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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
66433–66456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2005
XP TECHNOLOGY ULTRASONIC SCALER
K042972 · ELC
American Eagle Instruments, Inc.
Dental · 141d
Cleared Mar 18, 2005
OMNILUX REVIVE AND BLUE
K043329 · GEX
Photo Therapeutics Limited
General & Plastic Surgery · 106d
Cleared Mar 18, 2005
CRYOCHECK CLOT S
K043571 · GGP
Precision Biologic, Inc.
Hematology · 81d
Cleared Mar 18, 2005
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K050021 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 72d
Cleared Mar 18, 2005
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
K050125 · JJY
More Diagnostics
Toxicology · 58d
Cleared Mar 18, 2005
TEMPTOUCH DERMAL THERMOMETER
K050137 · FLL
Xilas Medical, Inc.
General Hospital · 53d
Cleared Mar 18, 2005
AEU-14CF EXPENDITION
K050201 · EIA
Aseptico, Inc.
Dental · 49d
Cleared Mar 18, 2005
STARSHIELD V3 RF TRNT
K050237 · LNH
Odin Medical Technologies , Ltd.
Radiology · 44d
Cleared Mar 18, 2005
FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND:...
K050293 · GEX
Fotona D.D.
General & Plastic Surgery · 39d
Cleared Mar 18, 2005
550 TXT TREATMENT TABLE
K050422 · JAI
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Mar 18, 2005
TEMPOSIL, MODEL 6720
K050426 · EMA
Coltene/Whaledent AG
Dental · 28d
Cleared Mar 18, 2005
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200...
K050527 · LYY
Spi Gloves Sdn. Bhd.
General Hospital · 16d
Cleared Mar 18, 2005
POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE)
K050531 · LZA
Spi Gloves Sdn. Bhd.
General Hospital · 16d
Cleared Mar 18, 2005
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
K050585 · LRG
Dade Behring, Inc.
Microbiology · 11d
Cleared Mar 17, 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
K040262 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 407d
Cleared Mar 17, 2005
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
K043436 · FKR
Nxstage Medical, Inc.
Gastroenterology & Urology · 94d
Cleared Mar 17, 2005
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA
K043451 · GGN
Hyphen Biomed
Hematology · 93d
Cleared Mar 17, 2005
COSMAN RF LESION GENERATOR, MODEL RFG-1A
K050084 · GXI
Cosman Medical, Inc.
Neurology · 63d
Cleared Mar 17, 2005
V-BAG WITH GBS COATING
K050195 · DTN
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Mar 17, 2005
PERSONAL WARMING GEL
K050211 · NUC
Qualis, Inc.
Obstetrics & Gynecology · 45d
Cleared Mar 17, 2005
PERSONAL WARMING JELLY
K050212 · NUC
Qualis, Inc.
Obstetrics & Gynecology · 45d
Cleared Mar 17, 2005
ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
K050255 · EHD
Gendex Dental Systems
Radiology · 42d
Cleared Mar 17, 2005
STABILIZATION SCREW
K050346 · HWC
New Deal, S.A.
Orthopedic · 34d
Cleared Mar 17, 2005
IMAGENPRO
K050366 · KPS
Cardiovascular Imaging Technologies, LLC
Radiology · 31d