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
155233–155256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 1984
DIRIA-PROGK IMMUNOASSAY
K832694 · JLS
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 154d
Cleared Jan 11, 1984
CHEM TRAK LIQUID BILIRUBIN CONTROL
K833097 · JJX
Medical Analysis Systems, Inc.
Chemistry · 121d
Cleared Jan 11, 1984
AZLOCILLIN 75MCG. SENSITIVITY DISCS
K833414 · JTN
Difco Laboratories, Inc.
Microbiology · 100d
Cleared Jan 11, 1984
TICARCILLIN 75MCG. SENSITIVITY DISCS
K833415 · JTN
Difco Laboratories, Inc.
Microbiology · 100d
Cleared Jan 11, 1984
CEFTIZOXIME 30 MCG SENSITIVITY DISCS
K833416 · JTN
Difco Laboratories, Inc.
Microbiology · 100d
Cleared Jan 11, 1984
ADRENOCOR TICOTROPIC HORMONE RADIOIMM
K833471 · CKG
Nichols Institute Diagnostics
Chemistry · 97d
Cleared Jan 11, 1984
IL MODEL 840 MICROPROCESSOR LOADER
K833505 · JQW
Instrumentation Laboratory CO
Chemistry · 92d
Cleared Jan 11, 1984
REAGENT TESTS STRIP COMBINATIONS
K833521 · JJB
Syn-Kit, Inc.
Chemistry · 92d
Cleared Jan 11, 1984
CENTRAL VEIN CATH. TRAY CC-20-1420
K833573 · DQY
Intermed, Inc.
Cardiovascular · 91d
Cleared Jan 11, 1984
PERCUTANEOUS SHEATH INTRODUCER TRAYS
K833574 · DQX
Intermed, Inc.
Cardiovascular · 91d
Cleared Jan 11, 1984
GOLD ALLIGATOR FORCEPS
K833608 · KAE
Microtek Medical, Inc.
Ear, Nose, Throat · 91d
Cleared Jan 11, 1984
PORTA PULSE III #D320
K833751 · LDD
Medical Research Laboratories, Inc.
Cardiovascular · 77d
Cleared Jan 11, 1984
HAMILTON PEDIATRICS SCALE
K833754 · FRW
Befour, Inc.
General Hospital · 77d
Cleared Jan 11, 1984
SOMAS CHLORIDE ASSAY KIT
K833787
Somas Medical Industries, Inc.
Chemistry · 72d
Cleared Jan 11, 1984
AMERICAN GOLD SERIES AUTOCLAVE
K833837 · FLE
Tuttnauer Co. , Ltd.
General Hospital · 69d
Cleared Jan 11, 1984
MICRO INFUSION SET
K833949 · FPA
Deltec Systems, Inc.
General Hospital · 57d
Cleared Jan 11, 1984
CVA
K833967 · JSJ
Remel Co.
Microbiology · 56d
Cleared Jan 11, 1984
STRIP SPLITTER II -HALF WIDTH CARRIER
K834150 · JJQ
Larken Industries, Inc.
Hematology · 41d
Cleared Jan 10, 1984
ATAC 3000
K832115 · JJE
Turpen Laboratory Systems, Inc.
Chemistry · 194d
Cleared Jan 10, 1984
TELEMETRY SYS SERIES 7700 ECG
K832817 · DRG
Marquette Electronics, Inc.
Cardiovascular · 144d
Cleared Jan 10, 1984
INVASIVE MONITORING KITS
K832907 · DRS
American Pharmaseal Div. Ahsc
Cardiovascular · 134d
Cleared Jan 10, 1984
GELENDER VACUUM FIXATION RING SYS
K832912 · HNH
Miami Eye Technology, Inc.
Ophthalmic · 134d
Cleared Jan 10, 1984
WELLCOGEN N. MENINGITIDIS A,C,Y W135
K833063 · GTJ
Wellcome Diagnostics
Immunology · 123d
Cleared Jan 10, 1984
WELLCOGEN H. INFLUENZAL ZL21
K833077 · GRD
Wellcome Diagnostics
Immunology · 123d