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
55345–55368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 2008
CARAPASTE ORAL WOUND DRESSING
K082856 · OLR
Mcgrath Pharmaceuticals, Inc.
General & Plastic Surgery · 16d
Cleared Oct 15, 2008
VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2
K082890 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 15d
Cleared Oct 15, 2008
HRB-127-32 HIGH RESOLUTION BRAIN COIL
K082916 · MOS
Invivo
Radiology · 15d
Cleared Oct 14, 2008
PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE...
K081793 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 111d
Cleared Oct 14, 2008
COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
K082012 · GXI
Cosman Medical, Inc.
Neurology · 91d
Cleared Oct 14, 2008
GS III FIXTURE SYSTEM
K082213 · DZE
Osstem Implant Co., Ltd.
Dental · 69d
Cleared Oct 14, 2008
DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE
K082447 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 50d
Cleared Oct 14, 2008
SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100
K082543 · IYO
Sonocine, Inc.
Radiology · 41d
Cleared Oct 14, 2008
4D VIEWER RADIOLOGY, MODEL USWP-100A
K082684 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 29d
Cleared Oct 14, 2008
MRDH BANDAGE
K082703 · KMF
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 28d
Cleared Oct 14, 2008
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
K082828 · GAQ
Suturtek Incorporated
General & Plastic Surgery · 19d
Cleared Oct 10, 2008
5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT
K073368 · DZE
Bicon, LLC
Dental · 315d
Cleared Oct 10, 2008
VITRIFICATION KIT & VITRIFICATION WARMING KIT
K073522 · MQL
Sage In-Vitro Fertilization, Inc.
Obstetrics & Gynecology · 301d
Cleared Oct 10, 2008
DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE
K080399 · MBP
Musculoskeletal Transplant Foundation
Orthopedic · 239d
Cleared Oct 10, 2008
A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
K080851 · LPS
Anticancer, Inc.
Chemistry · 198d
Cleared Oct 10, 2008
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
K081107 · KWP
K2m, Inc.
Orthopedic · 175d
Cleared Oct 10, 2008
HEM-9000AI
K081654 · DXN
Omron Healthcare, Inc.
Cardiovascular · 120d
Cleared Oct 10, 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · MQV
Baxter Healthcare Corp
Orthopedic · 114d
Cleared Oct 10, 2008
ENSPLINTCMX CLAVICLE PIN
K081832 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 105d
Cleared Oct 10, 2008
SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
K081890 · GKZ
Sysmex America, Inc.
Hematology · 100d
Cleared Oct 10, 2008
STARR FRAME STEINMANN PIN
K082017 · HTY
Starr Frame, LLC
Orthopedic · 86d
Cleared Oct 10, 2008
T2 FLEXIBLE NAIL
K082018 · HSB
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Oct 10, 2008
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI...
K082046 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 84d
Cleared Oct 10, 2008
MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK
K082052 · DQA
Masimo Corporation
Anesthesiology · 81d