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
150913–150936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1984
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
K844196 · KME
Biological & Environmental Control...
General Hospital · 35d
Cleared Dec 04, 1984
TRACHEAL TUBE, REINFORCED, CUFFED
K844296 · BTR
Sheridan Catheter Corp.
Anesthesiology · 28d
Cleared Dec 04, 1984
OXYGEN CONCENTRATOR
K844328 · CAW
Hospitak, Inc.
Anesthesiology · 27d
Cleared Dec 04, 1984
DYNASCOPE MONITOR DS-800
K844348 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 35d
Cleared Dec 04, 1984
MEDIPART FILTER & TUBING MP-02X
K844491 · CAH
Medipart Jerry Alexander
General Hospital · 14d
Cleared Dec 04, 1984
MEDIPART BACTERIA FILTER MP-30X
K844492 · CAH
Medipart Jerry Alexander
General Hospital · 14d
Cleared Dec 04, 1984
MEDIPART FACE MASK & FILTER MP-30XM
K844493 · BSJ
Medipart Jerry Alexander
Anesthesiology · 14d
Cleared Dec 04, 1984
MEDIPART FACE MASK MP-XM
K844494 · BSJ
Medipart Jerry Alexander
Anesthesiology · 14d
Cleared Dec 03, 1984
PULSE GENERATOR 689, 689B & 689L
K841225 · DXY
Siemens Elema AB
Cardiovascular · 256d
Cleared Dec 03, 1984
PULSE GENERATOR 686, 686B 686L
K841230 · DXY
Siemens Elema AB
Cardiovascular · 256d
Cleared Dec 03, 1984
PULSE GENERATOR 696, 696B & 696L
K841232 · DXY
Siemens Elema AB
Cardiovascular · 256d
Cleared Dec 03, 1984
DEL MAR AVIONICS 5509 NEURO-SCANNER
K841653 · GWQ
Del Mar Avionics
Neurology · 224d
Cleared Dec 03, 1984
EASY EYES TM LENS CARRYING CASE
K841881 · HPX
Eaton Medical Corp.
Ophthalmic · 210d
Cleared Dec 03, 1984
FLUOROSKAN
K842049 · JZT
Flow Laboratories, Inc.
Immunology · 195d
Cleared Dec 03, 1984
CREDENT RADIOPAQUE CROWN & BRIDE
K842476 · EBI
Credent Co.
Dental · 161d
Cleared Dec 03, 1984
CREDENT RADIOPAQUE DENTURE RESIN
K842477 · EBI
Credent Co.
Dental · 161d
Cleared Dec 03, 1984
DESERET INTRAVASCULAR CATHETER
K843033 · FOZ
Parke-Davis Co.
General Hospital · 124d
Cleared Dec 03, 1984
HEARING AIDS 372 & 372 AI
K843068 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 119d
Cleared Dec 03, 1984
FILAFEX TM, ESTHETIC ORTHODONTIC WIRE
K843171 · DZC
Berkley and Co.
Dental · 112d
Cleared Dec 03, 1984
ACTIVE VERTICAL CORRECTOR ACTIVE BITE
K843344 · ECO
Active Vertical Correctors, Inc.
Dental · 98d
Cleared Dec 03, 1984
TRANSDUCER FOR KONTROL 5MHZ SIGMA 20
K843355 · MHZ
Kontron Instruments, Inc.
Neurology · 98d
Cleared Dec 03, 1984
PLAYTEX BABY POWDER DEODORANT TAMPONS
K843551 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 84d
Cleared Dec 03, 1984
AUDIOMETER
K843618 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 80d
Cleared Dec 03, 1984
ISOSTATIC CONDENSER
K843901 · EKG
Shofu Dental Corp.
Dental · 61d