FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94729–94752 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1997
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
K962723 · LBR
Trace America, Inc.
Chemistry · 241d
Cleared Mar 13, 1997
NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM
K962791 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 239d
Cleared Mar 13, 1997
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
K963174 · DSH
Del Mar Avionics
Cardiovascular · 211d
Cleared Mar 13, 1997
SYSMEX SE/RAM-1
K964375 · GKL
Sysmex Corp.
Hematology · 132d
Cleared Mar 13, 1997
IMPLEX REPLACEMENT ACETABULAR CUP INSERT
K964882 · LPH
Implex Corp.
Orthopedic · 98d
Cleared Mar 13, 1997
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145 · KWP
Depuy, Inc.
Orthopedic · 80d
Cleared Mar 13, 1997
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
K965164 · LPH
Howmedica Corp.
Orthopedic · 79d
Cleared Mar 13, 1997
HOWMEDICA MAINSTAY ANCHOR
K965175 · JDR
Howmedica Corp.
Orthopedic · 79d
Cleared Mar 13, 1997
BIORIGID NAIL TIBIA
K970013 · HTY
Aap GmbH and Co. Betriebs KG
Orthopedic · 70d
Cleared Mar 13, 1997
LINK CERCLAGE WIRE SYSTEM
K970084 · JDQ
Turnkey Intergration USA, Inc.
Orthopedic · 63d
Cleared Mar 13, 1997
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K970097 · JDW
Synthes (Usa)
Orthopedic · 59d
Cleared Mar 13, 1997
PERSONAL CATHETER
K970704 · GBM
Rochester Medical Corp.
Gastroenterology & Urology · 15d
Cleared Mar 12, 1997
CONTRAST MEDIA SET
K955179 · IZI
B.Braun Medical, Inc.
Radiology · 485d
Cleared Mar 12, 1997
MS-2000
K961144 · DXN
Touritu Engineering Co., Inc.
Cardiovascular · 356d
Cleared Mar 12, 1997
PROTIME MICROCOAGULATION SYSTEM
K961835 · GJS
International Technidyne Corp.
Hematology · 303d
Cleared Mar 12, 1997
HEARTPORT NEEDLE TROCAR
K965051 · DRC
Heartport, Inc.
Cardiovascular · 84d
Cleared Mar 12, 1997
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
K965161 · LMD
Sectra-Imtec AB
Radiology · 79d
Cleared Mar 12, 1997
RFG-3CF
K965182 · GXD
Radionics, Inc.
Neurology · 78d
Cleared Mar 12, 1997
WIDEX MODEL SENSO DIGITAL (C9)
K965254 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 72d
Cleared Mar 12, 1997
TARGOGRID
K970037 · LNH
Daum GmbH
Radiology · 65d
Cleared Mar 12, 1997
INTEGRATED VISUALIZATION SYSTEM
K970598 · FCW
Urohealth, Inc.
Gastroenterology & Urology · 22d
Cleared Mar 11, 1997
SLEEP SYSTEM FOR CLINICS & RESEARCH
K955841 · MNR
Compumedics Ptd , Ltd.
Anesthesiology · 445d
Cleared Mar 11, 1997
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
K961707 · BSY
Sorenson Critical Care
Anesthesiology · 313d
Cleared Mar 11, 1997
PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)
K962605 · FRG
Surgicot, Inc.
General Hospital · 252d