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
70321–70344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2003
EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
K031898 · GKR
Ekf Diagnostic GmbH
Hematology · 97d
Cleared Sep 24, 2003
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
K031971 · HSD
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Sep 24, 2003
TELEMIS-MEDICAL SOLUTION
K032157 · LLZ
Telemis S.A.
Radiology · 72d
Cleared Sep 24, 2003
JUSTWIN SCOOTER, MODEL JS-401
K032277 · INI
Joy Ride Tech Co., Ltd.
Physical Medicine · 63d
Cleared Sep 24, 2003
RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,
K032402 · IOR
Convaid Products, Inc.
Physical Medicine · 51d
Cleared Sep 24, 2003
WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
K032489 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 43d
Cleared Sep 24, 2003
AIR PRESS MASSAGER
K032505 · IRP
Telebrands Corp
Physical Medicine · 42d
Cleared Sep 24, 2003
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
K032635 · LMC
Agfa Corp.
Radiology · 29d
Cleared Sep 24, 2003
MODIFICATION TO: AURORA
K032678 · LNH
Aurora Imaging Technology, Inc.
Radiology · 26d
Cleared Sep 24, 2003
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
K032681 · LMC
Konica Medical and Graphic Corporation
Radiology · 26d
Cleared Sep 24, 2003
INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC
K032780 · MEG
Inviro Medical
General Hospital · 16d
Cleared Sep 23, 2003
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
K023429 · MNW
Rowenta, Inc.
Gastroenterology & Urology · 347d
Cleared Sep 23, 2003
PALACOS R
K030902 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 183d
Cleared Sep 23, 2003
OSTEOPAL
K030903 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 183d
Cleared Sep 23, 2003
PALAMED
K030904 · LOD
Heraeus Medical GmbH Technology
Orthopedic · 183d
Cleared Sep 23, 2003
CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
K030966 · NAJ
Boston Scientific Corp
Obstetrics & Gynecology · 180d
Cleared Sep 23, 2003
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K031214 · KWQ
Encore Medical, L.P.
Orthopedic · 159d
Cleared Sep 23, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031305 · LFL
Olympus Optical Co., Ltd.
General & Plastic Surgery · 152d
Cleared Sep 23, 2003
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE...
K031449 · KWS
Implex Corp.
Orthopedic · 139d
Cleared Sep 23, 2003
S&T MICROSURGICAL SUTURE
K031531 · GAR
S & T AG
General & Plastic Surgery · 131d
Cleared Sep 23, 2003
STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING
K031669 · KGO
P.T. Saptindo Surgica
General Hospital · 117d
Cleared Sep 23, 2003
STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING
K031670 · KGO
P.T. Saptindo Surgica
General Hospital · 117d
Cleared Sep 23, 2003
KSEA OPSERVER LAP
K031895 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 96d
Cleared Sep 23, 2003
PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
K031897 · INI
Imc-Heart Way LLC
Physical Medicine · 96d