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
144625–144648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1986
SPOON
K854894 · KDC
Euro-Med Intl.
General & Plastic Surgery · 147d
Cleared May 02, 1986
BASKET FORCEP
K854895 · KDC
Euro-Med Intl.
General & Plastic Surgery · 147d
Cleared May 02, 1986
HOOK SCISSOR
K854896 · KDC
Euro-Med Intl.
General & Plastic Surgery · 147d
Cleared May 02, 1986
MAX-I-GRASP
K854897 · KDC
Euro-Med Intl.
General & Plastic Surgery · 147d
Cleared May 02, 1986
ATLANTIC GRASPER
K854898 · KDC
Euro-Med Intl.
General & Plastic Surgery · 147d
Cleared May 02, 1986
PACIFIC GRASPER
K854901 · KDC
Euro-Med Intl.
General & Plastic Surgery · 147d
Cleared May 02, 1986
SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC
K854998 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 141d
Cleared May 02, 1986
SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT
K855210 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 123d
Cleared May 02, 1986
HEART CATHETERIZATION TRAY
K860161 · DRE
Medical Design Concepts, Inc.
Cardiovascular · 106d
Cleared May 02, 1986
VOROBA PROGRAMMABLE AUDITORY COMPARATOR
K860171 · KHL
Voroba Technologies Assoc.
Ear, Nose, Throat · 105d
Cleared May 02, 1986
ANGIOMAT 6000
K860204 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 100d
Cleared May 02, 1986
POSID SAMPLER
K860508 · JQW
Organon Teknika Corp.
Chemistry · 80d
Cleared May 02, 1986
NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH
K860526 · DXO
Nova Medical Specialties
Cardiovascular · 80d
Cleared May 02, 1986
VACO SUCTION ELECTRODE UNIT
K860758 · IPF
Zimmer Elektromedizin GmbH
Physical Medicine · 63d
Cleared May 02, 1986
MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT
K860940 · ETF
Micromedics, Inc.
Ear, Nose, Throat · 51d
Cleared May 02, 1986
DIRECTACLONE CG SLIDE PREGNANCY TEST
K860945 · JHJ
Pacific Biotech, Inc.
Chemistry · 51d
Cleared May 02, 1986
SCM-400 HOLTER SYSTEM
K860950 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 51d
Cleared May 02, 1986
ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM
K860981 · GCY
Sun Technologies
General & Plastic Surgery · 49d
Cleared May 02, 1986
SCLEROTHERAPY INJECTION CATHETER
K860991 · KNT
Endovations
Gastroenterology & Urology · 46d
Cleared May 02, 1986
VOX COMPANION
K860992 · ESE
Bloomfield Research and Development,...
Ear, Nose, Throat · 46d
Cleared May 02, 1986
GASTROINTESTINAL CYTOLOGY BRUSH
K860997 · FDX
Endovations
Gastroenterology & Urology · 45d
Cleared May 02, 1986
MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA
K861046 · LNK
Sharplan Industries, Inc.
Gastroenterology & Urology · 45d
Cleared May 02, 1986
ORTHOJOIN, ORTHODONTIC ADHESIVE
K861118 · DYH
Ortho Source
Dental · 38d
Cleared May 02, 1986
PROGRAMALITH III PULSE GENERATOR
K861140 · DXY
Pacesetter Systems
Cardiovascular · 37d