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

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175,820 results
48601–48624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 2011
SYNTHES 6.0 COCR AND CPT TI-3 RODS
K103287 · NKB
Synthes Spine
Orthopedic · 65d
Cleared Jan 05, 2011
SPINEANALYER MODEL SAPOC
K103475 · LLZ
Optasia Medical
Radiology · 42d
Cleared Jan 05, 2011
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
K103534 · DQY
Trireme Medical, Inc.
Cardiovascular · 35d
Cleared Jan 05, 2011
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K103618 · MCW
Ev3, Inc.
Cardiovascular · 26d
Cleared Jan 05, 2011
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
K103722 · ITX
Medison Co., Ltd.
Radiology · 15d
Cleared Jan 04, 2011
CERAROOT IMPLANT SYSTEM
K093595 · DZE
Oral Iceberg S.L.
Dental · 411d
Cleared Jan 04, 2011
RADSCAN EQUIPMENT SLICKER
K101350 · KKX
Radscan Medical Equipment, Inc.
General Hospital · 235d
Cleared Jan 04, 2011
DUAL INCU I
K102226 · FMZ
Atom Medical Corporation
General Hospital · 148d
Cleared Jan 04, 2011
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
K102974 · MSX
Philips Medical Systems
Cardiovascular · 90d
Cleared Jan 04, 2011
CONGRUENT BONE PLATE SYSTEM
K102998 · HRS
Acumed, LLC
Orthopedic · 88d
Cleared Jan 04, 2011
YOBOSHI DENTAL UNIT
K103550 · EIA
Fosham Yoboshi Medical Equipment Co.,...
Dental · 32d
Cleared Jan 03, 2011
PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113,...
K101853 · NOE
Diadexus, Inc.
Chemistry · 186d
Cleared Jan 03, 2011
KRYSTALRAD 560 (FLAATZ 560)
K102284 · KPR
Medicatech USA
Radiology · 144d
Cleared Jan 03, 2011
KRYSTALRAD (ATAL8)
K102285 · KPR
Medicatech USA
Radiology · 144d
Cleared Jan 03, 2011
SUPER CHAIR FOR KIDS BY ORION
K103073 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 77d
Cleared Jan 03, 2011
1.5T 16-CHANNEL HAND-WRIST COIL
K103149 · MOS
Invivo Corporation
Radiology · 70d
Cleared Jan 03, 2011
ROUGHRIDER
K103212 · IOR
Whirlwind Wheelchair International
Physical Medicine · 63d
Cleared Jan 03, 2011
I-SEED
K103319 · KXK
Theragenics Corp.
Radiology · 52d
Cleared Jan 03, 2011
TANDA MAX
K103415 · ONE
Pharos Life Corporation
General & Plastic Surgery · 42d
Cleared Jan 03, 2011
F20
K103433 · NDN
Teknimed, S.A.
Orthopedic · 40d
Cleared Jan 03, 2011
DX-D 100
K103597 · IZL
Agfa Healthcare N.V.
Radiology · 26d
Cleared Dec 30, 2010
LUPOTEK KCT
K090105 · GGW
R2 Diagnostics, Inc.
Hematology · 714d
Cleared Dec 30, 2010
CANTATA MICROCATHETER
K101450 · KRA
Cook, Inc.
Cardiovascular · 220d
Cleared Dec 30, 2010
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
K102616 · FDF
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 111d