FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127225–127248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1990
REXTON PP 142, PP 142-L
K900636 · ESD
Rexton, Inc.
Ear, Nose, Throat · 46d
Cleared Mar 27, 1990
U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)
K900693 · FTC
Light Sources, Inc.
General & Plastic Surgery · 42d
Cleared Mar 27, 1990
ZZIPP INSTANT BOVIE CLEANER
K900714 · GEI
Grieshaber & Co.
General & Plastic Surgery · 41d
Cleared Mar 27, 1990
HEPARIN CONTROL PLASMA, FOR USE IN APTT
K900782 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Mar 27, 1990
RISTOCETIN
K900792 · GHR
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Mar 27, 1990
PROTEX LATEX EXAMINATION GLOVES
K900933 · LYY
Seyen Intl., Inc.
General Hospital · 27d
Cleared Mar 27, 1990
INTRAVENOUS STAND OR IV STAND
K900981 · FOX
Travl-Med Infusion Device Transport...
General Hospital · 25d
Cleared Mar 27, 1990
NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
K901111 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 18d
Cleared Mar 27, 1990
G.S.A. COLORED CONDOMS
K901112 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 18d
Cleared Mar 26, 1990
TEMPTEK T-1000 THERAPEUTIC COOLING UNIT
K891091 · ILO
Temptek, Inc.
Physical Medicine · 389d
Cleared Mar 26, 1990
ANSELL CONFORM GREEN EXAMINATION GLOVES
K897081 · LYZ
Ansell, Inc.
General Hospital · 97d
Cleared Mar 26, 1990
PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR
K897113 · CBK
Puritan Bennett Corp.
Anesthesiology · 90d
Cleared Mar 26, 1990
CVIS INSIGHT IMAGING CATHETER
K897153 · LYK
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 90d
Cleared Mar 26, 1990
ISOTRON 220
K900823 · IPF
Excel Tech. , Ltd.
Physical Medicine · 34d
Cleared Mar 26, 1990
URO TEX URINALS
K901000 · EYZ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 24d
Cleared Mar 26, 1990
BOUNDER VA POWER WHEELCHAIR
K901210 · ITI
21st Century Scientific, Inc.
Physical Medicine · 12d
Cleared Mar 26, 1990
ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED
K901240 · JDI
Med-Tek Corp.
Orthopedic · 11d
Cleared Mar 23, 1990
COLLAGEN NEUROSPONGE
K891993 · HBA
Vitaphore Corp.
Neurology · 360d
Cleared Mar 23, 1990
STP COMPLETE MODULE SET
K892425 · IYE
Leibinger & Fischer , Ltd.
Radiology · 347d
Cleared Mar 23, 1990
PLATELIA TOXO IGG KIT
K894947 · LGO
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 232d
Cleared Mar 23, 1990
DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6
K895792 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 176d
Cleared Mar 23, 1990
CATHETER EXTENSION SET CAT. NO. 48-3027-9
K895992 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 161d
Cleared Mar 23, 1990
TIP TOP(R) DISPENSER CAPS
K896670 · GJW
Helena Laboratories
Hematology · 116d
Cleared Mar 23, 1990
CLIP GUN WITH RANEY TYPE SCALP CLIPS
K896723 · HBO
Omni Medical Designs
Neurology · 114d