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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122617–122640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1991
KINETIC ALKALINE PHOSPHATASE DETERMINATION
K905650 · CJE
Biochemical Trade, Inc.
Chemistry · 57d
Cleared Feb 13, 1991
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
K905707 · FGE
Baxter Healthcare Corp
Gastroenterology & Urology · 54d
Cleared Feb 13, 1991
CLEARBLUE EASY
K905742 · LCX
Unipath , Ltd.
Chemistry · 51d
Cleared Feb 13, 1991
VPW2877E7 X RAY POWER SUPPLY
K905855 · IZO
Varian Canada, Inc.
Radiology · 54d
Cleared Feb 13, 1991
AVD INTIMAX (TM) BILIARY CATHETER
K910006 · FGE
Applied Vascular
Gastroenterology & Urology · 42d
Cleared Feb 13, 1991
MILENIA COCAINE METABOLITE
K910044 · KLN
Diagnostic Products Corp.
Toxicology · 40d
Cleared Feb 13, 1991
K-MODULE II HEAT THERAPY SYSTEM
K910061 · ILO
Baxter Healthcare Corp
Physical Medicine · 35d
Cleared Feb 13, 1991
CHILDREN SUNGLASSES
K910141 · HQY
Consolidated Stores Intl. Corp.
Ophthalmic · 30d
Cleared Feb 13, 1991
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K910249 · CHP
Baxter Healthcare Corp
Chemistry · 22d
Cleared Feb 12, 1991
MAXI ASPIRATOR
K902184 · BTI
Medical Industries America, Inc.
Anesthesiology · 274d
Cleared Feb 12, 1991
FLEXCOMP DSP & PROCOMP
K903497 · HCC
Thought Technology , Ltd.
Neurology · 193d
Cleared Feb 12, 1991
#504 MINI COMPRESSOR
K904045 · BTI
Medical Industries America, Inc.
Anesthesiology · 161d
Cleared Feb 12, 1991
PATIENT EXAM GLOVES(MFG: YUNG CHIEH ENTERPRISE)
K904839 · LYY
Up TO Date, Inc.
General Hospital · 117d
Cleared Feb 12, 1991
STANDARD BREAST BOARDS
K905007 · IYE
Bionix Development Corp.
Radiology · 98d
Cleared Feb 12, 1991
APOLLO MOBILE SCALE
K905061 · FRW
Apollo Enterprise, Ltd. Co.
General Hospital · 95d
Cleared Feb 12, 1991
ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K905252 · ITX
Ge Medical Systems Information...
Radiology · 81d
Cleared Feb 12, 1991
SAFE-SITE NEEDLE COVER
K905305 · FMI
North American Medical Products, Inc.
General Hospital · 76d
Cleared Feb 12, 1991
EXIT ALARM
K905421 · KMI
Alertcare
General Hospital · 70d
Cleared Feb 12, 1991
COBE CENTRY 2 BICART OPTION KIT
K905793 · FKP
Cobe Laboratories, Inc.
Gastroenterology & Urology · 47d
Cleared Feb 12, 1991
BONE PAD REMOVER
K910225 · HAO
Acra Cut, Inc.
Neurology · 25d
Cleared Feb 12, 1991
DURAL DISSECTORS
K910226 · HAO
Acra Cut, Inc.
Neurology · 25d
Cleared Feb 12, 1991
PATIENT EXAMINATION GLOVES
K910442 · LYY
Asian Latex, Ltd.
General Hospital · 12d
Cleared Feb 11, 1991
CASTABLE ABUTMENTS
K900694 · DZE
Calcitek, Inc.
Dental · 363d
Cleared Feb 11, 1991
ULTRASOUND COUPLING GEL
K904418 · JOT
Geno Laboratories
General & Plastic Surgery · 137d