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
73681–73704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2003
AURORA MR-GUIDED INTERVENTIONAL SYSTEM
K023686 · LNH
Aurora Imaging Technology, Inc.
Radiology · 89d
Cleared Jan 29, 2003
BICON TRANSITIONAL IMPLANT (BTI) SYSTEM
K023705 · DZE
Bicon, Inc.
Dental · 86d
Cleared Jan 29, 2003
DEVEX MESH SYSTEM
K023835 · MQP
Depuyacromed
Orthopedic · 72d
Cleared Jan 29, 2003
MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
K030049 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 23d
Cleared Jan 29, 2003
TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
K030191 · IYN
Teratech Corp.
Radiology · 8d
Cleared Jan 29, 2003
APEX 90
K030206 · EJT
We Dong Myung Dental Industrial Co.,...
Dental · 8d
Cleared Jan 28, 2003
BIOSORB RESORBABLE VOID FILLER
K021963 · MQV
Sciences ET Bio Materiaux (Sbm)
Orthopedic · 228d
Cleared Jan 28, 2003
SW-180 SHORTWAVE THERAPY UNIT
K022846 · IMJ
Ito Co., Ltd.
Physical Medicine · 154d
Cleared Jan 28, 2003
LFRE INDIRECT LARYNGOSCOPE
K023004 · EOB
Astralite Corp.
Ear, Nose, Throat · 141d
Cleared Jan 28, 2003
SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K023070 · ERL
Sodemsystems
Ear, Nose, Throat · 134d
Cleared Jan 28, 2003
GAS SAMPLING LINES
K023579 · CCK
Promedic, Inc.
Anesthesiology · 96d
Cleared Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
K023764 · JJE
Beckman Coulter, Inc.
Chemistry · 77d
Cleared Jan 28, 2003
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
K023802 · HRS
Synthes (Usa)
Orthopedic · 75d
Cleared Jan 28, 2003
PRECIMED HIP SCREW SYSTEM
K023851 · KTT
Precimed, Inc.
Orthopedic · 70d
Cleared Jan 28, 2003
ALUMINA V40 FEMORAL HEADS
K023901 · LZO
Howmedica Osteonics Corp.
Orthopedic · 67d
Cleared Jan 28, 2003
TRILUMINA THERAPEUTIC LASER SYSTEM
K023935 · NHN
Texas Applied Biomedical Services
Physical Medicine · 63d
Cleared Jan 28, 2003
DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K024081 · LYZ
Safehealth Medical Supply Corp.
General Hospital · 48d
Cleared Jan 28, 2003
NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
K024174 · LYZ
General Gloves Corp.
General Hospital · 41d
Cleared Jan 28, 2003
MONARCH SPINE SYSTEM
K024348 · MNH
Depuyacromed
Orthopedic · 29d
Cleared Jan 28, 2003
MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
K024373 · LGZ
Elltec Co., Ltd.
General Hospital · 28d
Cleared Jan 28, 2003
SOFT TISSUE ANCHORING WASHERS
K030031 · KGS
Accu-Speed, Incorporated
General & Plastic Surgery · 25d
Cleared Jan 28, 2003
VAXCEL WITH PASV PORT
K030083 · LJT
Boston Scientific Corp
General Hospital · 19d
Cleared Jan 28, 2003
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY...
K030150 · JJY
Cliniqa Corporation
Chemistry · 13d
Cleared Jan 27, 2003
ACIST GENTOO CONTRAST INJECTION SYSTEM
K020892 · DXT
Acist Medical Systems
Cardiovascular · 314d