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
83641–83664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1999
AED CYSTOSCOPE
K993689 · FAJ
National Advanced Endoscopy Devices,...
Gastroenterology & Urology · 44d
Cleared Dec 15, 1999
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K993855 · KWQ
Danek Medical, Inc.
Orthopedic · 30d
Cleared Dec 14, 1999
SIMPLIFY D-DIMER, MODEL DCGK1
K993276 · GHH
Agen Biomedical , Ltd.
Hematology · 75d
Cleared Dec 14, 1999
BACT/ALERT SN
K993421 · MDB
Organon Teknika Corp.
Microbiology · 63d
Cleared Dec 14, 1999
BACT/ALERT MP PROCESS BOTTLE
K993576 · MDB
Organon Teknika Corp.
Microbiology · 54d
Cleared Dec 14, 1999
EBI XFIX VISION FIXATION SYSTEM
K993886 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Dec 13, 1999
MENTOR EVACARE VAGINAL PESSARIES
K993308 · HHW
Mentor Corp.
Obstetrics & Gynecology · 70d
Cleared Dec 13, 1999
CERADIUM V NON-PRECIOUS CERAMIC ALLOY
K993572 · EJH
Matech, Inc.
Dental · 53d
Cleared Dec 13, 1999
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
K993680 · LYZ
Top Glove Sdn. Bhd.
General Hospital · 42d
Cleared Dec 13, 1999
PULPDENT UNO-DUO
K993683 · KLE
Pulpdent Corp.
Dental · 42d
Cleared Dec 13, 1999
TETRIC FLOW
K993783 · EBF
Ivoclar North America, Inc.
Dental · 35d
Cleared Dec 12, 1999
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
K983250 · DSK
Magnetic Resonance Equipment Corp.
Cardiovascular · 452d
Cleared Dec 10, 1999
ACTIFRESH 400 LENS
K983637 · LPL
Hydron , Ltd.
Ophthalmic · 420d
Cleared Dec 10, 1999
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
K990308 · FOZ
Rocap Div. of Sabratek Corp.
General Hospital · 312d
Cleared Dec 10, 1999
HEPARIN IV FLUSH SYRINGE, 10 U/ML \
K990390 · FOZ
Rocap Div. of Sabratek Corp.
General Hospital · 304d
Cleared Dec 10, 1999
DRUG STOP
K991465 · MVO
Texas Immunology, Inc.
Toxicology · 227d
Cleared Dec 10, 1999
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
K991714 · DQD
Doctor'S Research Group, Inc.
Cardiovascular · 204d
Cleared Dec 10, 1999
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
K991756 · DQD
Bio-Research Associates, Inc.
Cardiovascular · 200d
Cleared Dec 10, 1999
LUMA-CATH STEERABLE EP CATHETERS
K991878 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 191d
Cleared Dec 10, 1999
CUSTODIOL
K992209 · KDN
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 163d
Cleared Dec 10, 1999
VIT ENHANCER
K992943 · HQE
Medical Instrument Development...
Ophthalmic · 101d
Cleared Dec 10, 1999
CHEST DRAINAGE TUBING
K993062 · DWE
Olson Medical Sales, Inc.
Cardiovascular · 88d
Cleared Dec 10, 1999
SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
K993072 · MKJ
Survivalink Corp.
Cardiovascular · 87d
Cleared Dec 10, 1999
SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525
K993074 · MAI
Bionx Implants, Ltd.
Orthopedic · 87d