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

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176,076 results
65713–65736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2005
INVIEW
K051321 · LCP
Metrika, Inc.
Chemistry · 24d
Cleared Jun 13, 2005
ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM
K051402 · IYX
Gvi Technology Partners
Radiology · 13d
Cleared Jun 10, 2005
ARI COLD SPRAY
K033720 · MLY
Ari
Physical Medicine · 562d
Cleared Jun 10, 2005
RIVA PROTECT
K050871 · EBC
Southern Dental Industries, Inc.
Dental · 65d
Cleared Jun 10, 2005
XENFORM SOFT TISSUE REPAIR MATRIX
K051190 · PAJ
Tei Biosciences, Inc.
Obstetrics & Gynecology · 31d
Cleared Jun 10, 2005
EKOS MICRO-INFUSION SYSTEM
K051225 · NUI
Ekos Corp.
Neurology · 29d
Cleared Jun 10, 2005
BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG
K051228 · DSB
Cardiodynamics International Corp.
Cardiovascular · 28d
Cleared Jun 10, 2005
BIO-CONSOLE, MODEL 560
K051303 · DWA
Medtronic Perfusion Systems
Cardiovascular · 22d
Cleared Jun 10, 2005
LEVO COMFORT II
K051387 · IPL
Levo AG
Physical Medicine · 14d
Cleared Jun 09, 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · FRO
Medline Industries, Inc.
General & Plastic Surgery · 302d
Cleared Jun 09, 2005
MENDEC SPINE
K042415 · NDN
Tecres S.P.A.
Orthopedic · 275d
Cleared Jun 09, 2005
SUPERCATH Z3V
K050114 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 142d
Cleared Jun 09, 2005
VELASMOOTH, SHAPER
K050397 · NUV
Syneron Medical, Ltd.
General & Plastic Surgery · 113d
Cleared Jun 09, 2005
OLPUR DIALYZER, MODEL HD 190
K050603 · KDI
Nephros, Inc.
Gastroenterology & Urology · 92d
Cleared Jun 09, 2005
STERLING INTERFERENCE SCREW ST
K050767 · HWC
Regeneration Technologies, Inc.
Orthopedic · 76d
Cleared Jun 09, 2005
BASIS VERTEBRAL BODY SPACER
K051105 · MQP
Medtronic Sofamor Danek
Orthopedic · 38d
Cleared Jun 09, 2005
MODIFICATION TO: UNICAP SPECIFIC IGE
K051218 · DHB
Pharmacia Diagnostics AB
Immunology · 28d
Cleared Jun 09, 2005
AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K051250 · MAI
Axya Medical, Inc.
Orthopedic · 24d
Cleared Jun 08, 2005
PIEZOSURGERY DEVICE
K043408 · DZI
Piezosurgery S.R.L.
Dental · 180d
Cleared Jun 08, 2005
ENHANCE CLITORAL STIMULATION AID
K043480 · NBV
Gynavations, Inc.
Obstetrics & Gynecology · 174d
Cleared Jun 08, 2005
FRESENIUS ART HEMOADSORPTION SYSTEM
K050273 · LKN
Fresenius Medical Care North America
Gastroenterology & Urology · 121d
Cleared Jun 08, 2005
NOBELSPEEDY IMPLANTS
K050406 · DZE
Nobel Biocare AB
Dental · 111d
Cleared Jun 08, 2005
ON CALL MULTI-DRUG HOME TEST CUP
K050878 · LDJ
ACON Laboratories, Inc.
Chemistry · 63d
Cleared Jun 08, 2005
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
K050916 · PDU
Intra Luminal Therapeutics, Inc.
Cardiovascular · 57d