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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
115105–115128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1992
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
K924643 · DWF
Medtronic Bio-Medicus, Inc.
Cardiovascular · 85d
Cleared Dec 08, 1992
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
K924712 · MCW
Hearing Tech, Inc.
Cardiovascular · 81d
Cleared Dec 08, 1992
TAPER GUIDEWIRES
K924987 · DQX
Target Therapeutics
Cardiovascular · 55d
Cleared Dec 07, 1992
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
K915320 · DHR
Trinity Laboratories, Inc.
Immunology · 381d
Cleared Dec 07, 1992
ULTRASOUND GENERATOR MODLE 2270
K920235 · FEO
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 325d
Cleared Dec 07, 1992
REMSTAR WTIH RAMP AND REMOTE MODIFICATION
K920699 · BZD
Respironics, Inc.
Anesthesiology · 313d
Cleared Dec 07, 1992
VIGIL II
K920845 · DCK
Beckman Instruments, Inc.
Microbiology · 286d
Cleared Dec 07, 1992
EASYFLOW
K922112 · BZQ
Epm Information Systems, Inc.
Anesthesiology · 216d
Cleared Dec 07, 1992
ARGYLE AERO-JET SUCTION CATHETER
K922148 · BSY
Sherwood Medical Co.
Anesthesiology · 214d
Cleared Dec 07, 1992
COAMATE PROTEIN C CHROMOGENIC ASSAY
K922201 · GGP
Chromogenix AB
Hematology · 210d
Cleared Dec 07, 1992
CHOLERASCREEN
K922432 · GSQ
New Horizons Diagnostics Co.
Microbiology · 199d
Cleared Dec 07, 1992
NEOPLASTINE(R) CI KIT
K922565 · GJS
American Bioproducts Co.
Hematology · 189d
Cleared Dec 07, 1992
PORTABLE PATIENT MONITOR
K922974 · MHX
Hewlett-Packard Co.
Cardiovascular · 168d
Cleared Dec 07, 1992
AMCATH DISPOSABLE CYTOLOGY BRUSH
K923200 · FDX
Intl. Medical, Inc.
Gastroenterology & Urology · 160d
Cleared Dec 07, 1992
ORTHOMET PERFECTA TOTAL HIP SYSTEM
K923583 · LZO
Orthomet, Inc.
Orthopedic · 140d
Cleared Dec 07, 1992
ABSORBENT PAD -- MODIFICATION
K923602 · NAB
Winfield Laboratories, Inc.
General & Plastic Surgery · 145d
Cleared Dec 07, 1992
MISTY OX LAMINAR DIFFUSER HUMIDIFIER
K923754 · BTT
Medical Molding Corp. of America
Anesthesiology · 132d
Cleared Dec 07, 1992
ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE
K923879 · JQW
Diagnostic Products Corp.
Chemistry · 126d
Cleared Dec 07, 1992
ACCUTEX ASO LATEX TEST
K924247 · GTQ
J.S. Medical Assoc.
Microbiology · 105d
Cleared Dec 07, 1992
ACCUTEX CRP LATEX TEST
K924332 · DCK
J.S. Medical Assoc.
Immunology · 102d
Cleared Dec 07, 1992
DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)
K924552 · IXW
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 89d
Cleared Dec 07, 1992
CYTOQUANT HNFS CELLS
K924595 · KIR
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT MCCOY CELLS/ONE DRAM SHELL VIAL #02-301
K924612 · KIR
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301
K924613 · KIR
Proteins Intl., Inc.
Pathology · 87d