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
70849–70872 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 23, 2003
VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
K031944 · LZA
Arista Latindo Industrial Ltd. P.T
General Hospital · 91d
Cleared Sep 23, 2003
PERSONNA PLUS SAFETY SCALPEL SYSTEM
K032242 · GES
Omi Manufacturing Pty., Ltd.
General & Plastic Surgery · 64d
Cleared Sep 23, 2003
MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932)
K032364 · FLL
Microlife Intellectual Property GmbH
General Hospital · 54d
Cleared Sep 23, 2003
F-11 FOLDING POWER CHAIR
K032440 · ITI
Wheelchair & Scooter Express
Physical Medicine · 47d
Cleared Sep 23, 2003
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
K032468 · GAQ
Suturtek Incorporated
General & Plastic Surgery · 43d
Cleared Sep 23, 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS...
K032553 · HCG
Cordis Neurovascular, Inc.
Neurology · 35d
Cleared Sep 23, 2003
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6...
K032606 · JWH
Exactech, Inc.
Orthopedic · 29d
Cleared Sep 23, 2003
BEELINE SYSTEM
K032642 · FRN
Mckinley, Inc.
General Hospital · 27d
Cleared Sep 23, 2003
CONTOUR SE MICROSPHERES (SYRINGE)
K032707 · HCG
Boston Scientific Corp
Neurology · 21d
Cleared Sep 23, 2003
MODULAR PLUS HIP STEM
K032709 · LWJ
Plus Orthopedics
Orthopedic · 21d
Cleared Sep 23, 2003
EYESOPEN TONOMETER
K032769 · HKY
Eye-Deas, LLC
Ophthalmic · 15d
Cleared Sep 23, 2003
MEDRAD CONTINUUM MR INFUSION SYSTEM
K032771 · FRN
Medrad, Inc.
General Hospital · 15d
Cleared Sep 23, 2003
DIAMOND D HIGH IMPACT DENTURE ACRYLIC
K032773 · EBI
Mycone Dental Supply Co., Inc.
Dental · 15d
Cleared Sep 23, 2003
MYOSYSTEM WITH CUSTOMIZING
K032833 · GXY
Otto Bock Healthcare LP
Neurology · 12d
Cleared Sep 22, 2003
MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
K023983 · KWQ
Highgate Orthopaedics
Orthopedic · 294d