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
161545–161568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1982
DATASCOPE MODIFIED #82 IABP SYSTEM
K813182 · DSP
Datascope Corp.
Cardiovascular · 139d
Cleared Mar 31, 1982
EPCOM EMS SCAN II
K813275 · IYO
Epcom Medical Systems, Inc.
Radiology · 128d
Cleared Mar 31, 1982
HEMOFILTERS
K813591 · KDI
Amicon, Inc.
Gastroenterology & Urology · 93d
Cleared Mar 31, 1982
DELTA PLAN II RADIATION THERAPY PLAN
K820310 · IYE
Technicare Corp.
Radiology · 54d
Cleared Mar 31, 1982
AM. PH. STERILE PLASTIC CONNECTING TUBES
K820412 · BYY
American Pharmaseal Div. Ahsc
General Hospital · 47d
Cleared Mar 31, 1982
ARS-1000
K820448 · IYE
Applied Radiation
Radiology · 41d
Cleared Mar 31, 1982
SPECTRA305
K820492 · FTC
Ultralite
General & Plastic Surgery · 36d
Cleared Mar 31, 1982
LASER GAS MIXTURES
K820535 · EWG
Union Carbide Corp.
Toxicology · 29d
Cleared Mar 31, 1982
XENAMATIC SERIES OF XENON REBREATH DEV
K820571 · IYT
Diversified P.A.
Radiology · 29d
Cleared Mar 31, 1982
TENSOPLAST SKIN TRACTION KIT
K820612 · HST
Smith & Nephew, Inc.
Neurology · 23d
Cleared Mar 31, 1982
ARRANGE TM
K820688 · JAK
General Electric Co.
Radiology · 19d
Cleared Mar 31, 1982
COBE PPD 1.3L, #18-520-009
K820694 · FJG
Cobe Laboratories, Inc.
Gastroenterology & Urology · 19d
Cleared Mar 31, 1982
DELTA PLAN II RADIATION THERAPY PLANNING SYSTEM
K827122
Technicare Corp.
Radiology · 54d
Cleared Mar 31, 1982
ARS-1000 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K827175
Applied Radiation
Radiology · 41d
Cleared Mar 26, 1982
SHEFFIELD INFANT VENTILATOR MARK 4
K812961 · CBK
Cairco , Ltd.
Anesthesiology · 156d
Cleared Mar 26, 1982
REUSABLE & DISPOSABLE TEMP. PROBES
K813459 · FLL
Electromedics, Inc.
General Hospital · 115d
Cleared Mar 26, 1982
CENTRIA PROLACTIN TEST SET
K813572 · CFT
Ventrex Laboratories, Inc.
Chemistry · 94d
Cleared Mar 26, 1982
CARDIOVASCULAR TEMP. PACEMAKER ELEC
K820003 · LDF
Diag Corp.
Cardiovascular · 81d
Cleared Mar 26, 1982
RESUSCITATION MASK
K820059 · BTM
Cederroth, Inc. USA
Anesthesiology · 74d
Cleared Mar 26, 1982
GORE-TEX TISSUE REINFORCEMENT PATCH
K820193 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 60d
Cleared Mar 26, 1982
RETRIEVAL FORCEPS
K820239 · KOD
American Endoscopy, Inc.
Gastroenterology & Urology · 56d
Cleared Mar 26, 1982
PAPILLOTOMES
K820240 · KNS
American Endoscopy, Inc.
Gastroenterology & Urology · 56d
Cleared Mar 26, 1982
ADAPTAID TEMP. PACING EXT. LEAD #366-02
K820268 · DSA
Intermedics, Inc.
Cardiovascular · 52d
Cleared Mar 26, 1982
FOLLICLE STIMULATING HORMONE KIT
K820358 · CGJ
Pcl-Ria, Inc.
Chemistry · 45d