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
153457–153480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 22, 1984
WI-38 HUMAN LUNG CELLS
K834123 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
VERO CELLS
K834124 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
MRC-5 CELLS
K834126 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
PBS W/MG+2 & CA+2
K834136 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 113d
Cleared Mar 22, 1984
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
K834191 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 122d
Cleared Mar 22, 1984
JAKOBI SURG. INSTRUMENTS #3 21/22/24
K834192 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 122d