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
56881–56904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2008
INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM
K073690 · HIH
Interlace Medical, Inc.
Obstetrics & Gynecology · 111d
Cleared Apr 17, 2008
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K080070 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 98d
Cleared Apr 17, 2008
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
K080525 · GEX
Cook Urological, Inc.
General & Plastic Surgery · 51d
Cleared Apr 17, 2008
DIGITAL LIGHTBOX
K080608 · LLZ
Brainlab AG
Radiology · 44d
Cleared Apr 17, 2008
LOW FLUID ALARM
K080704 · FLN
Em-Tec GmbH
General Hospital · 36d
Cleared Apr 17, 2008
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
K080774 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 29d
Cleared Apr 17, 2008
BIOMOVE 5000 SYSTEM
K080787 · IPF
Curatronic, Ltd.
Physical Medicine · 28d
Cleared Apr 17, 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
K080863 · DQX
MicroVention, Inc.
Cardiovascular · 20d
Cleared Apr 16, 2008
RAMP INFLUENZA A/B ASSAY
K071591 · PSZ
Response Biomedical Corp.
Microbiology · 310d
Cleared Apr 16, 2008
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED...
K072814 · KDD
Covidien
General & Plastic Surgery · 198d
Cleared Apr 16, 2008
SURGICASE
K073449 · LLZ
Materialise NV
Radiology · 128d
Cleared Apr 16, 2008
TURBO PRIME IBD SYSTEM
K080058 · MAX
Spineselect, LLC
Orthopedic · 98d
Cleared Apr 16, 2008
OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS
K080082 · CAW
Oxlife, LLC
Anesthesiology · 96d
Cleared Apr 16, 2008
MANUAL RIGID MOBILITY WHEELCHAIR
K080270 · IOR
Freedom Designs, Inc.
Physical Medicine · 75d
Cleared Apr 16, 2008
SIERRA SYSTEM
K080526 · KWP
Seaspine, Inc.
Orthopedic · 50d
Cleared Apr 16, 2008
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
K080553 · KPR
Vieworks Co., Ltd.
Radiology · 48d
Cleared Apr 16, 2008
PALOMAR ASPIRE LASER PLATFORM
K080567 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 47d
Cleared Apr 16, 2008
C-QUR LITE MESH V-PATCH
K080688 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 36d
Cleared Apr 16, 2008
C-QUR EDGE MESH V-PATCH
K080691 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 36d
Cleared Apr 16, 2008
ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
K080736 · MQV
Apatech , Ltd.
Orthopedic · 30d
Cleared Apr 16, 2008
ONCENTRA GYN
K080929 · MUJ
Nucletron Corporation
Radiology · 15d
Cleared Apr 15, 2008
COMPORUS
K062691 · MQV
Takiron Co., Ltd.
Orthopedic · 582d
Cleared Apr 15, 2008
DIO IMPLANT SYSTEM
K070570 · DZE
Dio Department Dsi, Inc.
Dental · 412d
Cleared Apr 15, 2008
MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
K072614 · LYY
Matang Mfg. Sdn. Bhd.
General Hospital · 211d