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
42577–42600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2012
NIXALL TM WOUND AND SKIN CARE
K113693 · FRO
Seriously Clean, Ltd.
General & Plastic Surgery · 361d
Cleared Dec 11, 2012
QUARK SERIES
K120146 · CBK
Cosmed Srl
Anesthesiology · 328d
Cleared Dec 11, 2012
BPA-FREE MICROHYBID COMPOSITE
K120237 · EBF
Novocol, Inc.
Dental · 320d
Cleared Dec 11, 2012
NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
K120356 · MBI
Ncs Lab Srl
Orthopedic · 309d
Cleared Dec 11, 2012
AMBIENT TURBOFLASH 90 IFS
K120791 · GEI
Arthocare Corporation
General & Plastic Surgery · 271d
Cleared Dec 11, 2012
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K120866 · NBW
Delbio Incorporation
Chemistry · 264d
Cleared Dec 11, 2012
CARDIOSCOPE
K121266 · DXN
Pulsecor Limited
Cardiovascular · 229d
Cleared Dec 11, 2012
ULTRASONIC SURGERY
K121620 · DZI
Dmetec.Co., Ltd.
Dental · 193d
Cleared Dec 11, 2012
NP-CAST ABUTMENT SYSTEM
K121843 · NHA
Osstem Implant Co., Ltd.
Dental · 169d
Cleared Dec 11, 2012
PBP TOTAL HIP SYSTEM
K122158 · OQG
Pipeline Biomedical Products, LLC
Orthopedic · 144d
Cleared Dec 11, 2012
ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS
K122268 · NHA
Dentsply International
Dental · 134d
Cleared Dec 11, 2012
TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE...
K122421 · EJK
Kuraray Noritake Dental, Inc.
Dental · 124d
Cleared Dec 11, 2012
MTA2 ROOT AND PULP MATERIALS
K122892 · KIF
Avalon Biomed, Inc.
Dental · 82d
Cleared Dec 11, 2012
GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM*...
K122980 · DYB
Terumo Medical Corporation
Cardiovascular · 76d
Cleared Dec 11, 2012
L.A.M. IMP WOUND GEL
K123113 · FRO
Glycobiosciences, Inc.
General & Plastic Surgery · 69d
Cleared Dec 11, 2012
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
K123317 · FDS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 47d
Cleared Dec 11, 2012
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
K123479 · FTL
Sofradim Production
General & Plastic Surgery · 28d
Cleared Dec 10, 2012
CARDNAV
K120282 · OWB
Paieon, Inc.
Radiology · 314d
Cleared Dec 10, 2012
PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
K120953 · CAC
Tlelflex Medical, Inc.
Anesthesiology · 255d
Cleared Dec 10, 2012
INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS
K121391 · NHA
Prismatik Dentalcraft, Inc.
Dental · 215d
Cleared Dec 10, 2012
OP300
K122018 · OAS
Palodex Group OY
Radiology · 153d
Cleared Dec 10, 2012
EMERGE MEDICAL SOLID BONE SCREWS
K122489 · HWC
Emerge Medical
Orthopedic · 117d
Cleared Dec 10, 2012
JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP...
K122740 · OCX
Jetprep, Ltd.
Gastroenterology & Urology · 95d
Cleared Dec 10, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K122828 · LYZ
Shandong Hongxin Chemicals Co., Ltd.
General Hospital · 84d