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

Filters: Cleared only ×
175,820 results
53017–53040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2009
NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100
K091096 · EIH
Dental Solutions, Inc.
Dental · 63d
Cleared Jun 18, 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K091126 · LON
bioMerieux, Inc.
Microbiology · 59d
Cleared Jun 18, 2009
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS...
K091449 · DSP
Datascope Corp., Cardiac Assist Division
Cardiovascular · 31d
Cleared Jun 18, 2009
TREVAIR CHAIR
K091478 · IOR
Patmont Motor Werks, Inc.
Physical Medicine · 30d
Cleared Jun 18, 2009
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K091492 · MUJ
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Jun 18, 2009
CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM
K091518 · IYO
Mcube Technology Co., Ltd.
Radiology · 27d
Cleared Jun 18, 2009
MUCHECK V8
K091602 · IYE
Oncology Data Systems, Inc.
Radiology · 15d
Cleared Jun 18, 2009
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III
K091669 · LNH
Xioao Mdt Technology Co, Ltd.
Radiology · 9d
Cleared Jun 17, 2009
DUAL SYRINGE HOLDER
K082110 · FMG
Surgin Surgical Instrumentation, Inc.
General Hospital · 324d
Cleared Jun 17, 2009
CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES
K082910 · FRO
Aso, LLC
General & Plastic Surgery · 260d
Cleared Jun 17, 2009
TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
K090180 · DRX
Vermed, Inc.
Cardiovascular · 145d
Cleared Jun 17, 2009
SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
K090241 · HSB
Synthes (Usa)
Orthopedic · 135d
Cleared Jun 17, 2009
LUCAS 2
K090422 · DRM
Jolife AB
Cardiovascular · 119d
Cleared Jun 17, 2009
MULTILINK IMPLANT
K090704 · EBF
Ivoclar Vivadent, Inc.
Dental · 92d
Cleared Jun 17, 2009
COCHLEAR BAHA BP100
K090720 · LXB
Cochlear Bone Anchored Systems AB
Ear, Nose, Throat · 91d
Cleared Jun 17, 2009
RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
K090763 · NPJ
Mako Surgical Corporation
Orthopedic · 86d
Cleared Jun 17, 2009
STRATAPULSE TS AND STRATAPULSE
K090837 · ONF
Advanced Medical Photonics
General & Plastic Surgery · 82d
Cleared Jun 17, 2009
AMARIS GINGIVA OPAQUER
K090843 · EBF
Voco GmbH
Dental · 82d
Cleared Jun 17, 2009
PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM
K090848 · FQH
Premier Brands of America, Inc.
General & Plastic Surgery · 79d
Cleared Jun 17, 2009
EQUIA
K091106 · EMA
GC America, Inc.
Dental · 62d
Cleared Jun 17, 2009
4D INTEGRATED TREATMENT CONSOLE
K091132 · IYE
Varian Medical Systems
Radiology · 58d
Cleared Jun 17, 2009
COSTORSOL
K091245 · KDN
Preservation Solutions, Inc.
Gastroenterology & Urology · 50d
Cleared Jun 17, 2009
1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
K091466 · LJS
Medcomp
General Hospital · 30d
Cleared Jun 17, 2009
MAGNUM MP FIXATION DEVICE
K091503 · MBI
Arthrocare Corp.
Orthopedic · 27d