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
38209–38232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2014
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO...
K133912 · MQL
Origio A/S
Obstetrics & Gynecology · 142d
Cleared CT May 14, 2014
STOP U (PACKED BLACK USA)
K140255 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 103d
Cleared May 14, 2014
SALVATION OSTEOPENIC SCREW
K140408 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared May 14, 2014
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
K140591 · ONB
Becton, Dickinson & CO
General Hospital · 68d
Cleared May 14, 2014
MULTIFIX S KNOTLESS FIXATION SYSTEM
K140604 · MBI
ArthroCare Corporation
Orthopedic · 65d
Cleared May 14, 2014
MSP METATARSAL SHORTENING SYSTEM
K140724 · HRS
Nextremity Solutions, Inc.
Orthopedic · 54d
Cleared May 14, 2014
M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV...
K141010 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 26d
Cleared May 13, 2014
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC...
K130080 · JHY
Medica Corporation
Chemistry · 484d
Cleared May 13, 2014
EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)
K132899 · ONB
Equashield Medical , Ltd.
General Hospital · 239d
Cleared May 13, 2014
BIOMARC COAXIAL NEEDLE
K133148 · FBK
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 208d
Cleared May 13, 2014
Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM
K133206 · MUH
Zuma Dental, LLC
Radiology · 208d
Cleared May 13, 2014
VERSACUT + TISSUE MORCELLATOR
K133272 · GCJ
Lumenis, Ltd.
Obstetrics & Gynecology · 201d
Cleared May 13, 2014
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
K133317 · NRY
Penumbra, Inc.
Neurology · 197d
Cleared May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR
K140056 · MQB
Rayence Co., Ltd.
Radiology · 123d
Cleared May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
K140060 · MQB
Rayence Co., Ltd.
Radiology · 123d
Cleared May 13, 2014
IMDX HSV-1/2 FOR ABBOTT M2000
K140198 · OQO
Intelligent Medical Devices, Inc.
Microbiology · 106d
Cleared May 13, 2014
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN,...
K140343 · MPN
Aesculap, Inc.
General & Plastic Surgery · 91d
Cleared May 13, 2014
VITREA IMAGE DENOISING SOFTWARE
K140395 · LLZ
Vital Images, Inc.
Radiology · 84d
Cleared May 13, 2014
CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT
K140568 · FMI
Facet Technologies, LLC
General Hospital · 69d
Cleared May 13, 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622 · HRS
Biomet, Inc.
Orthopedic · 63d
Cleared May 13, 2014
ONE-PIECE PEEK FUSION IMPLANT
K140970 · HWC
Mtp Solutions, LLC
Orthopedic · 27d
Cleared May 12, 2014
ROSS RU SKIN DISCONTINUITIES
K131176 · FRO
Biotd S.A.
General & Plastic Surgery · 382d
Cleared May 12, 2014
TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT...
K131531 · MEG
Anhui Tiankang Medical Products Co.,...
General Hospital · 349d
Cleared May 12, 2014
GALLIEON-1 MEDICAL LASER
K132529 · ILY
Future Device and Technology, Inc.
Physical Medicine · 273d