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
80833–80856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2001
EXCITE DSC
K003293 · KLE
Ivoclar North America, Inc.
Dental · 109d
Cleared Feb 06, 2001
PALMLIGHT
K003383 · EBZ
Ultradent Products, Inc.
Dental · 98d
Cleared Feb 06, 2001
TAI-CHI ACUPUNCTURE NEEDLES
K003760 · MQX
Lhasa Medical, Inc.
General Hospital · 62d
Cleared Feb 06, 2001
COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
K003958 · FZP
Coalescent Surgical
General & Plastic Surgery · 47d
Cleared Feb 06, 2001
SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT...
K004048 · LYY
Tillotson Healthcare Corp.
General Hospital · 39d
Cleared Feb 06, 2001
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+,...
K010238 · FLL
Actherm, Inc.
General Hospital · 12d
Cleared Feb 06, 2001
SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES
K010247 · LZA
Shanghai China Star Corp
General Hospital · 11d
Cleared Feb 05, 2001
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
K001781 · OLX
Neurosoft, Inc.
Neurology · 237d
Cleared Feb 05, 2001
MODULAR
K001988 · BSZ
Heyer America, Inc.
Anesthesiology · 221d
Cleared Feb 05, 2001
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
K002201 · CAH
Sims Portex, Inc.
General Hospital · 200d
Cleared Feb 05, 2001
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
K002280 · MKJ
Medical Devices, Inc.
Cardiovascular · 194d
Cleared Feb 05, 2001
RANDOX TRANSFERRIN
K002585 · DDG
Randox Laboratories, Ltd.
Chemistry · 168d
Cleared Feb 05, 2001
MINIQUANT D-DIMER, MODEL 1447
K002642 · DAP
Biopool Intl., Inc.
Hematology · 165d
Cleared Feb 05, 2001
MICTEC ENDOSCOPES AND ACCESSORIES
K002877 · GEI
Dufner Instrumente GmbH
General & Plastic Surgery · 143d
Cleared Feb 05, 2001
TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310
K003478 · LPH
Zimmer, Inc.
Orthopedic · 88d
Cleared Feb 05, 2001
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · LPS
Diagnostic Products Corp.
Toxicology · 76d
Cleared Feb 05, 2001
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY...
K003704 · BZQ
Optovent AB
Anesthesiology · 66d
Cleared Feb 05, 2001
ADVIA 120 HEMATOLOGY
K003796 · GKZ
Bayer Corp.
Hematology · 59d
Cleared Feb 05, 2001
INTRAVASCULAR ADMINISTRATION SET
K003854 · FPA
Infusion Devices, Inc.
General Hospital · 54d
Cleared Feb 05, 2001
LIVESURE THC SCREEN TEST
K010001 · LDJ
Pan Probe Biotech, Inc.
Toxicology · 34d
Cleared Feb 05, 2001
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
K010050 · CGN
Bayer Diagnostics Corp.
Chemistry · 31d
Cleared Feb 05, 2001
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
K010081 · KWY
Exactech, Inc.
Orthopedic · 26d
Cleared Feb 05, 2001
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
K993600 · LIH
Nisha Communication Industries
Neurology · 469d
Cleared Feb 02, 2001
SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS
K001965 · FMI
North American Medical Products, Inc.
General Hospital · 219d