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
87625–87648 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 18, 1998
MODULAP
K983623 · GCJ
Atc Technologies, Inc.
General & Plastic Surgery · 64d
Cleared Dec 18, 1998
C.T.M. MOBILITY SCOOTER, MODEL # HS-686
K983662 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 60d
Cleared Dec 18, 1998
C.T.M. MOBILITY SCOOTER, MODEL # HS-666
K983663 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 60d
Cleared Dec 18, 1998
SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS
K983733 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 57d
Cleared Dec 18, 1998
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
K983741 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 57d
Cleared Dec 18, 1998
YASARGIL TITANIUM ANEURYSM CLIPS
K983758 · HCH
Aesculap, Inc.
Neurology · 53d
Cleared Dec 18, 1998
SYNTHES SYNMESH
K983766 · EZX
Synthes (Usa)
General & Plastic Surgery · 53d
Cleared Dec 18, 1998
MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
K983777 · CAW
Invacare Corp.
Anesthesiology · 53d
Cleared Dec 18, 1998
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K983780 · LPN
Alcon Laboratories
Ophthalmic · 52d
Cleared Dec 18, 1998
TRANSFERRIN SPQ III ANTIBODY REAGENT SET
K983880 · DDG
DiaSorin, Inc.
Immunology · 46d
Cleared Dec 18, 1998
DEPUY ORTHOTECH SPIKED WASHER
K983906 · HTN
DePuy Orthopaedics, Inc.
Orthopedic · 45d
Cleared Dec 18, 1998
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
K983924 · DHN
Immuno Concepts, Inc.
Immunology · 44d
Cleared Dec 18, 1998
OPTI-ONE MULTI-PURPOSE SOLUTION
K983973 · LPN
Alcon Laboratories
Ophthalmic · 39d
Cleared Dec 18, 1998
LASERSCOPE COOLSPOT
K984110 · GEX
Laserscope
General & Plastic Surgery · 31d
Cleared Dec 18, 1998
MODIFICATION TO SKVEKPATCH
K984177 · KMF
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 28d