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
82849–82872 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2000
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044,...
K991818 · FRO
Acrymed, Inc.
General & Plastic Surgery · 326d
Cleared Apr 17, 2000
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
K991908 · FJI
Idemsa
Gastroenterology & Urology · 315d
Cleared Apr 17, 2000
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
K993677 · DWF
Medtronic Vascular
Cardiovascular · 168d
Cleared Apr 17, 2000
SUTUREGROOVE
K994289 · MML
Iop, Inc.
Ophthalmic · 118d
Cleared Apr 14, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO...
K000126 · DQA
Masimo Corp.
Anesthesiology · 87d
Cleared Apr 14, 2000
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
K000223 · LZA
Phoenix Medical Technology, Inc.
General Hospital · 81d
Cleared Apr 14, 2000
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
K000238 · LGC
Mrl Diagnostics
Microbiology · 78d
Cleared Apr 14, 2000
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
K000241 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 78d
Cleared Apr 14, 2000
LAZERSMILE, LAZERWHITE
K000290 · EFW
Biolase Technology, Inc.
Dental · 74d
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