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
69385–69408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2004
HEMOSONIC 200HEMODYNAMIC MONITOR
K040802 · DPN
Arrow Intl., Inc.
Toxicology · 30d
Cleared Apr 28, 2004
.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
K040804 · IXI
Southeastern Radiation Products, Inc.
Radiology · 30d
Cleared Apr 28, 2004
MINI L.E.D. OEM MODULE
K040808 · EBZ
Satelec
Dental · 30d
Cleared Apr 28, 2004
MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
K040880 · JJY
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Apr 28, 2004
NORMAL AND HYPERGAMMA CONTROL SERUM
K040925 · JJY
Sebia
Immunology · 20d
Cleared Apr 28, 2004
RITA SYSTEMS
K040989 · GEI
Rita Medical Systems
General & Plastic Surgery · 12d
Cleared Apr 27, 2004
PORTACLAMP
K033085 · DXC
Cardio Life Research, S.A.
Cardiovascular · 211d
Cleared Apr 27, 2004
OSTEOGEN SBRG
K033098 · LYC
Impladent , Ltd.
Dental · 211d
Cleared Apr 27, 2004
CAUTION CONDOMS
K033163 · LTZ
Richard Van Haussen America, Inc.
Obstetrics & Gynecology · 172d
Cleared Apr 27, 2004
NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
K033171 · DZE
Northern Implants, LLC
Dental · 210d
Cleared Apr 27, 2004
RENACLEAN SH DIALYZER CLEANING SYSTEM
K033505 · LIF
Minntech Corp.
Gastroenterology & Urology · 174d
Cleared Apr 27, 2004
CALCIGEN -NAP BONE VOID FILLER
K033611 · MQV
Biomet, Inc.
Orthopedic · 162d
Cleared Apr 27, 2004
PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING
K033905 · KGO
Cardinalhealth
General Hospital · 132d
Cleared Apr 27, 2004
BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE...
K040054 · FQM
Theodore Barash
General Hospital · 106d
Cleared Apr 27, 2004
CLIRPATH EXCIMER LASER CATHETER
K040067 · PDU
Spectranetics Corp.
Cardiovascular · 104d
Cleared Apr 27, 2004
DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
K040185 · HIS
Ssl Americas
Obstetrics & Gynecology · 91d
Cleared Apr 27, 2004
MODEL GST-1
K040193 · GZJ
Medical Equipment Device Specialists
Neurology · 90d
Cleared Apr 27, 2004
HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)
K040440 · DWJ
Http Hypothermia Therapy
Cardiovascular · 67d
Cleared Apr 27, 2004
AQUADEX SYSTEM 100, MODEL A1100
K040489 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 61d
Cleared Apr 27, 2004
IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS
K040546 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 56d
Cleared Apr 27, 2004
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
K040632 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 48d
Cleared Apr 27, 2004
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
K040702 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 41d
Cleared Apr 27, 2004
STRYKER T4 HYTREL ZIPPER TOGA
K040764 · FYA
Stryker Corp.
General Hospital · 33d
Cleared Apr 27, 2004
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
K040984 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 12d