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
118873–118896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1991
2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)
K914114 · LNH
Resonex, Inc.
Radiology · 82d
Cleared Dec 04, 1991
ABSORBENT FIBER
K914431 · NAB
Ulti-Med Intl., Inc.
General & Plastic Surgery · 61d
Cleared Dec 04, 1991
GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE
K914449 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 61d
Cleared Dec 04, 1991
ETHICON ABSORBABLE SUTURE CLIP AND APPLIER
K914549 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 54d
Cleared Dec 04, 1991
SORBSAN TOPICAL WOUND DRESSING (MODIFIED)
K914575 · NAC
Dow B. Hickam, Inc.
General & Plastic Surgery · 50d
Cleared Dec 04, 1991
MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF
K914742 · DTR
Medtronic Vascular
Cardiovascular · 84d
Cleared Dec 04, 1991
ALGINATE FIBER
K914779 · NAC
Adri/Technam
General & Plastic Surgery · 42d
Cleared Dec 04, 1991
EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER
K914810 · JGS
Medica Corp.
Chemistry · 40d
Cleared Dec 04, 1991
GAUZE BANDAGE ROLL
K914842 · NAB
Cal West Trading Co.
General & Plastic Surgery · 37d
Cleared Dec 04, 1991
DIAZO COLORIMETRY, BILIRUBIN
K914873 · CIG
Pointe Scientific, Inc.,
Chemistry · 36d
Cleared Dec 04, 1991
PROMEON 63B SURGICAL TAPE
K914912 · KGX
Promeon
General & Plastic Surgery · 33d
Cleared Dec 04, 1991
STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES
K914937 · NAB
Kerma Medical Products, Inc.
General & Plastic Surgery · 30d
Cleared Dec 04, 1991
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
K914971 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 47d
Cleared Dec 03, 1991
IL TEST(TM) COCAINE
K913737 · JXO
Instrumentation Laboratory CO
Toxicology · 105d
Cleared Dec 03, 1991
IMPERVA DUAL
K913946 · KLE
Shofu Dental Corp.
Dental · 90d
Cleared Dec 02, 1991
SI-450/ILUS (INTRALUMINAL ULTRASOUND)
K912361 · ITX
Siemens Ultrasound, Inc.
Radiology · 187d
Cleared Dec 02, 1991
URODYNAMIC RECTAL BALLOON
K912451 · FAP
Cook Urological, Inc.
Gastroenterology & Urology · 182d
Cleared Dec 02, 1991
LUHR PAN FIXATION SYSTEM
K913355 · HRS
Howmedica Corp.
Orthopedic · 126d
Cleared Dec 02, 1991
FRUCTOSAMINE ABG21 TEST SYSTEM
K913614 · LCP
Boehringer Mannheim Corp.
Hematology · 111d
Cleared Dec 02, 1991
HUMAN IGD IMMUNOLOGICAL NL TEST KIT
K913671 · CZJ
The Binding Site, Ltd.
Immunology · 105d
Cleared Dec 02, 1991
SIEMENS SI-400
K914013 · IYO
Siemens Ultrasound, Inc.
Radiology · 84d
Cleared Dec 02, 1991
REPEL(TM) LITE CUT RESISTANT GLOVE LINERS
K914077 · LYU
Depuy-Raynham
General Hospital · 82d
Cleared Dec 02, 1991
MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM
K914328 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 66d
Cleared Dec 02, 1991
QUALTEX MAGNETIC INSTRUMENT DRAPE
K914369 · KKX
Deroyal Industries, Inc.
General Hospital · 62d