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

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176,076 results
57649–57672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2008
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING...
K073473 · OBJ
Volcano Corporation
Radiology · 34d
Cleared Jan 14, 2008
START JUNIOR
K073512 · IOR
Otto Bock Healthcare LP
Physical Medicine · 31d
Cleared Jan 14, 2008
MERITS E700 PORCE LIFT
K073513 · ING
Merits Health Products Co., Ltd.
Physical Medicine · 31d
Cleared Jan 11, 2008
A&J POCA01 OXYGEN CONCENTRATOR
K071608 · CAW
Zhongshan A&J Medical Equipment Co.,...
Anesthesiology · 213d
Cleared Jan 11, 2008
AVIATOR INSULIN PUMP
K071788 · LZG
Abbott Diabetes Care, Inc.
General Hospital · 193d
Cleared Jan 11, 2008
HYDROCOIL EMBOLIC SYSTEMS (HES)
K071939 · KRD
MicroVention, Inc.
Cardiovascular · 182d
Cleared Jan 11, 2008
HEARTEVENT, MODEL AT
K072385 · DXH
Diagnostic Devices Pty, Ltd.
Cardiovascular · 140d
Cleared Jan 11, 2008
LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000
K072688 · CAW
International Biophysics Corp.
Anesthesiology · 109d
Cleared Jan 11, 2008
CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
K072790 · FMF
Confluent Surgical,Inc
General Hospital · 102d
Cleared Jan 11, 2008
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
K073038 · DRG
Carematix, Inc.
Cardiovascular · 74d
Cleared Jan 11, 2008
NOBELREPLACE HEXAGONAL IMPLANT
K073142 · DZE
Nobel Biocare USA, LLC
Dental · 65d
Cleared Jan 11, 2008
SLIT LAMP
K073190 · HJO
Huvitz Co., Ltd.
Ophthalmic · 59d
Cleared Jan 11, 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP...
K073198 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 59d
Cleared Jan 11, 2008
MICROSHEATH XL CATHETERS
K073289 · DQY
Flowcardia, Inc.
Cardiovascular · 51d
Cleared Jan 11, 2008
MODIFICATION TO: ARAGON SURGICAL LAPCAP
K073452 · HIF
Aragon Surgical, Inc.
Obstetrics & Gynecology · 32d
Cleared Jan 11, 2008
MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
K073462 · MHX
Ge Medical Systems Information...
Cardiovascular · 32d
Cleared Jan 11, 2008
EEG-1100A SWITCH BOX
K073491 · OLV
Nihon Kohden America, Inc.
Neurology · 30d
Cleared Jan 11, 2008
TRANS1 AXIAL FIXATON SYSTEM
K073514 · KWQ
Trans1 Incorporated
Orthopedic · 28d
Cleared Jan 11, 2008
MODIFICATION TO: BPCARD, MODEL Z-7000-0700
K073630 · DXN
Qrs Diagnostic, LLC
Cardiovascular · 16d
Cleared Jan 10, 2008
MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES
K071782 · OLV
Micromed S.P.A.
Neurology · 192d
Cleared Jan 10, 2008
VARI-LASE WIRE FIBER
K072332 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 143d
Cleared Jan 10, 2008
SMITH & NEPHEW MIS HIP STEM
K072417 · LPH
Smith & Nephew, Inc.
Orthopedic · 135d
Cleared Jan 10, 2008
SYNTHES OC FUSION AND SYNAPSE SYSTEMS
K072434 · MNI
Synthes Spine Co.Lp
Orthopedic · 134d
Cleared Jan 10, 2008
PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM
K072703 · KWQ
Pioneer Surgical Technology
Orthopedic · 108d