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
69241–69264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2004
RANDOX AMPHETAMINE CLASS ASSAY
K040350 · DKZ
Randox Laboratories, Ltd.
Toxicology · 90d
Cleared May 12, 2004
HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15
K040381 · MQV
Arthrex, Inc.
Orthopedic · 85d
Cleared May 12, 2004
TRIFLANGE II ACETABULAR CUP SYSTEM
K040383 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared May 12, 2004
AESKULISA CARDIOLIPIN AGM
K040463 · MID
Aesku, Inc.
Immunology · 79d
Cleared May 12, 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040939 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared May 12, 2004
MODIFICATION TO INFINITY EXPLORER
K040945 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 30d
Cleared May 12, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE...
K040955 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 29d
Cleared May 12, 2004
10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88
K041056 · FLL
Mesure Technology Co., Ltd.
General Hospital · 19d
Cleared May 12, 2004
KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT
K041072 · IOR
Invacare Corporation
Physical Medicine · 16d
Cleared May 12, 2004
INFINITY GAMMA
K041087 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 16d
Cleared May 11, 2004
Y2K2 ENTERNAL FEEDING MANAGER
K030413 · KNT
Moss Medical Products
Gastroenterology & Urology · 459d
Cleared May 11, 2004
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC...
K032016 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 316d
Cleared May 11, 2004
BIOTOP DJT-A SAFETY SYRINGE
K032747 · MEG
Biotop Technology Co., Ltd.
General Hospital · 250d
Cleared May 11, 2004
CHAD THERAPEUTICS SAGE
K033364 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 203d
Cleared May 11, 2004
CRADLE PACS
K033912 · LLZ
Cradle Technology Corp.
Radiology · 146d
Cleared May 11, 2004
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
K040208 · QSY
Tz Medical, Inc.
General & Plastic Surgery · 102d
Cleared May 11, 2004
LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY...
K040424 · GEX
Clarus Medical, LLC
General & Plastic Surgery · 83d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
K040449 · MSV
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
K040450 · MSV
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
K040451 · MSV
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
K040452 · MSV
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 11, 2004
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D
K040585 · IYE
Brainlab AG
Radiology · 67d
Cleared May 11, 2004
STANDARD IMAGING E.IMRT CALCULATOR
K040688 · MUJ
Standard Imaging, Inc.
Radiology · 56d
Cleared May 11, 2004
FOX PLUS PTA CATHETER
K040954 · LIT
Abbott Laboratories, Inc.
Cardiovascular · 28d