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
70537–70560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2003
HYDROPHILIC GUIDEWIRE
K033758 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 17d
Cleared Dec 19, 2003
ALLEGRO IMAGING SYSTEM
K033782 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Dec 19, 2003
PLASMACURE BXE
K033795 · EBZ
Eele Laboratories, LLC
Dental · 14d
Cleared Dec 19, 2003
SIENET COSMOS
K033831 · LLZ
Siemens AG Medical Solutions
Radiology · 9d
Cleared Dec 19, 2003
T-TECH DIGITAL, MODEL WL-22XXA SERIES
K033857 · GZJ
Well-Life Healthcare, Inc.
Neurology · 8d
Cleared Dec 19, 2003
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
K033867 · LNH
General Electric Co.
Radiology · 7d
Cleared Dec 18, 2003
COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
K031618 · IPL
Comfort Orthopedic Co., Ltd.
Physical Medicine · 209d
Cleared Dec 18, 2003
TANGO, MODELS, BP1
K031711 · ITI
American Bantex Corp.
Physical Medicine · 199d
Cleared Dec 18, 2003
COMPRESS DISTAL FEMORAL REPLACEMENT
K031804 · KRO
Biomet, Inc.
Orthopedic · 190d
Cleared Dec 18, 2003
BTG SMARTEST GLUCOSE TEST SYSTEM
K032029 · NBW
Bt Medical
Chemistry · 170d
Cleared Dec 18, 2003
REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
K032973 · GDW
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 85d
Cleared Dec 18, 2003
AMI REPROCESSED MULTIPLE CLIP APPLIERS
K032980 · FZP
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 85d
Cleared Dec 18, 2003
VISU-LOCK 5MM CLIP APPLIER
K033161 · FZP
Gyrx, LLC
General & Plastic Surgery · 79d
Cleared Dec 18, 2003
EPW FOLDABLE POWER WHEELCHAIR, EPW-03
K033206 · ITI
Emg Technology Co., Ltd.
Physical Medicine · 77d
Cleared Dec 18, 2003
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
K033220 · INI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 76d
Cleared Dec 18, 2003
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
K033240 · INI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 73d
Cleared Dec 18, 2003
COAPT ENDOTINE CHIN 3.5 DEVICE
K033524 · HWC
Coapt Systems, Inc.
General & Plastic Surgery · 41d
Cleared Dec 18, 2003
FACTOR II (PROTHROMBIN) G20210A KIT
K033612 · NPR
Roche Diagnostics Corp.
Pathology · 31d
Cleared Dec 18, 2003
MODIFICATION TO UNITY NETWORK ID
K033672 · MWI
Ge Medical Systems Information...
Cardiovascular · 24d
Cleared Dec 18, 2003
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
K033709 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 22d
Cleared Dec 18, 2003
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
K033746 · GAM
Ethicon, Inc.
General & Plastic Surgery · 17d
Cleared Dec 18, 2003
MODIFICATION TO SLIM GLIDING NAIL SYSTEM
K033763 · KTT
Plus Orthopedics
Orthopedic · 16d
Cleared Dec 18, 2003
UB 140
K033827 · ITI
Rivertrail Mobility
Physical Medicine · 8d
Cleared Dec 17, 2003
PALACOS R BONE CEMENT WITH GENTAMICIN
K030086 · LOD
Biomet, Inc.
Orthopedic · 342d