TOMOSYNTHESIS
K103792 · LLZ
Barco N.V.
Radiology · 67d