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

Filters: Cleared only ×
176,076 results
154297–154320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1984
SYRINGE, PISTON, ARTERIAL BLOOD SAMPL
K840924 · FMF
Medcare Disp Products, Inc.
General Hospital · 21d
Cleared Mar 23, 1984
OHIO HEAT REFLECTING PATCH
K840967 · FMI
Ohio Medical Products
General Hospital · 17d
Cleared Mar 23, 1984
PRESERV TRANSPORT & CULTURE PACK
K840968 · JTW
Preventive Diagnostics Corp.
Microbiology · 17d
Cleared Mar 23, 1984
NIACIN REAGENT STRIP
K840981 · MJD
Remel Co.
Microbiology · 17d
Cleared Mar 23, 1984
PRESERV CARY BLAIR TRANSPORT PACK
K840990 · JTW
Preventive Diagnostics Corp.
Microbiology · 16d
Cleared Mar 23, 1984
PRESERV BUFFERED GLYCEROL SALINE
K840991 · JTW
Preventive Diagnostics Corp.
Microbiology · 16d
Cleared Mar 23, 1984
HEMOGLOBIN REAGENT SET
K841057 · GKR
Medical Specialties, Inc.
Hematology · 11d
Cleared Mar 23, 1984
NASOPHARYNGEAL AIRWAYS
K841093 · BTQ
Inmed Corp.
Anesthesiology · 10d
Cleared Mar 23, 1984
HP-20, 30, 40, 50 & 60
K841100 · IRT
Associated Mills, Inc.
Physical Medicine · 10d
Cleared Mar 23, 1984
HEKTOEN ENTERIC AGAR
K841129 · JSI
Anaerobe Systems
Microbiology · 7d
Cleared Mar 23, 1984
TRYPTICASE SOY AGAR W/5% SHEEP BLOOD
K841130 · JSG
Anaerobe Systems
Microbiology · 7d
Cleared Mar 23, 1984
XYLOSE LYSINE DESOXYCHOLATE AGAR
K841131 · JSI
Anaerobe Systems
Microbiology · 7d
Cleared Mar 23, 1984
EILE-ESCULIN AZIDE AGAR
K841132 · JSI
Anaerobe Systems
Microbiology · 7d
Cleared Mar 23, 1984
THAYER MARTIN MEDIUM
K841133 · JSJ
Anaerobe Systems
Microbiology · 7d
Cleared Mar 23, 1984
CSPI PREMIUM SURGICAL ASPIRATOR
K841242
Custom Surgical Products, Inc.
Cardiovascular
Cleared Mar 22, 1984
PATIENT MONITOR #404
K831319 · KLK
Analogic Corp.
Anesthesiology · 335d
Cleared Mar 22, 1984
SERVOMED COMPACT MONITOR SMK 155-7/101
K832025 · DRT
Litton Medical Electronics
Cardiovascular · 273d
Cleared Mar 22, 1984
SEVOMED COMPACT MONITOR SMK 154-
K832095 · DRT
Litton Medical Electronics
Cardiovascular · 268d
Cleared Mar 22, 1984
MODEL TTPM TIME TEMP. PRESSURE MONITOR
K832897 · DRS
Electromedics, Inc.
Cardiovascular · 213d
Cleared Mar 22, 1984
HEMODYNAMIC PLUG-IN MODULE 78551A
K833913 · DXG
Hewlett-Packard Co.
Cardiovascular · 129d
Cleared Mar 22, 1984
CARDIAC OUTPUT SIGNAL ACQUISTION
K833914 · DXG
Hewlett-Packard Co.
Cardiovascular · 129d
Cleared Mar 22, 1984
HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN
K834117 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
MCCOY CELLS
K834119 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
LLC-MK2-RHESUS MONKEY KIDNEY CELLS
K834120 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d