Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
145633–145656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1986
IN LINE VALVE CATALOG NO. 2000A
K854965 · FPA
Rao Medical Devices, Inc.
General Hospital · 72d
Cleared Feb 21, 1986
MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
K855093 · HHR
Endo Lase, Inc.
Obstetrics & Gynecology · 63d
Cleared Feb 21, 1986
RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR
K855108 · JJQ
Biomaterials International, Inc.
Chemistry · 60d
Cleared Feb 21, 1986
BUNN LITE OXYGEN CONCENTRATOR
K855208 · CAW
The John Bunn Co.
Anesthesiology · 53d
Cleared Feb 21, 1986
PARA-PAK MACRO-CON
K860034 · LKS
Meridian Diagnostics, Inc.
Microbiology · 46d
Cleared Feb 21, 1986
EASY-TEST UREA (BUN) REAGENT
K860135 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Feb 21, 1986
DIRECT BILIRUBIN
K860257 · CIG
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Feb 21, 1986
TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT
K860326 · KKX
Deroyal Industries, Inc.
General Hospital · 23d
Cleared Feb 21, 1986
BASICAM S COUNTER BALANCE CAMERA
K860454 · IXY
Siemens Gammasonics, Inc.
Radiology · 16d
Cleared Feb 21, 1986
LSP MINILATOR
K860516 · BXY
Life Support Products, Inc.
Anesthesiology · 10d
Cleared Feb 21, 1986
CPRCOACH VOICE PROMPTER & CPR PROMPTER RESCUE AID
K860555
Auralogic
Cardiovascular · 7d
Cleared Feb 21, 1986
SERIES 7050 CAPNOGRAPH
K860556 · CCK
Marquette Electronics, Inc.
Anesthesiology · 7d
Cleared Feb 21, 1986
DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315
K860583 · JAY
Dale Medical Products, Inc.
Anesthesiology · 3d
Cleared Feb 20, 1986
INTRACRANIAL PRESSURE MONITORING KIT 070
K853864 · GWM
Camino Laboratories, Inc.
Neurology · 156d
Cleared Feb 20, 1986
ACUSON L312 TRANSDUCER
K853966 · ITX
Acuson Computed Sonography
Radiology · 147d
Cleared Feb 20, 1986
GHAJAR INTRAVENTRICULAR CATHETER GUIDE
K854475 · HAW
Sparta Instrument Corp.
Neurology · 105d
Cleared Feb 20, 1986
INSERTION GAIN OPTIMIZER IGO-1000
K854535 · ETW
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 99d
Cleared Feb 20, 1986
SONOLAYER S, SSH-65A
K854606 · DXK
Toshiba Medical Systems
Cardiovascular · 94d
Cleared Feb 20, 1986
PHOTIC-100 SPECTROPHOTOMETER
K854679 · JJQ
Future Impex Corp.
Chemistry · 92d
Cleared Feb 20, 1986
OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE
K854742 · ESD
Oticon Corp.
Ear, Nose, Throat · 87d
Cleared Feb 20, 1986
OMKNEE SYSTEM, POROUS COATED
K854943
Orthomet, Inc.
Orthopedic · 72d
Cleared Feb 20, 1986
FIBER MESH
K854977 · DZE
Pulpdent Corp. of America
Dental · 70d
Cleared Feb 20, 1986
KWI (TM) G-CO/TWO
K855172 · JSK
Micro-Bio-Logics
Microbiology · 56d
Cleared Feb 20, 1986
AUSTIN ENTERIC SYSTEM
K860194 · JSE
Austin Biological Laboratories
Microbiology · 29d