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

Filters: Cleared only ×
176,076 results
61489–61512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2006
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
K061585 · DQE
Hospira, Inc.
Cardiovascular · 120d
Cleared Oct 05, 2006
VASORING* VRC VASCULAR RING CONNECTOR
K061626 · DSY
Sunwei Tech Co. , Ltd.
Cardiovascular · 115d
Cleared Oct 05, 2006
TREASURE
K061984 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 84d
Cleared Oct 05, 2006
ACCUSOFT, ACCUSOFT XL
K062032 · MUJ
Direx Systems Corp.
Radiology · 79d
Cleared Oct 05, 2006
ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES
K062047 · GEI
PAJUNK GmbH Medizintechnologie
General & Plastic Surgery · 77d
Cleared Oct 05, 2006
URASSIST
K062061 · NZU
Preferred Medical Devices, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 05, 2006
POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE
K062138 · LZA
Molnlycke Health Care, Inc.
General Hospital · 71d
Cleared Oct 05, 2006
MODULAR LAPAROSCOPY ACCESSORIES, HANDLE
K062337 · GEI
Aaron Medical Industries
General & Plastic Surgery · 56d
Cleared Oct 05, 2006
SYNGO DUAL ENERGY
K062351 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Oct 05, 2006
BRANSIST SAFIRE
K062360 · IZI
Shimadzu Corp.
Radiology · 52d
Cleared Oct 05, 2006
QANGIO CT
K062386 · JAK
Medis Medical Imaging Systems BV
Radiology · 51d
Cleared Oct 05, 2006
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
K062387 · PNO
Boston Scientific
Cardiovascular · 51d
Cleared Oct 05, 2006
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920...
K062516 · JNL
Beckman Coulter, Inc.
Immunology · 38d
Cleared Oct 05, 2006
BELMAX CM MODEL X168
K062529 · MUH
Takara Belmont USA, Inc.
Radiology · 37d
Cleared Oct 05, 2006
ECHELON SHOULDER COIL
K062556 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 36d
Cleared Oct 05, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML
K062680 · LON
Becton, Dickinson & CO
Microbiology · 27d
Cleared Oct 05, 2006
UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
K062686 · KWQ
Advanced Spine Technology, Inc.
Orthopedic · 27d
Cleared Oct 05, 2006
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
K062730 · HIS
Biogreen Medical Sdn. Bhd.
Obstetrics & Gynecology · 22d
Cleared Oct 05, 2006
DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP)
K062779 · GCJ
New Wave Surgical Corporation
General & Plastic Surgery · 17d
Cleared Oct 04, 2006
ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS
K061005 · DKZ
Applied Dna Technologies, Inc.
Toxicology · 176d
Cleared Oct 04, 2006
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
K061509 · LSL
Gen-Probe, Inc.
Microbiology · 125d
Cleared Oct 04, 2006
COULTER LH 780 HEMATOLOGY ANALYZER
K061616 · GKZ
Beckman Coulter, Inc.
Hematology · 118d
Cleared Oct 04, 2006
PREMIER SELF-ETCHING ENAMEL SEALANT
K061997 · EBC
Premier Dental Products Co.
Dental · 82d
Cleared Oct 04, 2006
PREMIER SELF-ETCHING BOND ENHANCER
K061998 · KLE
Premier Dental Products Co.
Dental · 82d