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
43393–43416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2012
TENS BACK PAIN RELIEF SYSTEM
K113321 · NUH
Savia Limited
Neurology · 299d
Cleared Sep 04, 2012
ORTHOFIX GALAXY FIXATION SYSTEM
K113770 · KTT
Orthofix Srl
Orthopedic · 257d
Cleared Sep 04, 2012
CVINSIGHT
K120052 · DQA
Intelomed, Inc.
Anesthesiology · 242d
Cleared Sep 04, 2012
IOI TOTAL HIP
K121034 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 152d
Cleared Sep 04, 2012
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
K122042 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 54d
Cleared Sep 04, 2012
ALAMO P
K122047 · MAX
Alliance Partners, LLC
Orthopedic · 54d
Cleared Sep 04, 2012
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE...
K122155 · MUH
VATECH Co., Ltd.
Radiology · 46d
Cleared Sep 04, 2012
ARC ENDOCUFF
K122565 · FED
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 13d
Cleared Aug 31, 2012
DACRYOCATH
K113508 · OKS
Armadillo Biomedical, LLC
Ophthalmic · 277d
Cleared Aug 31, 2012
PINTLER PATIENT WARMING SYSTEM
K113705 · DWJ
Pintler Medical
Cardiovascular · 259d
Cleared Aug 31, 2012
STALIF C
K120819 · OVE
Centinel Spine, Inc.
Orthopedic · 165d
Cleared Aug 31, 2012
FLEXLAB 3.6, ACCELERATOR A3600
K121012 · CEM
Inpeco S.P.A.
Chemistry · 150d
Cleared Aug 31, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
K121196 · LOX
Boston Scientific Corp
Cardiovascular · 134d
Cleared Aug 31, 2012
DISPOSABLE HEMOSTASIS CHIP
K121505 · PKL
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 102d
Cleared Aug 31, 2012
TYSHAK NUCLEUS
K121859 · DQY
NuMED, Inc.
Cardiovascular · 66d
Cleared Aug 31, 2012
THERMO SCIENTIFIC MAS OMNI-CARDIO
K122291 · JJY
Microgenics Corporation
Chemistry · 31d
Cleared Aug 30, 2012
SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200...
K113291 · OMP
Simex Medizintechnik GmbH
General & Plastic Surgery · 296d
Cleared Aug 30, 2012
PRECISE SHP DIODE LASER
K113472 · GEX
CAO Group, Inc.
General & Plastic Surgery · 282d
Cleared Aug 30, 2012
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF...
K113652 · HRS
Aap Implantate AG
Orthopedic · 262d
Cleared Aug 30, 2012
ZIMMER DENTAL TAPERED SCREW-VENT X
K113753 · DZE
Zimmer Dental, Inc.
Dental · 253d
Cleared Aug 30, 2012
VANTERA CLINICAL ANALYZER
K113830 · CDT
Liposcience
Chemistry · 247d
Cleared Aug 30, 2012
SMARTLYTE ELECTROLYTE ANALYZER
K121040 · CEM
Diamond Diagnostics, Inc.
Chemistry · 147d
Cleared Aug 30, 2012
THIXO-GEL ULTRASOUND SPRAY
K121311 · MUI
Cloverline International Pharma...
Radiology · 121d
Cleared Aug 30, 2012
DTAD
K121678 · ERL
Gyrus Acmi, Inc.
Ear, Nose, Throat · 84d