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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
162673–162696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1981
ZIKON 100 DIGITAL X-RAY SYSTEM
K813032 · JAB
Kontron Instruments, Inc.
Radiology · 27d
Cleared Nov 24, 1981
COMPTAR III
K813051 · IZO
Cgr Medical Corp.
Radiology · 26d
Cleared Nov 24, 1981
SPINAL WRENCH
K813067 · HXC
Twin City Surgical, Inc.
Orthopedic · 25d
Cleared Nov 24, 1981
COMPOSITE DENTAL RESTORATIVE MATERIAL
K813090 · EBF
Sci-Pharm, Inc.
Dental · 22d
Cleared Nov 24, 1981
FISSURE SEALER & BONDING AGENT
K813091 · EBC
Sci-Pharm, Inc.
Dental · 22d
Cleared Nov 24, 1981
BACK RIE
K813099 · ION
Back Rite
Physical Medicine · 21d
Cleared Nov 24, 1981
POLI-MAK II
K813102 · JJE
Pm America, Inc.
Chemistry · 21d
Cleared Nov 24, 1981
PORT-OP
K813106 · EIA
Portec, Inc.
Dental · 21d
Cleared Nov 24, 1981
S/P VORTEX MIXER
K813148 · JRQ
American Dade
Chemistry · 18d
Cleared Nov 24, 1981
S/P VORTEX MIXER JR.
K813149 · JRQ
American Dade
Chemistry · 18d
Cleared Nov 24, 1981
ORTHO UNASSAYED CONTROL SERUM LEVEL II
K813167 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 12d
Cleared Nov 24, 1981
SALICYLATE STAT-PAK
K813185 · DKJ
Clin Tech Diagnostics Corp.
Toxicology · 8d
Cleared Nov 23, 1981
MODEL P-8 PROFESSIONAL
K811114
Bloomex International, Inc.
Physical Medicine · 214d
Cleared Nov 20, 1981
HYDROXYLAPATITE
K811101 · LYC
Carbomedics, Inc.
Dental · 213d
Cleared Nov 20, 1981
IMAGER 2000 REAL TIME SYSTEM
K811842 · IYO
Siemens Gammasonics, Inc.
Radiology · 142d
Cleared Nov 20, 1981
X-RAY DETECTABLE BAND
K812017 · GDY
Isramed, Inc.
Radiology · 126d
Cleared Nov 20, 1981
X-RAY DETECTABLE THREAD
K812018 · GDY
Isramed, Inc.
Radiology · 126d
Cleared Nov 20, 1981
PORTABLE TOOTHBRUSH KIT (NO SAMPLE)
K812361 · EFW
Jdm Commodities
Dental · 92d
Cleared Nov 20, 1981
DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST
K812362 · EFW
Jdm Commodities
Dental · 92d
Cleared Nov 20, 1981
DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED
K812363 · EFW
Jdm Commodities
Dental · 92d
Cleared Nov 20, 1981
PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE
K812364 · EFW
Jdm Commodities
Dental · 92d
Cleared Nov 20, 1981
ARTHRO-PREP REST W/STAND
K812395 · BWN
Northwest Surgical Concepts, Inc.
General & Plastic Surgery · 92d
Cleared Nov 20, 1981
ARTHRO-PREP REST
K812396 · BWN
Northwest Surgical Concepts, Inc.
General & Plastic Surgery · 92d
Cleared Nov 20, 1981
TANARAMA
K812603 · GGG
Marketing Consultants of America
Radiology · 66d