FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
164761–164784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 31, 1980
RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &
K802936 · GQG
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
RUBELLA VIRUS ANTIGENS & CONTROLS
K802937 · GON
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
VARICELLA-ZOSTER ANTIGENS & CONTROLS
K802938 · GQW
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
HERPES SIMPLEX TYPE I
K802939 · GON
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
TRANSDUCER DOME, CAT.#SD-101
K802961 · DRQ
Sorensen Research
Cardiovascular · 40d
Cleared Dec 31, 1980
DISPOSABLE DIAPHRAGM DONE
K803011 · DRQ
Sorensen Research
Cardiovascular · 33d