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
125953–125976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1990
CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S
K902492 · DRI
Datex Division Instrumentarium Corp.
Cardiovascular · 31d
Cleared Jul 06, 1990
CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
K902493 · DRI
Datex Division Instrumentarium Corp.
Cardiovascular · 31d
Cleared Jul 06, 1990
WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
K902538 · HRY
Dow Corning Wright
Orthopedic · 30d
Cleared Jul 05, 1990
POLYSORB SYNTHETIC ABSORBABLE SUTURE
K895579 · GAN
United States Surgical, A Division of...
General & Plastic Surgery · 293d
Cleared Jul 05, 1990
DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
K900198 · GAN
American Cyanamid Co.
General & Plastic Surgery · 170d
Cleared Jul 05, 1990
NONABSORBABLE NYLON SURGICAL SUTURE*
K900531 · GAR
United States Surgical, A Division of...
General & Plastic Surgery · 150d
Cleared Jul 05, 1990
MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER
K900788 · CEM
Datachem, Inc.
Chemistry · 135d
Cleared Jul 05, 1990
SUNGLASSES
K900944 · HQY
K Mart Apparel Corp.
Ophthalmic · 127d
Cleared Jul 05, 1990
60 FUNDUS CAMERA CF-60UV
K901839 · HJI
Canon USA, Inc.
Ophthalmic · 72d
Cleared Jul 05, 1990
SUNGLASSES - IMPACT RESISTANT LENSES (ACRYLIC)
K901945 · HQY
Zebco Corp.
Ophthalmic · 66d
Cleared Jul 05, 1990
STRIPE PROJECTOR
K902138 · HJI
Academic Catalyst Corp.
Ophthalmic · 56d
Cleared Jul 05, 1990
PIEZO HANDPIECE
K902150 · HQC
United Surgical Corp.
Ophthalmic · 51d
Cleared Jul 05, 1990
TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
K902243 · KLS
Technicon Instruments Corp.
Chemistry · 48d
Cleared Jul 05, 1990
SOLAR-MATES SUNGLASSES, BONJOUR EYEWEAR
K902322 · HQY
Nevitt Sales Corp.
Ophthalmic · 42d
Cleared Jul 05, 1990
OPUS TSH TEST SYSTEM
K902333 · JLW
Pb Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Jul 05, 1990
SUNSHADES, ACRYLIC LENSES, ORDER #SG-01
K902385 · HQY
Tel-Time Products
Ophthalmic · 36d
Cleared Jul 03, 1990
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · GWM
Abbott Laboratories
Neurology · 592d
Cleared Jul 03, 1990
CARDIAC OUTPUT COMPUTER, MODEL COM-3
K896930 · DXG
Baxter Healthcare Corp
Cardiovascular · 204d
Cleared Jul 03, 1990
ACUSON V328 AND C5432 TRANSDUCERS
K897151 · JTX
Acuson Corp.
Microbiology · 189d
Cleared Jul 03, 1990
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
K900246 · DSI
Ppg Industries, Inc.
Cardiovascular · 167d
Cleared Jul 03, 1990
PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE
K900269 · FFL
Porges Corp.
Gastroenterology & Urology · 166d
Cleared Jul 03, 1990
ORTH-EVAC TM
K900325 · CAC
Deknatel, Inc.
Anesthesiology · 161d
Cleared Jul 03, 1990
BURNS CASUALTY SHEET
K900441 · FPY
Pilgrim Medical Services
General & Plastic Surgery · 154d
Cleared Jul 03, 1990
BURNS CASUALTY SHEET BURN ROLL
K900442 · FPY
Pilgrim Medical Services
General & Plastic Surgery · 154d