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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
64801–64824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 2005
TRIAGE BNP TEST, MODEL 98000XR
K051787 · NBC
Biosite Incorporated
Chemistry · 83d
Cleared Sep 22, 2005
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
K052047 · HGX
Avent America, Inc.
Obstetrics & Gynecology · 55d
Cleared Sep 22, 2005
CYSTOGLIDE DILATING INTRODUCER SHEATH
K052134 · KNY
Percutaneous Systems, Inc.
Gastroenterology & Urology · 48d
Cleared Sep 22, 2005
21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)
K052199 · LLZ
Totoku Electric Co., Ltd.
Radiology · 41d
Cleared Sep 22, 2005
SIMTEC IM-MAXX 2 OPTION
K052315 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Sep 22, 2005
MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
K052372 · DWF
Medtronic Perfusion Systems
Cardiovascular · 23d
Cleared Sep 22, 2005
ACUSON SEQUOIA ULTRASOUND SYSTEM
K052410 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Sep 22, 2005
SYNGO IMAGING VERSION V20A
K052461 · LLZ
Siemens AG Medical Solutions
Radiology · 14d
Cleared Sep 21, 2005
20G SMA LASER FIBER, MODEL LF100
K050807 · HQF
Ophthalmed, LLC
Ophthalmic · 175d
Cleared Sep 21, 2005
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
K051494 · MQB
Cr Tech, Ltd.
Radiology · 107d
Cleared Sep 21, 2005
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
K051540 · NFB
Inovo, Inc.
Anesthesiology · 103d
Cleared Sep 21, 2005
SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM
K051678 · HSB
Synthes (Usa)
Orthopedic · 90d
Cleared Sep 21, 2005
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
K051697 · MNH
Medical Device Advisory Development...
Orthopedic · 90d
Cleared Sep 21, 2005
TRITON/TRU-TRAC/TX TRACTION DEVICES
K051938 · ITH
Chattanooga Group
Physical Medicine · 65d
Cleared Sep 21, 2005
REPROCESSED EXTERNAL FIXATION DEVICE
K051957 · KTT
Sterilemed, Inc.
Orthopedic · 68d
Cleared Sep 21, 2005
OXY-SERVE II OXYGEN CONSERVING REGULATOR
K051988 · NFB
Superior Products, Inc.
Anesthesiology · 61d
Cleared Sep 21, 2005
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K052091 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 50d
Cleared Sep 21, 2005
EBI DYNAFIX VISION FOOTPLATE SYSTEM
K052239 · KTT
Ebi, L.P.
Orthopedic · 35d
Cleared Sep 21, 2005
GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000
K052274 · GEI
Guidant Corporation
General & Plastic Surgery · 30d
Cleared Sep 21, 2005
NIO 2MP-20 AND E-2620 S
K052276 · LLZ
Barcoview
Radiology · 30d
Cleared Sep 21, 2005
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
K052293 · LNH
Ge Medical Systems, LLC
Radiology · 29d
Cleared Sep 21, 2005
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
K052317 · MNI
Stryker Spine
Orthopedic · 27d
Cleared Sep 21, 2005
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
K052329 · GZI
Innovative Neurotronics, Inc.
Neurology · 27d
Cleared Sep 21, 2005
AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER
K052332 · NVP
Trudell Medical Intl.
Anesthesiology · 26d