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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
146737–146760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1985
I.S.M. PRODUCT FAMILY MODEL R3600C
K854170 · FTC
Intl. Solarium Manufacturer, Inc.
General & Plastic Surgery · 24d
Cleared Nov 08, 1985
GOLDEN RULE SUN TANNING BEDS
K854224 · FTC
Golden Rule Tanning Co., Inc.
General & Plastic Surgery · 21d
Cleared Nov 08, 1985
CHURCHILL 3-WAY STOPCOCK SET
K854348 · FMG
Churchill Corp.
General Hospital · 10d
Cleared Nov 07, 1985
HEARING AID(ALL IN EAR)
K852244 · ESD
Olympia Instruments, Inc.
Ear, Nose, Throat · 168d
Cleared Nov 07, 1985
ECHO TYPE 16 CF ANTIGEN
K853156 · GNK
Hillcrest Biologicals
Microbiology · 100d
Cleared Nov 07, 1985
ECHO TYPE 11 CF ANTIGEN
K853157 · GNK
Hillcrest Biologicals
Microbiology · 100d
Cleared Nov 07, 1985
THE VICKERS STANDARD MICROSURGERY SET
K853161 · GZX
Keeler Instruments, Inc.
Neurology · 100d
Cleared Nov 07, 1985
ECHO TYPE 30 CF ANTIGEN
K853165 · GNK
Hillcrest Biologicals
Microbiology · 100d
Cleared Nov 07, 1985
VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND
K853179 · GZX
Keeler Instruments, Inc.
Neurology · 100d
Cleared Nov 07, 1985
CMV CF ANTIGEN
K853277 · GQI
Hillcrest Biologicals
Microbiology · 94d
Cleared Nov 07, 1985
POLIO TYPE I CF ANTIGEN, & TYPE II, III
K853278 · GOG
Hillcrest Biologicals
Microbiology · 94d
Cleared Nov 07, 1985
COXSACKIE A2 CF ANTIGEN, A4, A10 & A16
K853279 · GNO
Hillcrest Biologicals
Microbiology · 94d
Cleared Nov 07, 1985
MES-TENS(TENS)
K853416 · GZJ
Oriental Medical Supplies, Inc.
Neurology · 85d
Cleared Nov 07, 1985
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K853523 · DYH
Dentsply Intl.
Dental · 77d
Cleared Nov 07, 1985
MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING
K853569 · BYX
Medipart Jerry Alexander
Anesthesiology · 73d
Cleared Nov 07, 1985
MEDIPART DRIERITE MP-1002
K853570 · IYT
Medipart Jerry Alexander
Radiology · 73d
Cleared Nov 07, 1985
MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M
K853576 · IYT
Medipart Jerry Alexander
Radiology · 73d
Cleared Nov 07, 1985
MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133
K853579 · IYT
Medipart Jerry Alexander
Radiology · 73d
Cleared Nov 07, 1985
ALLERG-E IGE ENZYME IMMUNOASSAY KIT
K853607 · DGO
Dexall Biomedical Labs, Inc.
Immunology · 71d
Cleared Nov 07, 1985
BELIEVE HEAVY FLOW PROTECTION LABIAL PADS
K853630 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 69d
Cleared Nov 07, 1985
UNITRON MODEL UM60-D
K853780 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Nov 07, 1985
UNITRON MODEL UM60-PP
K853781 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Nov 07, 1985
GOLDEN CERAMIC
K853982 · EJT
Wiliams Gold Refining Co., Inc.
Dental · 41d
Cleared Nov 07, 1985
RESIN TRAY IMPRESSION MATERIAL
K854042 · EBH
Dentsply Intl.
Dental · 36d