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
48313–48336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2011
NUVUE COLORMARK9TM) NEEDLE
K101312 · IYN
Nuvue Therapeutics, Inc.
Radiology · 269d
Cleared Feb 04, 2011
GOLDEN GATE ANTERIOR PLATE SYSTEM
K101353 · KWQ
Ulrich GmbH & Co. KG
Orthopedic · 266d
Cleared Feb 04, 2011
NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
K101392 · KQP
Astoria-Pacific, Inc.
Chemistry · 262d
Cleared Feb 04, 2011
STEREOS WORKSTATION
K101398 · LLZ
Biospace Med
Radiology · 262d
Cleared Feb 04, 2011
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
K101673 · JIL
Teco Diagnostics
Chemistry · 234d
Cleared Feb 04, 2011
5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
K101743 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 227d
Cleared Feb 04, 2011
ACIES
K101842 · LLZ
Konica Minolta Medical & Graphic, Inc.
Radiology · 218d
Cleared Feb 04, 2011
MH1 MICROHOLTER RECORDER
K101969 · MWJ
Exelys, LLC
Cardiovascular · 206d
Cleared Feb 04, 2011
TURBO TEMP 3
K102753 · EBG
Danville Materials, Inc.
Dental · 134d
Cleared Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
K103403 · JIX
Abbott Laboratories
Chemistry · 77d
Cleared Feb 04, 2011
AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
K103516 · DQD
Inovise Medical, Inc.
Cardiovascular · 66d
Cleared Feb 04, 2011
VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE
K103707 · GEI
Vectec
General & Plastic Surgery · 46d
Cleared Feb 04, 2011
SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
K103732 · DXN
Spacelabs Healthcare, Ltd.
Cardiovascular · 44d
Cleared Feb 04, 2011
MOBILE MIM
K103785 · LLZ
Mim Software, Inc.
Radiology · 39d
Cleared Feb 04, 2011
COHESION BONE CEMENT
K103816 · NDN
Teknimed Sas
Orthopedic · 37d
Cleared Feb 04, 2011
BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
K110104 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 22d
Cleared Feb 04, 2011
FETAL DOPPLER JPD-100S
K110124 · KNG
Shenzhen Jumper Medical Equipment...
Radiology · 17d
Cleared Feb 03, 2011
FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
K070049 · ONW
Fresenius Medical Care North America
Gastroenterology & Urology · 1491d
Cleared Feb 03, 2011
MONICA AN24
K101801 · OSP
Monica Healthcare
Obstetrics & Gynecology · 220d
Cleared Feb 03, 2011
BALL ABUTMENT SYSTEM
K101890 · NHA
Megagen Co., Ltd.
Dental · 211d
Cleared Feb 03, 2011
BUTLER CALCI-FLOR PROPHYLAXIS PASTE
K102053 · EJR
Sunstar Americas, Inc.
Dental · 196d
Cleared Feb 03, 2011
SUTRAZORB
K102592 · GAM
Visionary Medical Supplies, Inc.
General & Plastic Surgery · 147d
Cleared Feb 03, 2011
NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC...
K102652 · FYA
Gri Medical & Electronic Technology...
General Hospital · 142d
Cleared Feb 03, 2011
PATIENT EXAMINATION GLOVES
K102838 · LYY
Thai Hua Holding Co., Ltd.
General Hospital · 127d