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
87097–87120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1998
OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM...
K983568 · LYY
Contract Latex Dippers Sdn Bhd
General Hospital · 69d
Cleared Dec 21, 1998
GIFT CATHETER SET/S
K983590 · MQF
Cook Ob/Gyn
Obstetrics & Gynecology · 69d
Cleared Dec 21, 1998
INTRATUBAL TRANSFER SETS
K983591 · MQF
Cook Ob/Gyn
Obstetrics & Gynecology · 69d
Cleared Dec 21, 1998
EMBRYO TRANSFER CATHETERS/SETS
K983594 · MQF
Cook Ob/Gyn
Obstetrics & Gynecology · 69d
Cleared Dec 21, 1998
SYNCHRON SYSTEMS LIPID CALIBRATOR
K983640 · JIS
Beckman Coulter, Inc.
Chemistry · 66d
Cleared Dec 21, 1998
PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE
K983731 · EIA
Pall Medical
Dental · 60d
Cleared Dec 21, 1998
PHILIPS INTEGRIS 3D RA OPTION
K983877 · IZI
Philips Medical Systems North...
Radiology · 49d
Cleared Dec 21, 1998
MIR SPIROBANK SPIROMETER
K983909 · BZG
Mir Medical Intl. Research Srl
Anesthesiology · 48d
Cleared Dec 21, 1998
OWEN MUMFORD 3ML AUTOPEN
K983974 · FMF
Owen Mumford USA, Inc.
General Hospital · 42d
Cleared Dec 18, 1998
NUVO BARRIER FILM
K980117 · KMF
Biomedical Development Co.
General & Plastic Surgery · 339d
Cleared Dec 18, 1998
CD SPINAL SYSTEM
K980184 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 332d
Cleared Dec 18, 1998
CORDIS NITINOL STENT AND DELIVERY SYSTEM
K980823 · FGE
Cordis Corp.
Gastroenterology & Urology · 290d
Cleared Dec 18, 1998
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
K982379 · HCI
Johnson & Johnson Professionals, Inc.
Neurology · 163d
Cleared Dec 18, 1998
RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
K982712 · CAC
Genzyme Surgical Product (Genzyme...
Anesthesiology · 136d
Cleared Dec 18, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
K983031 · LOJ
Ortho-Clinical Diagnostics, Inc.
Immunology · 109d
Cleared Dec 18, 1998
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE
K983297 · ESW
Medtronic Instent, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 18, 1998
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
K983306 · LTT
Accumed Intl., Inc.
Microbiology · 88d
Cleared Dec 18, 1998
SCS SPINAL SYSTEM
K983353 · KWP
Orthotec, Inc.
Orthopedic · 86d
Cleared Dec 18, 1998
DCI ENDOSCOPE
K983363 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 85d
Cleared Dec 18, 1998
AESCULAP MINOP SYSTEM
K983365 · GWG
Aesculap, Inc.
Neurology · 85d
Cleared Dec 18, 1998
ML UNIVERSAL TUBING
K983448 · MSR
Med-Logics, Inc.
Ophthalmic · 79d
Cleared Dec 18, 1998
ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN...
K983501 · LAG
Princeton BioMeditech Corp.
Toxicology · 73d
Cleared Dec 18, 1998
PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS
K983536 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 70d
Cleared Dec 18, 1998
STRYKER WEDGE SUTURE ANCHOR
K983557 · MBI
Stryker Endoscopy
Orthopedic · 66d