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
49609–49632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2010
ASCENSION MODULAR TOTAL SHOULDER SYSTEM
K100448 · KWS
Ascension Orthopedics, Inc.
Orthopedic · 194d
Cleared Aug 30, 2010
1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1
K100998 · MEG
Unilife Medical Solutions Limited
General Hospital · 140d
Cleared Aug 30, 2010
TEPHAFLEX COMPOSITE MESH
K101287 · OWT
Tepha, Inc.
General & Plastic Surgery · 115d
Cleared Aug 30, 2010
3DHJD CAMERA SYSTEM MODEL
K101810 · GCJ
Vision Systems Group, A Division of...
General & Plastic Surgery · 62d
Cleared Aug 30, 2010
CYBERWAND LITHOTRIPTER
K102169 · FFK
Cybersonics, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 27, 2010
FS ALIGNER
K093821 · NXC
Allesee Orthodontic Appliances
Dental · 256d
Cleared Aug 27, 2010
QUASAR BLUE LIGHT THERAPY SYSTEM
K093963 · OLP
Silver Bay, LLC
General & Plastic Surgery · 247d
Cleared Aug 27, 2010
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
K100141 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 220d
Cleared Aug 27, 2010
ST AIA PACK HBA1C
K100304 · LCP
Tosoh Bioscience, Inc.
Chemistry · 205d
Cleared Aug 27, 2010
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229
K100367 · MQL
Origio A/S
Obstetrics & Gynecology · 196d
Cleared Aug 27, 2010
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6
K100622 · FLE
Belimed Sauter AG
General Hospital · 176d
Cleared Aug 27, 2010
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER...
K100635 · LJS
Arrow Intl., Inc.
General Hospital · 175d
Cleared Aug 27, 2010
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP...
K100763 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 163d
Cleared Aug 27, 2010
ACCU-CHEK ULTRFLEX INFUSION SET
K101196 · FPA
Roche Diagnostics Corp.
General Hospital · 120d
Cleared Aug 27, 2010
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,...
K101199 · KNT
Maquet Critical Care AB
Gastroenterology & Urology · 120d
Cleared Aug 27, 2010
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS,...
K101330 · JOW
Midwest Reprocessing Center, LLC
Cardiovascular · 107d
Cleared Aug 27, 2010
TX1 TISSUE REMOVAL SYSTEM
K101561 · LFL
American Optisurgical, Inc.
General & Plastic Surgery · 84d
Cleared Aug 27, 2010
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
K101633 · JJY
Nova Biomedical Corp.
Chemistry · 78d
Cleared Aug 27, 2010
MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
K101702 · JOW
Midwest Reprocessing Center, LLC
Cardiovascular · 71d
Cleared Aug 27, 2010
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
K101832 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 57d
Cleared Aug 27, 2010
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
K101889 · ITH
Pivotal Health Solutions
Physical Medicine · 51d
Cleared Aug 27, 2010
HEINE GAMMA G7
K101892 · DXQ
Heine Optotechnik GmbH & Co. KG
Cardiovascular · 51d
Cleared Aug 27, 2010
SUR-G GLOV AND MAXITEX
K102119 · KGO
Terang Nusa Sdn Bhd
General Hospital · 30d
Cleared Aug 27, 2010
ENDOTRACHEAL TUBE CHANGERS
K102127 · LNZ
Instrumentation Industries, Inc.
Anesthesiology · 29d