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
58153–58176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2007
T.B.R. ZIRCONNECT
K070935 · DZE
Sudimplant SA
Dental · 220d
Cleared Nov 09, 2007
DEPUY SPA POROUS COATED PROXIMAL SLEEVE
K071059 · KWZ
DePuy Orthopaedics, Inc.
Orthopedic · 207d
Cleared Nov 09, 2007
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM
K071413 · KRR
Arthrosurface, Inc.
Orthopedic · 172d
Cleared Nov 09, 2007
SPY FLUORESCENT IMAGING SYSTEM
K071619 · IZI
Novadaq Technologies, Inc.
Radiology · 149d
Cleared Nov 09, 2007
LUCENT
K071724 · MAX
Spinal Elements, Inc.
Orthopedic · 137d
Cleared Nov 09, 2007
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
K071760 · MUJ
Varian Medical Systems, Inc.
Radiology · 133d
Cleared Nov 09, 2007
TESLA GUARD, MODEL EFT G04
K071802 · MWI
Mammendorfer Institut Fur Physik Und...
Cardiovascular · 130d
Cleared Nov 09, 2007
MASTERGRAFT PUTTY
K071813 · MQV
Medtronic Sofamor Danek
Orthopedic · 130d
Cleared Nov 09, 2007
THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910
K071826 · QEZ
Fox Hollow Technologies
Cardiovascular · 129d
Cleared Nov 09, 2007
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
K071890 · MNH
Alphatec Spine, Inc.
Orthopedic · 123d
Cleared Nov 09, 2007
CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002
K071918 · DWJ
Thermogear, Inc.
Cardiovascular · 120d
Cleared Nov 09, 2007
OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER
K072156 · DQY
Usci Ireland
Cardiovascular · 98d
Cleared Nov 09, 2007
KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
K072216 · NEU
Kapp Surgical Instrument, Inc.
General & Plastic Surgery · 92d
Cleared Nov 09, 2007
PRIMACONNEX CAD/CAM ABUTMENT SYSTEM
K072241 · NHA
Lifecore Biomedical, Inc.
Dental · 88d
Cleared Nov 09, 2007
VIAPEEL PEELABLE INTRODUCER
K072248 · DYB
Enpath Medical, Inc.
Cardiovascular · 88d
Cleared Nov 09, 2007
SUPERCABLE GRIP AND PLATE SYSTEM
K072250 · KTT
Kinamed, Inc.
Orthopedic · 88d
Cleared Nov 09, 2007
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS...
K072378 · FRO
Arthrex, Inc.
General & Plastic Surgery · 77d
Cleared Nov 09, 2007
ADVANTIV SAFETY I.V. CATHETER
K072419 · FOZ
Smiths Medical Asd, Inc.
General Hospital · 73d
Cleared Nov 09, 2007
FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD
K072479 · EBI
Rapid Injection Systems Corp.
Dental · 66d
Cleared Nov 09, 2007
CXI SUPPORT CATHETER
K072724 · KRA
Cook, Inc.
Cardiovascular · 44d
Cleared Nov 09, 2007
MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
K072748 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 43d
Cleared Nov 09, 2007
SPEEDICATH COMPACT
K072808 · GBM
Coloplast Corp.
Gastroenterology & Urology · 39d
Cleared Nov 09, 2007
TRILOGY SYSTEM WITH RAPIDARC
K072916 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Nov 09, 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND...
K073016 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 15d