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
128065–128088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1990
MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS
K896976 · CAK
Asahi Medical Co., Ltd.
General Hospital · 42d
Cleared Jan 24, 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2
K900072 · LJM
General Biometrics, Inc.
Immunology · 19d
Cleared Jan 24, 1990
ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER
K900160 · KQM
Jedmed Instrument Co.
General & Plastic Surgery · 12d
Cleared Jan 24, 1990
4/1 ARMBOARD
K900175 · BTX
Infection Control Products, Inc.
General & Plastic Surgery · 12d
Cleared Jan 23, 1990
SEAMLESS LATEX PATIENT EXAMINATION GLOVES
K891490 · LYY
Med-Care Sdn. Bhd.
General Hospital · 313d
Cleared Jan 23, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892307 · LYY
Guangming Latex Factory
General Hospital · 292d
Cleared Jan 23, 1990
EXAM GLOVES (MFG. GUEY HER ENT. CO. LTD)
K893025 · LYY
Wen Hao, Inc.
General Hospital · 286d
Cleared Jan 23, 1990
BESTONE MODEL ITE & CANAL
K893887 · ESD
Bestone Hearing Instruments
Ear, Nose, Throat · 238d
Cleared Jan 23, 1990
AE-105D DIAGNOSTIC TYMPANOMETER
K894260 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 217d
Cleared Jan 23, 1990
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE
K894888 · JAK
Shimadzu Medical Systems
Radiology · 175d
Cleared Jan 23, 1990
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
K895310 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 147d
Cleared Jan 23, 1990
MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
K895640 · HIS
Armkel, LLC
Obstetrics & Gynecology · 126d
Cleared Jan 23, 1990
FIBEROPTIC LIGHT SOURCE, FOI-1A
K896384 · EQH
Jedmed Instrument Co.
Ear, Nose, Throat · 78d
Cleared Jan 23, 1990
R-150-ET COLLIMATOR
K896486 · IZX
Advantech
Radiology · 71d
Cleared Jan 23, 1990
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
K896514 · GIM
Radiometer America, Inc.
Chemistry · 70d
Cleared Jan 23, 1990
PC/QCT QUANTITATIVE SOFTWARE
K896677 · KGI
The Institute For Radiological Image...
Radiology · 57d
Cleared Jan 23, 1990
MODEL 6000
K896789 · LNH
Medical Advances, Inc.
Radiology · 50d
Cleared Jan 23, 1990
NIIC LASER SYSTEM
K896988 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 49d
Cleared Jan 23, 1990
LATEX PATIENT EXAMINATION GLOVES
K897139 · LYY
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 27d
Cleared Jan 23, 1990
SURETEX LATEX EXAMINATION GLOVES
K900212 · LYY
Gulf Medical Technologies, Inc.
General Hospital · 6d
Cleared Jan 22, 1990
J.M. PATIENT EXAMINATION GLOVES
K891624 · LYY
Jann Maw (U.S.A.), Inc.
General Hospital · 308d
Cleared Jan 22, 1990
PATIENT EXAMINATION GLOVES
K893074 · LYY
Taba Gloves Pvt. , Ltd.
General Hospital · 284d
Cleared Jan 22, 1990
SURGEON'S GLOVES
K893522 · FGO
Thai Fuji Latex Co., Ltd.
Gastroenterology & Urology · 259d
Cleared Jan 22, 1990
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
K894030 · HFM
Healthdyne, Inc.
Obstetrics & Gynecology · 230d