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
73225–73248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2003
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
K030378 · GXN
Stryker Instruments
Neurology · 43d
Cleared Mar 20, 2003
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
K030411 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 41d
Cleared Mar 20, 2003
ORIA ZENITH
K030500 · KWQ
Ortho Tec, LLC
Orthopedic · 29d
Cleared Mar 20, 2003
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
K030501 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Mar 20, 2003
DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
K030537 · GZJ
Well-Life Healthcare, Inc.
Neurology · 28d
Cleared Mar 20, 2003
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
K030597 · HRS
Synthes (Usa)
Orthopedic · 23d
Cleared Mar 20, 2003
EVA DIGITAL DENTAL X-RAY SYSTEM
K030647 · EHD
Afp Imaging Corp.
Radiology · 20d
Cleared Mar 20, 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698 · JXG
Aesculap, Inc.
Neurology · 14d
Cleared Mar 20, 2003
EBI DYNAFIX COMPRESSION BONE SCREW
K030706 · HWC
Ebi, L.P.
Orthopedic · 14d
Cleared Mar 20, 2003
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
K030814 · INI
Invacare Corp.
Physical Medicine · 6d
Cleared Mar 19, 2003
OPTION-VF URINARY CATHETER, FV14218
K023090 · EZL
Opticon Medical, Inc.
Gastroenterology & Urology · 183d
Cleared Mar 19, 2003
CHROMOCHECK PROTEIN C 25
K023990 · GGP
Precision Biologic
Hematology · 106d
Cleared Mar 19, 2003
SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
K030057 · MMI
Spectral Diagnostics, Inc.
Chemistry · 71d
Cleared Mar 19, 2003
HEMOSIL FACTOR XI DEFICIENT PLASMA
K030287 · GJT
Instrumentation Laboratory CO
Hematology · 50d
Cleared Mar 19, 2003
WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553
K030482 · JJY
Wiener Laboratories
Chemistry · 34d
Cleared Mar 19, 2003
IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
K030552 · HAW
Medtronic Surgical Navigation...
Neurology · 26d
Cleared Mar 19, 2003
ATAC CALIBRATOR
K030621 · JIX
Elan Diagnostics
Chemistry · 20d
Cleared Mar 18, 2003
SILVERLEAF CONTACT WOUND DRESSING
K013936 · FRO
Silverleaf Technologies, Inc.
General & Plastic Surgery · 475d
Cleared Mar 18, 2003
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022096 · KNK
Bayer Diagnostics Corp.
Chemistry · 264d
Cleared Mar 18, 2003
DSG RELAXER SPLINT
K022627 · MQC
Sentage Corporation D/B/A/ Dental...
Dental · 223d
Cleared Mar 18, 2003
XYLOS SURGICAL MESH
K023237 · FTM
Xylos Corporation
General & Plastic Surgery · 172d
Cleared Mar 18, 2003
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP,...
K023472 · GXZ
Class A Enterprises, Inc.
Neurology · 153d
Cleared Mar 18, 2003
ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES
K023954 · GEX
Altus Medical, Inc.
General & Plastic Surgery · 111d
Cleared Mar 18, 2003
SIGHTFIX
K024251 · GCJ
World of Medicine Lemke GmbH
General & Plastic Surgery · 85d