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
78481–78504 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
K011751 · INI
Merits Health Products., Inc.
Physical Medicine · 61d
Cleared Aug 06, 2001
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K012282 · LYZ
Cypress Medical Products, Ltd.
General Hospital · 17d
Cleared Aug 06, 2001
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER...
K981693 · LFD
Gebauer Co.
Dental · 1181d
Cleared Aug 06, 2001
DISPO ETCH
K984380 · KOJ
Kis Products
Dental · 972d
Cleared Aug 06, 2001
DISPODRILL
K993124 · KOJ
Kis Products
Dental · 686d
Cleared Aug 06, 2001
DISPOPROPHY
K993182 · KOJ
Kis Products
Dental · 683d
Cleared Aug 03, 2001
MICROSTIM 100I TENS DEVICE
K010295 · GZJ
Microstim, Inc.
Neurology · 184d
Cleared Aug 03, 2001
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
K010345 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 179d
Cleared Aug 03, 2001
GEO STRUCTURE
K010530 · MQP
Interpore Cross Intl.
Orthopedic · 161d
Cleared Aug 03, 2001
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
K011031 · MMW
Vysis
Immunology · 120d
Cleared Aug 03, 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · HWC
Aesculap, Inc.
Orthopedic · 114d
Cleared Aug 03, 2001
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE
K011386 · MQV
Ebi, L.P.
Orthopedic · 88d
Cleared Aug 03, 2001
PERSYST REVEAL
K011397 · OMB
Persyst Development Corp.
Neurology · 88d
Cleared Aug 03, 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d
Cleared Aug 03, 2001
IN SPACE 3D
K011447 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Aug 03, 2001
MP-3C POWER BASE CHAIR, MODEL MP3C
K011687 · ITI
Merits Health Products., Inc.
Physical Medicine · 64d
Cleared Aug 03, 2001
SUPREMCAST
K011705 · EJH
American Dent-All, Inc.
Dental · 60d
Cleared Aug 03, 2001
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
K011707 · INI
Merits Medical Industries Co., Ltd.
Physical Medicine · 60d
Cleared Aug 03, 2001
FIRST FILL R.C.S.
K011748 · KIF
Jeneric/Pentron, Inc.
Dental · 58d
Cleared Aug 03, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
K011753 · INI
Merits Health Products., Inc.
Physical Medicine · 58d
Cleared Aug 03, 2001
THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
K011768 · LSB
Thermo-Electric Co.
Physical Medicine · 57d
Cleared Aug 03, 2001
ADVANCED HIP ASSESSMENT SOFTWARE
K011917 · KGI
Ge Lunar Corp.
Radiology · 44d
Cleared Aug 03, 2001
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
K011971 · HAW
Image-Guided Neurologics, Inc.
Neurology · 39d
Cleared Aug 03, 2001
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS...
K012068 · MQE
Sims Portex , Ltd.
Obstetrics & Gynecology · 32d