FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
125161–125184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1990
CHALLENGE 8000 POWERED MUSCLE STIMULATOR
K902512 · IPF
Maximum Performance Technologies,...
Physical Medicine · 87d
Cleared Aug 31, 1990
CHALLENGE 6010 POWERED MUSCLE STIMULATOR
K902513 · IPF
Maximum Performance Technologies,...
Physical Medicine · 87d
Cleared Aug 31, 1990
CHALLENGE 5010 POWERED MUSCLE STIMULATOR
K902514 · IPF
Maximum Performance Technologies,...
Physical Medicine · 87d
Cleared Aug 31, 1990
FIELD MEDICAL OXYGEN GEN/DIST SYS-BATTLEFIELD PURP
K903411 · CAW
Guild Assoc., Inc.
Anesthesiology · 32d
Cleared Aug 31, 1990
CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS
K903544 · LRP
J.J. Skinner, Inc.
General & Plastic Surgery · 25d
Cleared Aug 30, 1990
HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER
K894795 · KGI
Hologic, Inc.
Radiology · 406d
Cleared Aug 30, 1990
ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.
K896134 · GCX
Goosen Enterprises, Inc.
General Hospital · 310d
Cleared Aug 30, 1990
PERLINK SCREEN, KIRAN SCREEN
K896707 · EAM
Perlink USA, Inc.
Radiology · 275d
Cleared Aug 30, 1990
GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS
K896757 · FKP
Gambro, Inc.
Gastroenterology & Urology · 272d
Cleared Aug 30, 1990
THE MONITOR ELECTRONIC BED ALARM SYSTEM
K901330 · KMI
The Monitor Corp.
General Hospital · 161d
Cleared Aug 30, 1990
CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP
K902444 · DQI
Intramed Laboratories, Inc.
General Hospital · 90d
Cleared Aug 30, 1990
CATHSCANNER(R) PTA BALLOON DILATATION CATHETER
K902454 · LIT
Endosonics Corp.
Cardiovascular · 90d
Cleared Aug 30, 1990
CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY
K902464 · KPE
Chartermed, Inc.
General Hospital · 87d
Cleared Aug 30, 1990
BD FLEXIBLE DIGITAL THERMOMETER
K902624 · FLL
Bd Becton Dickinson Vacutainer...
General Hospital · 77d
Cleared Aug 30, 1990
CORPAK GRASPING FORCEPS
K902949 · OCZ
Corpak Co.
Gastroenterology & Urology · 56d
Cleared Aug 30, 1990
VISTA MR 2055 HP SYSTEM
K903048 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 50d
Cleared Aug 30, 1990
SMITH & NEPHEW DYONICS LEVELERT SYSTEM
K903193 · FLN
Smith & Nephew Dyonics, Inc.
General Hospital · 42d
Cleared Aug 30, 1990
UROMAT 2000
K903395 · IXR
Pausch Corp.
Radiology · 34d
Cleared Aug 30, 1990
NORTECH MODEL 87202204 ELECTRODE
K903554 · GXY
Medtronic Andover Medical, Inc.
Neurology · 23d
Cleared Aug 30, 1990
ARGIDENT YELLOW 3 GOLD ALLOY FOR PORCELAIN
K903680 · EJT
Argen Precious Metals, Inc.
Dental · 17d
Cleared Aug 30, 1990
ARGIDENT YELLOW 1 GOLD ALLOY FOR PORCELAIN
K903681 · EJT
Argen Precious Metals, Inc.
Dental · 17d
Cleared Aug 30, 1990
ARGILITE 1 GOLD ALLOY FOR PORCELAIN
K903682 · EJT
Argen Precious Metals, Inc.
Dental · 17d
Cleared Aug 30, 1990
ARGILITE 2 GOLD ALLOY FOR PORCELAIN
K903683 · EJT
Argen Precious Metals, Inc.
Dental · 17d
Cleared Aug 30, 1990
ARGIDENT 3 GOLD ALLOY FOR PORCELAIN
K903684 · EJT
Argen Precious Metals, Inc.
Dental · 17d