FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
82345–82368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2000
EZ CONNECT
K000346 · EBG
Kerr Dental Materials Center
Dental · 71d
Cleared Apr 14, 2000
FIXATION STYLETS, MODELS 335-287 AND 335-288
K000366 · DRB
Accufix Research Institute
Cardiovascular · 70d
Cleared Apr 14, 2000
939UDX URINE PATHOLOGY SYSTEM
K000373 · LKM
Intl. Remote Imaging Systems
Pathology · 70d
Cleared Apr 14, 2000
CHILI VIDEO, CHILI VIDEOPRO
K000411 · LMA
Steinbeis-Transferzentrum...
Radiology · 66d
Cleared Apr 14, 2000
INTERVENTIONAL BODY COIL
K000437 · MOS
Usa Instruments, Inc.
Radiology · 64d
Cleared Apr 14, 2000
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
K000460 · DKZ
Dade Behring, Inc.
Toxicology · 63d
Cleared Apr 14, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
K000464 · DJG
Dade Behring, Inc.
Toxicology · 63d
Cleared Apr 14, 2000
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000467 · DIO
Dade Behring, Inc.
Toxicology · 63d
Cleared Apr 14, 2000
ABC CERVICAL PLATING SYSTEM
K000486 · KWQ
Aesculap, Inc.
Orthopedic · 60d
Cleared Apr 14, 2000
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
K000494 · LDP
Beckman Coulter, Inc.
Toxicology · 59d
Cleared Apr 14, 2000
SYNTHES (USA) WRIST FUSION PLATES (WFP)
K000558 · LXT
Synthes (Usa)
Orthopedic · 56d
Cleared Apr 14, 2000
PRODIGY LATERAL VIEW SOFTWARE
K000826 · KGI
Lunar Corp.
Radiology · 31d
Cleared Apr 14, 2000
INTRASTENT DOUBLESTRUT XS STENT
K000864 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 14, 2000
EEG WITH VIDEO, MODEL EX-NW
K000898 · GWQ
Excel Tech. , Ltd.
Neurology · 24d
Cleared Apr 14, 2000
MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057
K000911 · GEI
Hysterx, Inc.
General & Plastic Surgery · 24d
Cleared Apr 14, 2000
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
K000971 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 18d
Cleared Apr 14, 2000
AGILITY STEERABLE GUIDEWIRE
K001033 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 14d
Cleared Apr 14, 2000
MODIFICATION TO EBI SPINELINK SYSTEM
K001037 · MNI
Ebi, L.P.
Orthopedic · 14d
Cleared Apr 14, 2000
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991519 · FIP
Ameriwater
Gastroenterology & Urology · 350d
Cleared Apr 14, 2000
SONADA ULTRASOUND SYSTEM
K993092 · OXO
Sonovision Corp.
Radiology · 211d
Cleared Apr 14, 2000
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS
K993489 · LPL
Crystal Reflections, Int., Inc.
Ophthalmic · 182d
Cleared Apr 14, 2000
HAIDER-UCR SPINAL SYSTEM
K993503 · MNH
International Advanced Medical...
Orthopedic · 182d
Cleared Apr 14, 2000
TENAX WHITE POST
K993545 · ELR
Coltene/Whaledent, Inc.
Dental · 178d
Cleared Apr 14, 2000
APPRAISE-CARDIO SAMPLE COLLECTION KIT
K993787 · JKA
Osborn Group, Inc.
Chemistry · 157d