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
68881–68904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2004
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
K040755 · MQV
Exactech, Inc.
Orthopedic · 85d
Cleared Jun 17, 2004
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
K040837 · MSS
Medicel AG
Ophthalmic · 78d
Cleared Jun 17, 2004
MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
K040847 · CCK
Draeger Medical, Inc.
Anesthesiology · 77d
Cleared Jun 17, 2004
INTEGRA BONE FIXATION SYSTEM
K040860 · HRS
Integra LifeSciences Corporation
Orthopedic · 76d
Cleared Jun 17, 2004
CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
K040864 · GXN
Aesculap
Neurology · 76d
Cleared Jun 17, 2004
NEUROQ - PET DP
K041022 · KPS
Syntermed, Inc.
Radiology · 58d
Cleared Jun 17, 2004
HSG CATHETER SET
K041094 · LKF
Bioteque America, Inc.
Obstetrics & Gynecology · 51d
Cleared Jun 17, 2004
FSH MENOPAUSE PREDICTOR TEST
K041165 · CGJ
ACON Laboratories, Inc.
Chemistry · 44d
Cleared Jun 17, 2004
THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
K041200 · JFB
Migun Medical Instrument Co. , Ltd.
Physical Medicine · 41d
Cleared Jun 17, 2004
MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)
K041229 · ELW
Cosmedent, Inc.
Dental · 38d
Cleared Jun 17, 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
K041322 · DHX
Ortho-Clinical Diagnostics, Inc.
Immunology · 30d
Cleared Jun 17, 2004
AEQUALIS SHOULDER SYSTEM
K041339 · KWS
Tornier
Orthopedic · 28d
Cleared Jun 17, 2004
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
K041476 · LNH
Ge Medical Systems, LLC
Radiology · 14d
Cleared Jun 17, 2004
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
K041487 · MOS
Usa Instruments, Inc.
Radiology · 13d
Cleared Jun 17, 2004
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS
K041542 · JAK
Neusoft Digital Medical Systems Co.,...
Radiology · 9d
Cleared Jun 16, 2004
DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100...
K033896 · MKJ
Defibtech, LLC
Cardiovascular · 183d
Cleared Jun 16, 2004
BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
K040030 · DCN
Biocheck, Inc.
Immunology · 161d
Cleared Jun 16, 2004
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
K040332 · JJF
Arkray, Inc.
Chemistry · 127d
Cleared Jun 16, 2004
RANDOX IMMUNOASSAY CONTROL
K040379 · JJY
Randox Laboratories, Ltd.
Chemistry · 120d
Cleared Jun 16, 2004
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I
K040443 · LLZ
Dome Imaging Systems, Inc.
Radiology · 117d
Cleared Jun 16, 2004
CALIBRA CEMENT
K040906 · EMA
Dentsply Intl.
Dental · 70d
Cleared Jun 16, 2004
DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES
K040967 · LYZ
Zi BO Hong Wang Plastic & Rubber...
General Hospital · 63d
Cleared Jun 16, 2004
VARELISA MPO ANCA, MODEL 17648/17696
K041040 · MOB
Sweden Diagnostics (Germany) GmbH
Immunology · 55d
Cleared Jun 16, 2004
DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
K041141 · EFB
Dentsply Intl.
Dental · 47d