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
118081–118104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1992
GI BLEEDER/OD SET
K913476 · KNT
Icu Medical, Inc.
Gastroenterology & Urology · 191d
Cleared Feb 12, 1992
STABILET INFANT RADIANT WARMER MODEL 2000C
K913945 · FMT
Hill-Rom, Inc.
General Hospital · 161d
Cleared Feb 12, 1992
I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR
K914118 · FYD
I.C Medical, Inc.
General Hospital · 152d
Cleared Feb 12, 1992
SUREBREATH DOME, E-Z BREATHER
K915158 · GAD
Ipax, Inc.
General & Plastic Surgery · 90d
Cleared Feb 12, 1992
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K915282 · LLL
Hemagen Diagnostics, Inc.
Immunology · 79d
Cleared Feb 12, 1992
PHACO 3000 LINEAR
K915456 · HQC
Innovative Medical Systems, Inc.
Ophthalmic · 69d
Cleared Feb 12, 1992
SIMPLASTIN L
K915746 · GJS
Organon Teknika Corp.
Hematology · 51d
Cleared Feb 12, 1992
KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE
K920031 · JAC
Eastman Kodak Company
Radiology · 40d
Cleared Feb 11, 1992
MEDSCOPE 8MM AND 10MM LAPAROSCOPE
K903663 · HET
Medscope Corp.
Obstetrics & Gynecology · 546d
Cleared Feb 11, 1992
OBUTMENT HB
K903999 · DZE
"O" Co., Inc.
Dental · 531d
Cleared Feb 11, 1992
PRE-ANGLED ABUTMENTS
K912059 · DZE
Core-Vent Corp.
Dental · 278d
Cleared Feb 11, 1992
PERMANENT CARDIAC PACING LEADS AND ADAPTORS
K912464 · DTB
Medtronic Vascular
Cardiovascular · 252d
Cleared Feb 11, 1992
PERSONAL BODY MASSAGER, MODELS 1605 & 1606
K912822 · ISA
Raymond Industrial, Ltd.
Physical Medicine · 231d
Cleared Feb 11, 1992
INJECTION CAP
K913337 · FPA
Cp Medical
General Hospital · 200d
Cleared Feb 11, 1992
SUNSHADES, ACRYLIC LENSES, SILVER COATED #HX-602
K913686 · HQY
Tel-Time Products
Ophthalmic · 176d
Cleared Feb 11, 1992
EXCELSIOR SINGLE LEAD DISPENSING SET
K913804 · LHI
Excel Medical, Inc.
General Hospital · 169d
Cleared Feb 11, 1992
GUIDER, DASHER
K914030 · DQX
Target Therapeutics
Cardiovascular · 154d
Cleared Feb 11, 1992
GUIDER-22
K914031 · DQX
Target Therapeutics
Cardiovascular · 154d
Cleared Feb 11, 1992
NITINOL SEEKER(R) GUIDE WIRES
K914032 · DQX
Target Therapeutics
Cardiovascular · 154d
Cleared Feb 11, 1992
SAUNETTE, PORTABLE STEAM CABIN
K914234 · IMB
Sauna Magic, Inc.
Physical Medicine · 144d
Cleared Feb 11, 1992
ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
K914550 · LKJ
Diagnostic Resources, Inc.
Immunology · 123d
Cleared Feb 11, 1992
MULTIPULSE SEQUENTIAL COMPRESSION UNIT
K914774 · IRP
Talley Group, Ltd.
Physical Medicine · 111d
Cleared Feb 11, 1992
I.V.IRRIGATION POLE
K915065 · FOZ
American Medical Mfg., Inc.
General Hospital · 95d
Cleared Feb 11, 1992
TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST
K915092 · IRP
Progressive Medical Technology, Inc.
Physical Medicine · 82d