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
48409–48432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2011
CERSR ELECTROMYOGRAPHY SYSTEM
K110048 · IKN
Spinematrix, Inc.
Neurology · 20d
Cleared Jan 26, 2011
VANTAGE VIEW SYSTEM
K110085 · DXJ
St Jude Medical
Cardiovascular · 15d
Cleared CT Jan 25, 2011
SURECALL EMG LABOR MONITOR
K090145 · OSP
Reproductive Research Technologies, LP
Obstetrics & Gynecology · 734d
Cleared Jan 25, 2011
ORAL FLUID PHENCYCLIDINE
K093989 · LCM
Roche Diagnostics
Chemistry · 397d
Cleared Jan 25, 2011
FLUORCANASITE DENTAL CERAMIC
K100794 · EIH
Dr Sarah Pollington
Dental · 309d
Cleared Jan 25, 2011
CEROX, MODEL 321OF
K100875 · MUD
Or-Nim Medical , Ltd.
Cardiovascular · 301d
Cleared Jan 25, 2011
ORTHOVITA PEEK SPACER
K101171 · ODP
Orthovita, Inc.
Orthopedic · 274d
Cleared Jan 25, 2011
PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC...
K101225 · DZE
Promimic AB
Dental · 267d
Cleared Jan 25, 2011
DIATRON PICTUS 400
K101741 · CGA
Diatron Group
Chemistry · 217d
Cleared Jan 25, 2011
ORTHODONTIC CERAMIC BRACKET
K102561 · NJM
Ht Co., Ltd.
Dental · 140d
Cleared Jan 25, 2011
TIGER FLAT SURGICAL MASK
K102713 · FXX
Tiger Medical Products, Ltd.
General Hospital · 127d
Cleared Jan 25, 2011
FLAMENCO SPINAL FIXATION SYSTEM
K102853 · MNH
Ulrich GmbH & Co. KG
Orthopedic · 118d
Cleared Jan 25, 2011
CHEETAH RELIANT
K103166 · DSB
Cheetah Medical, Inc.
Cardiovascular · 90d
Cleared Jan 25, 2011
MSC LIPID CONTROL
K103271 · JJY
Maine Standards Co.
Chemistry · 81d
Cleared Jan 25, 2011
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
K103450 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 62d
Cleared Jan 25, 2011
LITECURE THERAPY SYSTEM
K103511 · ILY
Litecure, LLC
Physical Medicine · 56d
Cleared Jan 25, 2011
DIMENSION VISA ENZ 2 CAL
K103612 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 47d
Cleared Jan 25, 2011
PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER
K103616 · IYE
Aktina Medical Physics Corp.
Radiology · 46d
Cleared Jan 25, 2011
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES...
K103805 · LIO
Medical Wire & Equipment Company...
Microbiology · 28d
Cleared Jan 25, 2011
Q-STATION
K103815 · LLZ
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Jan 24, 2011
SORBACT
K100591 · FRO
Abigo Medical AB
General & Plastic Surgery · 328d
Cleared Jan 24, 2011
WOUND PRO APEX
K100823 · OMP
Accuro Medical Products, LLC
General & Plastic Surgery · 306d
Cleared Jan 24, 2011
VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V,...
K101604 · DYB
Vascular Solutions, Inc.
Cardiovascular · 230d
Cleared Jan 24, 2011
VIZION DR
K102123 · KPR
Viztek, Inc.
Radiology · 179d