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
84145–84168 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1999
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL
K993413 · ITI
Invacare Corp.
Physical Medicine · 64d
Cleared Dec 15, 1999
BACT/ALERT SA
K993423 · MDB
Organon Teknika Corp.
Microbiology · 64d
Cleared Dec 15, 1999
SYSTEM 2100
K993530 · LLZ
Math Solutions, LLC
Radiology · 58d
Cleared Dec 15, 1999
DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST...
K993532 · LLZ
Impax Technology, Inc.
Radiology · 57d
Cleared Dec 15, 1999
DCI ENDOSCOPE
K993539 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 57d
Cleared Dec 15, 1999
CONFORMAX MMLC VR1
K993594 · IYE
Radionics, Inc.
Radiology · 51d
Cleared Dec 15, 1999
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
K993597 · LMA
Vidar Systems Corp.
Radiology · 51d
Cleared Dec 15, 1999
PRE-VISION FILL
K993602 · EBF
Heraeus Kulzer, Inc.
Dental · 51d
Cleared Dec 15, 1999
OMNISONICS ULTRASONIC PROBES
K993628 · LFL
Omnisonics Medical Technologies
General & Plastic Surgery · 49d
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