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
165601–165624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1981
ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE
K801802 · DPW
Medical Testing System, Inc.
Cardiovascular · 157d
Cleared Jan 02, 1981
IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS
K802413 · DTB
Telectronics, Inc.
Cardiovascular · 88d
Cleared Jan 02, 1981
K-KATH URETHRAL CATHETER INTRODUCER
K802878 · KOD
B&K Medical
Gastroenterology & Urology · 46d
Cleared Jan 02, 1981
CORTISOL 125-I RADIOIMMUNOASSAY KIT
K802969 · CGR
Ria Products, Inc.
Chemistry · 42d
Cleared Jan 02, 1981
LEECO TESTO-QUANT DIAGNOSTIC KIT
K803001 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 38d
Cleared Jan 02, 1981
CHLORIDE/TCO2 ANALYZER REAGENTS
K803013 · CHJ
Laboratory Products, Inc.
Chemistry · 35d
Cleared Jan 02, 1981
RIAPHASE (125I) PROST. ACID PHOSPH. KIT
K803043 · JFH
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Jan 02, 1981
IMMU-TRACE T3 UPTAKE (T3U) REAGENTS
K803044 · KHQ
American Dade
Chemistry · 32d
Cleared Jan 02, 1981
IMMU-TRACE T4 RIA PROCEDURE
K803046 · CDX
American Dade
Chemistry · 32d
Cleared Jan 02, 1981
LANCER CREATININE MICROSAMPLE STAT ANA
K803087 · CGX
Sherwood Medical Co.
Chemistry · 25d
Cleared Jan 02, 1981
MAGNESIUM TEST KIT
K803088 · JGJ
Mallinckrodt Critical Care
Chemistry · 25d
Cleared Jan 02, 1981
GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)
K803089 · JPZ
Environmental Chemical Specialties
Chemistry · 25d
Cleared Dec 31, 1980
UCLA SHOULDER
K801970 · KWS
Howmedica Corp.
Orthopedic · 134d
Cleared Dec 31, 1980
WISCONSIN DUAL-PHOTON BONE ANALYZER
K802180 · KGI
Lunar Radiation Corp.
Radiology · 113d
Cleared Dec 31, 1980
WISCONSIN BONE MINERAL ANALYZER
K802181 · KGI
Lunar Radiation Corp.
Radiology · 113d
Cleared Dec 31, 1980
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT
K802268 · KHG
R&D Systems, Inc.
Hematology · 106d
Cleared Dec 31, 1980
NUVOX BEDSIDE TINNITUS MASKER
K802750 · KLW
Hal-Hen Co., Inc.
Ear, Nose, Throat · 57d
Cleared Dec 31, 1980
SELECTIVE CHARCOAL YEAST EXTRACT AGAR
K802758 · JSJ
Remel Co.
Microbiology · 57d
Cleared Dec 31, 1980
BEHIND-THE-EAR HEARING AID
K802859 · ESD
Danavox, Inc.
Ear, Nose, Throat · 49d
Cleared Dec 31, 1980
ADENO VIRUS & CONTROLS
K802929 · GOD
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
MEASLES VIRUS & CONTROLS
K802932 · GRJ
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
MUMPS S & V ANTIGENS & CONTROLS
K802933 · GRC
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL
K802934 · GSB
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR
K802935 · GQS
Orion Diagnostica, Inc.
Microbiology · 42d